Division 3.2Conformity assessment procedures

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## Part 1—Preliminary #### 1.1 Name of Regulations These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002. #### 1.3 Definitions—the dictionary etc (1) The dictionary at the end of these Regulations defines certain words and expressions, and includes, for that purpose, references to certain words and expressions that are defined in the Act or elsewhere in these Regulations (signpost definitions). > Note: Example: The signpost definition ‘medical device—see section 41BD of the Act’ means that the expression medical device is defined in section 41BD of the Therapeutic Goods Act 1989. > Note: The dictionary only includes a signpost definition for a word or expression that is defined elsewhere in these Regulations if the word or expression is used in more than one regulation. (2) The dictionary is part of these Regulations. (3) A definition in these Regulations applies to each use of the word or expression in these Regulations, unless the contrary intention appears. #### 1.4 Medical devices with a measuring function (1) For these Regulations, a medical device has a measuring function if the device is intended by the manufacturer to measure: (a) quantitatively a physiological or anatomical parameter; or (b) a quantity, or a qualifiable characteristic, of energy or substances delivered to or removed from the human body. (2) This regulation does not apply to an IVD medical device. #### 1.5 Refurbishment (Act s 3(1)) (1) A refurbishment of a medical device is taken to have occurred if the medical device, or a part of the device, is substantially rebuilt from one or more used medical devices of that kind so as to create a medical device that is able to be used for the purpose originally intended by the manufacturer of the original device. (2) Without limiting subregulation (1), a refurbishment of a medical device may involve the following actions: (a) stripping the device into component parts or sub‑assemblies; (b) checking parts of the device for suitability for reuse; (c) replacing component parts or sub‑assemblies of the device that are not suitable for reuse; (d) assembling reclaimed or replacement component parts or sub‑assemblies of the device or another used device; (e) testing a reassembled device against the specifications of the original device or, if the manufacturer has revised those specifications, the revised specifications; (f) identifying an assembled device as a refurbished device. #### 1.6 Kinds of medical devices—other common characteristics (Act s 41BE(1)(e)) For paragraph 41BE(1)(e) of the Act, in relation to any of the following medical devices, a characteristic is the unique product identifier of the device: (a) a Class 4 IVD medical device, other than an immunohaematology reagent IVD medical device that is a Class 4 IVD medical device; (c) a Class III medical device; (d) an IVD companion diagnostic. #### 1.7 Device nomenclature system codes (Act s 41BE(3)) (1) In accordance with the Global Medical Device Nomenclature System Code, as set out in ISO 15225:2000(E), the device nomenclature system code specified for a medical device is: (a) for a Class 4 IVD medical device—the relevant preferred term; and (b) for a Class 4 IVD medical device that is an immunohaematology reagent IVD medical device—the relevant Level 2 collective term; and (c) for a Class 3 IVD medical device—the relevant Level 3 collective term, or if no Level 3 collective term exists, the relevant Level 2 collective term; and (d) for a Class 2 IVD medical device—the relevant Level 2 collective term; and (e) for a Class 1 IVD medical device or an export only IVD medical device—the relevant Level 1 collective term; and (f) for a Class III medical device, Class IIb medical device or Class IIa medical device—the relevant preferred term; and (g) for any of the following—the relevant preferred term: (i) a Class I medical device that the manufacturer intends to be supplied in a sterile state; (ii) a Class I medical device that has a measuring function; (iii) a Class I medical device for which there is no relevant template term; and (h) for any other Class I medical device—the relevant template term. (2) In this regulation: > collective term means a term that: (a) is used for those medical devices that share common features; and (b) is identified in the Global Medical Device Nomenclature System Code; and (c) is included in the document Collective terms available as device nomenclature system codes for IVD medical devices for the purposes of section 41BE(3) of the Act, published by the Therapeutic Goods Administration, as updated from time to time. Examples: > Note: Examples of the use of a collective term include the following: (a) to illustrate the scope of certificates issued by conformity assessment bodies when assessing which groups, families or types of medical devices are covered within a manufacturer’s quality system; (b) to identify the range of skills and general technological abilities for which a conformity assessment body has been approved and is so appointed by the relevant regulatory authority; (c) for the exchange of information between regulatory authorities when general information on individual manufacturers’ capabilities is notified. > ISO 15225:2000(E) means International Standard ISO 15225:2000(E) (Nomenclature—Specification for a nomenclature system for medical devices for the purposes of regulatory data exchange). > relevant preferred term, for a medical device, means the preferred term for that device under ISO 15225:2000(E). > relevant template term, for a medical device, means the template term for that device under ISO 15225:2000(E). #### 1.8 Classes of persons that are not manufacturers of a medical device For the purposes of subsection 41BG(4) of the Act, a class of persons is health professionals, or suitably qualified persons within a healthcare facility, who produce a medical device (the final device) where the following are satisfied: (a) a medical device production system is used to produce the final device; (b) the medical device production system is included in the Register as a kind of medical device. ## Part 2—Essential principles #### 2.1 Essential principles (Act s 41CA) For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1. ## Part 3—Conformity assessment procedures ### Division 3.1—Medical device classifications #### 3.1 Medical device classifications (Act s 41DB) (1) For section 41DB of the Act, the following table specifies the medical device classifications. ```html <table cellspacing="0" cellpadding="0" style="width:426.45pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:230.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Medical device classifications</td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"></td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"></td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"></td><td style="width:116.9pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 1</td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 2</td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 3</td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 4</td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 5</td></tr><tr><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Item</td><td style="width:116.9pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Medical device</td><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class</td><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class</td><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class</td><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class</td></tr></thead><tbody><tr><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1</td><td style="width:116.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Medical devices other than IVD medical devices</td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">I</td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">IIa</td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">IIb</td><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">III</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">2</td><td style="width:116.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">IVD medical devices and in‑house IVD medical devices</td><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1</td><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">2</td><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">3</td><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">4</td></tr></tbody></table> ``` (2) In the table: (a) the lowest level of medical device classification is specified in column 2; and (b) successively higher levels of classification are specified in columns 3 to 5; and (d) a device specified in a column has the same level of classification as any other device specified in that column. #### 3.2 Classification of medical devices (1) A medical device, other than an IVD medical device, has the medical device classification applying under the classification rules set out in Schedule 2. (2) An IVD medical device has the medical device classification applying under the classification rules set out in Schedule 2A. #### 3.3 Principles for applying the classification rules (1) For the purpose of classifying a medical device, the principles set out in this regulation apply. (2) A medical device is classified as follows: (a) if the medical device is a medical device other than an IVD medical device—having regard to the intended purpose of the device; (b) if the medical device is an IVD medical device or an in‑house IVD medical device—having regard to the intended purpose of the device in accordance with the following risk classes: (i) Class 1 IVD medical device or Class 1 in‑house IVD medical device—no public health risk or low personal risk; (ii) Class 2 IVD medical device or Class 2 in‑house IVD medical device—low public health risk or moderate personal risk; (iii) Class 3 IVD medical device or Class 3 in‑house IVD medical device—moderate public health risk or high personal risk; (iv) Class 4 IVD medical device or Class 4 in‑house IVD medical device—high public health risk. (3) If a medical device is designed to be used in combination with another medical device, each of the devices is classified separately. (4) An accessory to a medical device is classified separately from the medical device. (5) If a medical device is driven, or influenced, by an item of software, the software has the same classification as the medical device. (5A) A medical device production system has the same classification as the medical device the system is intended to produce. (6) If a medical device is not designed to be used solely or principally in a specific part of a patient’s body, the medical device is classified having regard to the most critical specified use of the medical device. (7) If, based on the intended purpose of the device, 2 or more classification rules apply to the medical device, the device has the highest level of classification applying under the applicable classification rules. (8) For classification of a medical device system or a medical device procedure pack, medicines are not considered to be integral to the system or the procedure pack. (9) For a system or procedure pack that contains both the devices mentioned in subregulation (11), that have different levels of classification under the table in regulation 3.1, the classification level of the system or procedure pack is that of the highest class of device mentioned in subregulation (11). (10) A system or procedure pack that contains both of the devices mentioned in subregulation (11), that have the same level of classification under the table in regulation 3.1, is classified according to its primary intended purpose. (11) For subregulations (9) and (10), the devices are: (a) an IVD medical device; and (b) a medical device that is not an IVD medical device. ### Division 3.2—Conformity assessment procedures #### 3.4 Conformity assessment procedures (Act s 41DA) (1) For section 41DA of the Act, the requirements relating to the obligations of manufacturers of medical devices (the conformity assessment procedures) are set out in Schedule 3. (2) The application of the conformity assessment procedures to a medical device, or a kind of medical device, is set out in this Division. (3) Subregulation (4) applies to the following devices: (a) Class IIb medical devices; (b) Class 3 IVD medical devices; (c) Class IIa medical devices; (d) Class 2 IVD medical devices; (e) Class I medical devices; (f) Class 1 IVD medical devices. (4) The manufacturer of a device mentioned in subregulation (3) must apply to the device appropriate conformity assessment procedures, being: (a) the minimum conformity assessment procedures that are applicable, under this Division, to the device; or (b) if the manufacturer prefers, conformity assessment procedures that are applicable, under this Division, to a medical device that is classified at a higher level than the device concerned. #### 3.5 Powers and functions of Secretary in relation to conformity assessment (1) For the purpose of applying conformity assessment procedures to a kind of medical device, a power or function of the Secretary, in relation to an assessment to be conducted under the procedures, may be exercised or performed at the place where the manufacturer is located, and at the manufacturing site, by a body or authority that the Secretary is satisfied has the authority and expertise to exercise that power or perform that function. (2) If, under the conformity assessment procedures, the manufacturer of the kind of medical device is required to give information of a kind mentioned in paragraph 41MP(2)(a) or (b) of the Act to the Secretary, the information must be given to the Secretary in addition to any such information that is given to the body or authority mentioned in subregulation (1). #### 3.6 Class III medical devices (other than medical devices used for a special purpose) (1) Subject to subregulation (2), the conformity assessment procedures that must be applied to a Class III medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers: (a) the full quality assurance procedures; or (b) the type examination procedures and: (i) the verification procedures; or (ii) the production quality assurance procedures. (2) If the device is intended by the manufacturer to be supplied in a sterile state, the conformity assessment procedures that must be applied to the device are, as the manufacturer prefers: (a) the full quality assurance procedures; or (b) the type examination procedures and the production quality assurance procedures. #### 3.6A Class 4 IVD medical devices (other than medical devices to be used for a special purpose) The conformity assessment procedures that must be applied to a Class 4 IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers: (a) the full quality assurance procedures; or (b) the type examination procedures and the production quality assurance procedures. #### 3.6B Class 4 in‑house IVD medical devices (other than medical devices to be used for a special purpose) The conformity assessment procedures that must be applied to a Class 4 in‑house IVD medical device (other than a medical device to be used for a special purpose) are, as the manufacturer prefers: (a) the full quality assurance procedures; or (b) the conformity assessment procedures set out in Part 6B of Schedule 3. #### 3.7 Class IIb medical devices (other than medical devices used for a special purpose) (1) Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIb medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers: (a) the full quality assurance procedures (other than clause 1.6); or (b) the type examination procedures and: (i) the verification procedures; or (ii) the production quality assurance procedures; or (iii) the product quality assurance procedures. (2) If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers: (a) the full quality assurance procedures (other than clause 1.6); or (b) the type examination procedures and the production quality assurance procedures. > Note: The manufacturer of a Class IIb medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3). #### 3.7A Class 3 IVD medical devices (other than devices to be used for a special purpose) The minimum conformity assessment procedures that must be applied to a Class 3 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers: (a) the full quality assurance procedures, other than clause 1.6 of Schedule 3; or (b) the type examination procedures and the production quality assurance procedures. > Note: The manufacturer of a Class 3 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3). #### 3.7B Class 3 in‑house IVD medical devices The conformity assessment procedures that must be applied to a Class 3 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3. #### 3.8 Class IIa medical devices (other than medical devices used for a special purpose) (1) Subject to subregulation (2), the minimum conformity assessment procedures that must be applied to a Class IIa medical device (other than a medical device used for a special purpose) are, as the manufacturer prefers: (a) the full quality assurance procedures (other than clause 1.6); or (b) the declaration of conformity (not requiring assessment by Secretary) procedures and: (i) the verification procedures (other than clause 3.5); or (ii) the production quality assurance procedures (other than clause 4.7); or (iii) the product quality assurance procedures (other than clause 5.7). (2) If the device is intended by the manufacturer to be supplied in a sterile state, the minimum conformity assessment procedures that must be applied to the device are, as the manufacturer prefers: (a) the full quality assurance procedures (other than clause 1.6); or (b) the production quality assurance procedures (other than clause 4.7) and the declaration of conformity (not requiring assessment by Secretary) procedures. > Note: The manufacturer of a Class IIa medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must or may be applied to a medical device that is classified at a higher level—see subregulation 3.4(3). #### 3.8A Class 2 IVD medical devices (other than devices to be used for a special purpose) The minimum conformity assessment procedures that must be applied to a Class 2 IVD medical device, other than a device to be used for a special purpose, are, as the manufacturer prefers: (a) the full quality assurance procedures, other than clause 1.6 of Schedule 3; or (b) the declaration of conformity (not requiring assessment by Secretary) procedures and the production quality assurance procedures, other than clause 4.7 of Schedule 3. > Note: The manufacturer of a Class 2 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3). #### 3.8B Class 2 in‑house IVD medical devices The conformity assessment procedures that must be applied to a Class 2 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3. #### 3.9 Class I medical devices (other than medical devices used for a special purpose) (1) Subject to subregulations (2) and (3), the minimum conformity assessment procedures that must be applied to a Class I medical device (other than a medical device used for a special purpose) are the declaration of conformity (not requiring assessment by Secretary) procedures. (2) If the device is intended by the manufacturer to be supplied in a sterile state, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures to the device, the production quality assurance procedures (other than clause 4.7) must also be applied to the device. (3) If the device has a measuring function, and the manufacturer applies the declaration of conformity (not requiring assessment by Secretary) procedures, one of the following sets of procedures, as the manufacturer prefers, must also be applied to the device: (a) the verification procedures (other than clause 3.5); (b) the production quality assurance procedures (other than clause 4.7); (c) the product quality assurance procedures (other than clause 5.7). > Note: The manufacturer of a Class I medical device (other than a medical device used for a special purpose) may prefer to apply to the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3). #### 3.9A Class 1 IVD medical devices (other than devices to be used for a special purpose) The minimum conformity assessment procedures that must be applied to a Class 1 IVD medical device, other than a device to be used for a special purpose, are the declaration of conformity (not requiring assessment by Secretary) procedures. > Note: The manufacturer of a Class 1 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3). #### 3.9B Class 1 in‑house IVD medical devices The conformity assessment procedures that must be applied to a Class 1 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3. #### 3.10 Medical devices used for a special purpose (1) This regulation applies to the following kinds of medical devices (medical devices used for a special purpose): (a) an exempt device; (b) a medical device that is the subject of an approval under section 41HB of the Act; (c) a medical device that is the subject of an authority under section 41HC of the Act; (d) a system or procedure pack to which subregulation (3) applies. > Note 1: An exempt device is a medical device of a kind that is exempted from the operation of Division 3 of Part 4‑11 of the Act by the regulations (see subsection 3(1) of the Act). Division 7.1 and Schedule 4 to these Regulations deal with exempt devices. > Note 2: For a system or procedure pack to which paragraph (1)(d) applies and that contains an IVD medical device and a medical device that is not an IVD medical device: (a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and (b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures for medical devices used for a special purpose in clause 7.5 of Schedule 3. > Note 3: For a system or procedure pack to which paragraph (1)(d) does not apply: (a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and (b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures that apply to the relevant classification. Exception (1A) However, paragraphs (1)(a), (b) and (c) do not apply to a Class 1 in‑house IVD medical device, a Class 2 in‑house IVD medical device or a Class 3 in‑house IVD medical device. > Note: The conformity assessment procedures that must be applied to Class 1 in‑house IVD medical devices, Class 2 in‑house IVD medical devices or Class 3 in‑house IVD medical devices are the procedures mentioned in Part 6A of Schedule 3. (2) The conformity assessment procedures that must be applied to a medical device used for a special purpose are the procedures for medical devices used for a special purpose. (3) This subregulation applies to a system or procedure pack: (a) where each medical device included in the system or procedure pack is a medical device to which the relevant conformity assessment procedures have been applied; and (aa) if one or more medicines, biologicals or other therapeutic goods are included in the system or procedure pack: (i) if all of those medicines and biologicals are entered on the Register; and (ii) if all of those other therapeutic goods are entered on the Register, or are covered by subregulation 12(1) of the Therapeutic Goods Regulations 1990 to the extent that they are tampons, menstrual cups or disinfectants; and (iii) if there has been no modification of the packaging of any of those medicines, biologicals or other therapeutic goods; and (iv) if there has been no modification of any of those medicines, biologicals or other therapeutic goods; and (b) that has been put together in accordance with the intended purpose of each medical device and the approved indications of each medicine, biological and other therapeutic goods; and (c) the contents of which are compatible, having regard to the intended purpose of each medical device, the approved indications of each medicine, biological or other therapeutic goods, and the intended purpose of the system or procedure pack. (4) If a system or procedure pack is intended by the manufacturer to be supplied in a sterile state: (a) the full quality assurance procedures (other than clause 1.6); or (b) the production quality assurance procedures (other than clause 4.7); must also be applied to the system or procedure pack in relation to the aspects of the manufacturing process that relate to ensuring that the system or procedure pack is supplied and maintained in a sterile state. > Note: If a medicine is included in the system or procedure pack, the manufacturer of the system or procedure pack must ensure that the method to be used for sterilisation or resterilisation is appropriate or is in accordance with the approved indications of the medicine. #### 3.11 Medical devices to which the clinical evaluation procedures must be applied (1) Subject to subregulation (2), in addition to the conformity assessment procedures that are applied to a medical device in accordance with another regulation in this Division, the clinical evaluation procedures must also be applied to the device, for the purpose of demonstrating that the device complies with the applicable provisions of the essential principles, in particular: (a) clause 1 of Schedule 1 (identification of the benefits and risks associated with the use of the device); and (b) clause 3 of Schedule 1 (use of the device for its intended purpose); and (c) clause 6 of Schedule 1 (acceptability of any side effects associated with the use of the device). (2) This regulation does not apply to any of the following: (a) an exempt device (other than an exempt device of a kind described in item 1.3 of Schedule 4); (b) a medical device that is the subject of an approval under section 41HB of the Act; (c) a medical device that is the subject of an authority under section 41HC of the Act. (3) Despite subregulation (2), this regulation applies to a custom‑made medical device. #### 3.12 Records to be provided in English All records (including correspondence) provided by the manufacturer of a medical device in relation to the application of the conformity assessment procedures to the device must be in English. #### 3.13 Assessment or verification at intermediate stage of manufacture (1) At the request of a person, and on payment of the prescribed fee, the Secretary may arrange for assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article that is intended to be used in the manufacture of a medical device. (2) A request may be made: (a) at any stage of the manufacturing process; and (b) whether or not an application has been made in relation to the article: (i) for a conformity assessment certificate in respect of a medical device; or (ii) for inclusion of a kind of medical device in the Register. ## Part 4—Conformity assessment certificates ### Division 4.1—Issuing conformity assessment certificates #### 4.2 Considering applications for conformity assessment certificates (Act s 41EC) For subsection 41EC(2) of the Act, the following other requirements of the conformity assessment procedures are specified: (a) the applicable requirements in relation to the establishment and maintenance of a post‑market monitoring, reporting and corrective action system; (b) the applicable requirements in relation to the keeping of records. #### 4.3 Time for making decision on applications (Act s 41ED, s 63(2)(dc)) (1) This regulation applies to an application for the issue of a conformity assessment certificate in respect of a kind of medical device if, in considering the application, the Secretary is required to examine the design of the device. (2) The Secretary must make a decision on the application within 255 working days after the application is received at an office of the Department specified by the Secretary. (3) For subregulation (2), a working day that occurs in any of the following periods is to be disregarded: (a) if the Secretary sends a query, or a request for information, to the applicant or sponsor—the period beginning on the day when the query or request is sent and ending at the end of the day when the Secretary receives from the applicant or sponsor a response that enables the Secretary to proceed with the assessment; (b) if an appeal is lodged in relation to the application—the period beginning on the day when the appeal is lodged and ending at the end of the day when the appeal is finally determined; (c) any other period in relation to which the applicant or sponsor agrees in writing for the purposes of this subregulation. ### Division 4.1A—Conformity assessment (priority applicant) determinations #### 4.3A Application of Division For the purposes of subsection 41ECA(1) of the Act, this Subdivision makes provision for and in relation to the making of conformity assessment (priority applicant) determinations. #### 4.3B Application for conformity assessment (priority applicant) determination (1) A person may apply to the Secretary for a conformity assessment (priority applicant) determination in relation to a medical device. (2) An application under subregulation (1) must: (a) be in writing; and (b) be in a form approved, in writing, by the Secretary; and (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered. (3) An application under subregulation (1) is taken not to have been made unless: (a) the application meets the requirements in subregulation (2); and (b) the fee prescribed in item 1.1A of Part 1 of Schedule 5 for making the application has been paid. #### 4.3C Making of conformity assessment (priority applicant) determination (1) On receiving an application under subregulation 4.3B(1) for a conformity assessment (priority applicant) determination in relation to a medical device, the Secretary must: (a) consider the application; and (b) decide either: (i) to make the determination; or (ii) to refuse to make the determination. Criteria (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device): (a) the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition; (b) either: (i) no medical devices with that intended purpose are of a kind included in the Register; or (ii) if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices)—there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices; (c) at least one of the following applies to the new device: (i) the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology; (ii) there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register; (iii) the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit. Information to be specified in determination (3) The determination must specify: (a) the person who, as a result of section 41ECA of the Act, is the priority applicant; and (b) the medical device to which the determination relates; and (c) the intended purpose of the medical device. Notification of decision (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision. (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision. #### 4.3D Period during which conformity assessment (priority applicant) determination is in force (1) A conformity assessment (priority applicant) determination in relation to a medical device: (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 4.3C(4); and (b) subject to subregulation (2) and regulation 4.3E, remains in force for 6 months. (2) If the priority applicant specified in the determination makes an effective application under section 41EB of the Act for a conformity assessment certificate that covers the medical device before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until: (a) the priority applicant withdraws the application; or (b) the application lapses in accordance with section 41EG of the Act; or (c) the application is finally determined. > Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective. #### 4.3E Revocation of conformity assessment (priority applicant) determination (1) The Secretary may revoke a conformity assessment (priority applicant) determination in relation to a medical device if: (a) either: (i) the priority applicant specified in the determination has not made an application under section 41EB of the Act for a conformity assessment certificate that covers the medical device; or (ii) the priority applicant has made such an application, but the application is not effective; and (b) the Secretary is satisfied that the criteria specified in subregulation 4.3C(2) are no longer satisfied in relation to the medical device. > Note: See subsection 41EB(2) of the Act for when an application under section 41EB of the Act is effective. (2) The revocation must be by written notice given by the Secretary to the priority applicant. ### Division 4.1B—Content of conformity assessment certificates #### 4.3F Content of conformity assessment certificates For the purposes of subsection 41EE(3) of the Act, the information is all of the following: (a) a unique identification number for the certificate; (b) the day on which the certificate is issued; (c) the name and address of the manufacturer of the medical devices; (d) the conformity assessment procedures applied to the medical devices by the manufacturer; (e) if the certificate covers a medical device to which paragraph 1.6(a), (b), (c) or (d) applies—the unique product identifier of the device; (f) the conditions to which the certificate is subject under section 41EJ or 41EK of the Act; (g) if one or more conformity assessment certificates have previously been issued in respect of the medical devices—the day on which each of those certificates was issued; (h) the signature and name of the person issuing the certificate. ### Division 4.1C—Conditions #### 4.3G Conditions applying automatically—information about poisons (1) This regulation applies to a conformity assessment certificate that covers a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard. (2) However, this regulation does not apply to the certificate if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device. (3) For the purposes of subsection 41EJ(5A) of the Act, the certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will not supply a medical device of that kind if the supply would contravene Part 2 of the current Poisons Standard. ### Division 4.2—Suspension of conformity assessment certificates #### 4.4 Period for revocation of suspension (Act s 41EP, s 63(2)(db)) (1) This regulation applies to an application to the Secretary under paragraph 41EP(2)(a) of the Act to revoke the suspension of a conformity assessment certificate. (2) The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary. ### Division 4.3—Transfer of conformity assessment certificates #### 4.5 Application of Division 4.3 This Division applies in relation to a manufacturer of a medical device in respect of whom a conformity assessment certificate is issued. #### 4.6 Death, bankruptcy or winding up of manufacturer (1) If the manufacturer dies, the manufacturer’s legal personal representative: (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and (b) must notify the Secretary, in writing, of the death not later than 3 months after it occurred. (2) If the manufacturer becomes bankrupt, the trustee in bankruptcy of the manufacturer’s estate: (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and (b) must notify the Secretary, in writing, of the manufacturer’s bankruptcy not later than 3 months after it occurred. (3) If the manufacturer is a body corporate that is wound up, the liquidator of the body corporate: (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and (b) must notify the Secretary, in writing, of the winding up of the body corporate not later than 3 months after it occurred. > Note: See also regulations 4.10 and 4.11. #### 4.7 Disposal of business or amalgamation with another manufacturer (1) This regulation applies if the name of the manufacturer is changed in any of the following circumstances: (a) the manufacturer agrees to dispose of a business concerned with the manufacture of the medical device, and it is agreed that the disposal is to include a transfer of the conformity assessment certificate issued in respect of the manufacturer and the medical device; (b) in the case of a manufacturer that is a body corporate—the manufacturer amalgamates with another body corporate under a name that is different from the name of the manufacturer on the conformity assessment certificate. (2) The person to whom the business is disposed of, or the body corporate with whom the manufacturer amalgamates: (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and (b) must, not later than 3 months after the disposal or amalgamation, apply to the Secretary, in writing, for the name of the manufacturer to be changed on the conformity assessment certificate. #### 4.8 Change of name of manufacturer If the name of the manufacturer is changed: (a) the manufacturer, as renamed, is taken to be the person in respect of whom the conformity assessment certificate is issued; and (b) the manufacturer must, not later than 3 months after the name is changed, notify the Secretary, in writing, of the new name and the circumstances in which the change occurred. > Note: See also regulations 4.10 and 4.11. #### 4.9 Effect of conformity assessment certificate after transfer, etc If a conformity assessment certificate is taken to be issued in respect of a person because of the operation of regulation 4.6, 4.7 or 4.8: (a) the certificate has effect as if it had actually been issued in respect of that person; and (b) the medical devices to which the certificate relates may continue to be manufactured while the certificate is in effect. #### 4.10 Notification to Secretary of events (1) If a person is required to notify the Secretary of an event under this Division, the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification. (2) If, at any time, the Secretary becomes aware that he or she has not been notified of an event as required by this Division, the Secretary may suspend or revoke the conformity assessment certificate to which the event relates. #### 4.11 Notification of change of name or suspension or revocation of conformity assessment certificate (1) If, under this Division, the Secretary: (a) changes the name of a manufacturer on a conformity assessment certificate; or (b) suspends or revokes a conformity assessment certificate issued in respect of a manufacturer; the Secretary must, as soon as practicable after changing the name or suspending or revoking the conformity assessment certificate: (c) notify the manufacturer that the name has been changed or the conformity assessment certificate has been suspended or revoked; and (d) ask the manufacturer to return to the Secretary the conformity assessment certificate that was given before the change of name or suspension or revocation. (2) If a manufacturer receives a notice under subregulation (1), the manufacturer must return to the Secretary, as soon as practicable after receiving the notice, the conformity assessment certificate that was given before the change of name or suspension or revocation. Penalty: 5 penalty units. (3) An offence against subregulation (2) is an offence of strict liability. > Note: For strict liability, see section 6.1 of the Criminal Code. ## Part 4A—Australian conformity assessment bodies ### Division 4A.1—Preliminary #### 4A.1 Purposes of this Part (1) This Part (other than Division 4A.7) is made for the purposes of section 41EWA of the Act (about Australian conformity assessment bodies). (2) Division 4A.7 is made for the purposes of section 41EWB of the Act (about the content of Australian conformity assessment body certificates). ### Division 4A.2—Making conformity assessment body determinations #### 4A.2 Applications (1) An Australian corporation may apply to the Secretary for a conformity assessment body determination in respect of the corporation. (2) The application must: (a) be made: (i) in writing; and (ii) in a form (if any) approved under subregulation (4); and (iii) in a manner (if any) approved under subregulation (4); and (b) be delivered to an office of the Department specified under subregulation (6). (3) The application is not effective if: (a) the application does not meet the requirements of subregulation (2) and regulation 4A.4; or (b) the application contains information that is false or misleading in a material particular; or (c) the application fee for the application has not been paid. > Note 1: For the application fee, see regulation 9.1 and Part 1 of Schedule 5. > Note 2: A conformity assessment body determination assessment fee is payable under Division 9.2 for assessment of the application. Forms and manners (4) For the purposes of subparagraph (2)(a)(ii) or (iii), the Secretary may, in writing, approve a form or manner for making an application for a conformity assessment body determination. (5) The Secretary may approve different forms and manners for different classes of conformity assessment body determinations. Offices (6) For the purposes of paragraph (2)(b), the Secretary may, in writing, specify an office of the Department to which applications for conformity assessment bodies must be delivered. (7) The Secretary may specify different offices for different classes of conformity assessment body determinations. #### 4A.3 Further information (1) For the purposes of assessing an application for a conformity assessment body determination, the Secretary may, by written notice given to the applicant, require the applicant to deliver specified information or documents: (a) to the office of the Department to which the application was delivered; and (b) within the period, of not less than 10 working days after the day the notice is given, specified in the notice; and (c) in a manner (if any) specified in the notice; and (d) in accordance with regulation 4A.4. (2) For the purposes of assessing an application for a conformity assessment body determination, the Secretary may: (a) by written notice given to the applicant, require the applicant to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the applicant to carry on certification‑related activities; or (b) by written notice given to a contractor of the applicant, require the contractor to allow an authorised person, at any reasonable time specified in the notice, to inspect specified premises (including premises outside Australia) that are or will be used by the contractor to carry on certification‑related activities for the applicant. > Note: For authorised person, see subsection 3(1) of the Act. (3) If the Secretary gives a notice to a contractor under paragraph (2)(b), the Secretary must give a copy of the notice to the applicant. #### 4A.4 Documents to be provided in English All documents (including correspondence) provided by an applicant in relation to an application for a conformity assessment body determination: (a) must be provided in English; and (b) may also be provided in any other language. #### 4A.5 Lapsing of applications An application for a conformity assessment body determination lapses if: (a) the applicant, or a contractor of the applicant, fails to comply with a notice under subregulation 4A.3(1) or (2) in relation to the application; or (b) information given to the Secretary by, or on behalf of, the applicant in connection with the application, including information given for the purposes of a notice under subregulation 4A.3(1), is false or misleading in a material particular; or (c) for the whole or a part of the conformity assessment body determination assessment fee for the application that is due and payable as mentioned in Division 9.2—the applicant fails to pay that whole or part in accordance with that Division. #### 4A.6 Assessing applications (1) If an application is made in accordance with regulation 4A.2 for a conformity assessment body determination in respect of an Australian corporation, the Secretary must decide whether to make the conformity assessment body determination. Conditions and criteria for making determinations (2) The Secretary must not decide to make the determination unless he or she is satisfied that it is likely that the Australian corporation will be able to comply with the requirements of Schedule 3AA. (3) In deciding whether to make the conformity assessment body determination, the Secretary must also consider: (a) whether at least one of the following persons: (i) the Australian corporation; (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the Australian corporation’s affairs; (iii) a major interest holder of the Australian corporation; has, within the 10 years immediately before the application: (iv) been convicted of an offence against the Act or a corresponding State law; or (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (viii) breached a condition of a conformity assessment body determination; or (ix) had a conformity assessment body determination in respect of the person suspended or revoked; or (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies in that 10 years, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate; and (b) any other relevant matter. (4) A reference in paragraph (3)(a) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under: (a) section 19B of the Crimes Act 1914; or (b) a corresponding provision of a law of a State or Territory. > Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction. (5) Nothing in this regulation affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them). (6) Subregulation (2) and paragraph (3)(a) do not limit paragraph (3)(b). #### 4A.7 Procedure following decisions to make determinations (1) This regulation applies if the Secretary decides under subregulation 4A.6(1) to make a conformity assessment body determination in respect of an Australian corporation. (2) The Secretary must notify the Australian corporation within 20 working days. (3) When all conformity assessment body determination assessment fees that are due and payable for the application have been paid, the Secretary must: (a) make the determination, including specifying: (i) the scope of the determination in accordance with subregulation (4); and (ii) the commencement and duration of the determination in accordance with regulation 4A.8; and (b) give it to the corporation. (4) The conformity assessment body determination must specify whether it: (a) is of general application; or (b) is limited to either or both of the following: (i) one or more specified medical devices; (ii) one or more specified conformity assessment procedures. (5) The conformity assessment body determination may specify conditions to which it is subject. > Note: See regulation 4A.19. #### 4A.8 Duration of determinations (1) A conformity assessment body determination commences on the day specified for the purpose in the determination under subparagraph 4A.7(3)(a)(ii). (2) A conformity assessment body determination has effect at all times: (a) unless the determination is suspended under Division 4A.4; or (b) until the end of the period specified in the determination under subparagraph 4A.7(3)(a)(ii); or (c) until the determination is revoked under Division 4A.5. (3) The period specified in the determination as mentioned in paragraph (2)(b) must be 5 years or less, starting on the day the determination commences. #### 4A.9 Procedure following decisions not to make determinations (1) This regulation applies if the Secretary decides under subregulation 4A.6(1) not to make a conformity assessment body determination in respect of an Australian corporation. (2) The Secretary must notify the Australian corporation within 20 working days. (3) The notice must state the reasons for the decision. ### Division 4A.3—Conditions on conformity assessment body determinations #### Subdivision A—Automatic conditions on determinations #### 4A.10 Automatic conditions on determinations A conformity assessment body determination is subject to the conditions set out in this Subdivision. > Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination. #### 4A.11 Conditions—requirements of Schedule 3AA The Australian conformity assessment body will comply with the requirements of Schedule 3AA. #### 4A.12 Conditions—notifying Secretary and clients (1) The Australian conformity assessment body will notify the Secretary within 10 working days if there are any substantial changes relating to the body’s compliance with the requirements of Schedule 3AA. (2) The Australian conformity assessment body will notify the Secretary and relevant clients of the body as soon as practicable if the body plans to cease carrying on one or more kinds of certification‑related activities relating to conformity assessment procedures covered by the determination. (3) The notice under subregulation (2) must specify the day on which the body plans to cease carrying on the activity. #### 4A.13 Conditions—entry and inspection (1) The Australian conformity assessment body will allow an authorised person: (a) to enter, at any reasonable time, premises used by the body to carry on certification‑related activities; and (b) while on those premises, to inspect those premises and anything on those premises that concerns certification‑related activities carried on by the body; and (c) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns certification‑related activities carried on by the body; and (d) while on those premises, to inspect, and make copies of, any documents that concern certification‑related activities carried on by the body. (2) The Australian conformity assessment body will have procedures, including a written agreement, in place with each contractor of the body that carries on certification‑related activities for the body that require the contractor to allow an authorised person: (a) to enter, at any reasonable time, premises used by the contractor to carry on those certification‑related activities; and (b) while on those premises, to inspect those premises and anything on those premises that concerns those certification‑related activities; and (c) while on those premises, to make any still or moving image or any recording of those premises or anything on those premises that concerns those certification‑related activities; and (d) while on those premises, to inspect, and make copies of, any documents that concern those certification‑related activities. #### 4A.14 Conditions—producing information and documents (1) The Australian conformity assessment body will, if requested to do so by the Secretary, give the Secretary information, or produce to the Secretary documents, that concern certification‑related activities carried on by the body. (2) The information will be given, or the documents produced, within the period, of not less than 20 working days after the day the notice is given, specified in the notice. (3) The Australian conformity assessment body will have procedures, including a written agreement, in place with each of: (a) its clients; and (b) the contractors of the body that carry on certification‑related activities for the body; that require the client or contractor to make available information or documents that the client or contractor has that is requested under subregulation (1). #### 4A.15 Conditions—reviews The Australian conformity assessment body will cooperate in any review by the Secretary of: (a) certification‑related activities carried on by the body; or (b) compliance with the conditions of the conformity assessment body determination. #### 4A.16 Conditions—record keeping The Australian conformity assessment body will keep: (a) the records required by Schedule 3AA; and (b) any other records necessary to demonstrate the body’s compliance, at all times while the determination is in effect, with the requirements of that Schedule. #### 4A.17 Conditions—Australian conformity assessment body certificates Conformity assessment procedures (1) The Australian conformity assessment body will not issue an Australian conformity assessment body certificate unless the body is satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate. Varying, suspending and revoking certificates (2) If the Australian conformity assessment body: (a) issues an Australian conformity assessment body certificate to a manufacturer; and (b) ceases to be satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate; the body will: (c) vary, suspend or revoke the certificate; or (d) give to the manufacturer a written notice stating that the body will vary, suspend or revoke the certificate if the manufacturer does not, within a specified period, take the action necessary to satisfy the body that an appropriate conformity assessment procedure has been applied to the devices. (3) A period specified in a notice under paragraph (2)(d) must be appropriate. (4) The Australian conformity assessment body will vary, suspend or revoke an Australian conformity assessment body certificate if: (a) the body gave a notice to a manufacturer under paragraph (2)(d) in relation to the certificate; and (b) at the end of the period specified in the notice, the body is not satisfied that an appropriate conformity assessment procedure has been applied to medical devices of the kind covered by the certificate. Notifying Secretary of changes to certificates and other matters (5) The Australian conformity assessment body will notify the Secretary within 10 working days if the body: (a) decides not to issue an Australian conformity assessment body certificate because the body is not satisfied as mentioned in subregulation (1); or (b) suspends or revokes an Australian conformity assessment body certificate; or (c) varies an Australian conformity assessment body certificate in the circumstances mentioned in subregulation (2) or (4); or (d) becomes aware of a matter of significant concern relating to the safety of a medical device to which an Australian conformity assessment body certificate issued by the body applies. #### 4A.18 Conditions—clients Notifying clients if determination varied or suspended (1) The Australian conformity assessment body will notify its clients within 10 working days if the conformity assessment body determination is varied or suspended. Agreements with successor Australian conformity assessment bodies (2) If a client of the Australian conformity assessment body (the old body) informs the old body that the client plans: (a) to cease to be a client of the old body; and (b) to become a client of another Australian conformity assessment body (the new body); the old body will enter into an agreement with the new body that deals appropriately with the transfer from the old body to the new body of responsibility for carrying on certification‑related activities for the client. Enquiries before accepting applications for certification (3) Before the Australian conformity assessment body accepts an application from a manufacturer to issue an Australian conformity assessment body certificate in relation to a kind of medical device, the body will make reasonable enquiries as to whether the manufacturer has applied to another Australian conformity assessment body to issue an Australian conformity assessment body certificate in relation to that kind of device. #### Subdivision B—Conditions specified in conformity assessment body determinations #### 4A.19 Conditions specified in determinations (1) A conformity assessment body determination is subject to any conditions specified in the determination under subregulation 4A.7(5) or 4A.28(1). > Note: See sections 41MN and 41MNA of the Act for offences and civil penalty provisions that apply to breaching a condition of a conformity assessment body determination. (2) A condition imposed under subregulation 4A.7(5) or 4A.28(1) is in addition to the conditions imposed under Subdivision A of this Division. ### Division 4A.4—Suspension of conformity assessment body determinations #### 4A.20 Suspension of determinations (1) The Secretary may, by written notice given to an Australian conformity assessment body, suspend the body’s conformity assessment body determination if the Secretary is satisfied that: (a) it is likely that there are grounds for revoking the determination under regulation 4A.27; and (b) it is likely that the body will, within the period of the suspension, be able to take action such that it will no longer be likely that there are grounds for revoking the determination. (2) The notice must specify the period of the suspension. The period: (a) must not exceed 12 months; and (b) must not begin before the notice is given to the body. > Note: The period of the suspension may be extended once under regulation 4A.22. #### 4A.21 Notice of proposed suspension (1) However, before suspending a conformity assessment body determination, the Secretary must: (a) notify the Australian conformity assessment body in writing that the Secretary proposes the suspension and set out the reasons for it; and (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension. (2) The Secretary must not make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the body makes under paragraph (1)(b). #### 4A.22 Duration of suspension (1) The suspension takes effect on the day specified for the purpose in the notice, which must be at least 20 working days after the notice is given to the Australian conformity assessment body. (2) The suspension has effect until: (a) the Secretary revokes it under regulation 4A.23; or (b) the end of: (i) the period specified in the notice under subregulation 4A.20(2); or (ii) if the period is extended under subregulation (3) of this regulation—the period as so extended. > Note 1: The conditions to which the determination is subject continue during the suspension: see subsection 41EWA(7A) of the Act. > Note 2: Unless a suspension of a conformity assessment body determination has been revoked, the determination is automatically revoked at the end of the period of the suspension: see regulation 4A.25. (3) The Secretary may, by written notice given to the body, extend the period specified in the notice under subregulation 4A.20(2) by a further specified period not exceeding 12 months if the Australian conformity assessment body shows that it has taken steps to address the grounds for revoking the determination under regulation 4A.27. (4) Only one extension of the period of the suspension may be made. #### 4A.23 Revocation of suspension (1) The Secretary must revoke the suspension if the Secretary is satisfied that: (a) the grounds on which the conformity assessment body determination was suspended no longer apply; and (b) there are no other grounds for suspending the determination. (2) The Secretary’s power to revoke the suspension may be exercised: (a) if the Australian conformity assessment body applies in writing to the Secretary; or (b) on the Secretary’s own initiative. (3) After revoking the suspension, the Secretary must, within 20 working days after the revocation, give written notice of the revocation to the Australian conformity assessment body. (4) If the Secretary decides, after an application is made under paragraph (2)(a), not to revoke the suspension, the Secretary must: (a) notify the applicant in writing of his or her decision within 20 working days after the decision is made; and (b) state in the notice the reasons for the decision. #### 4A.24 Powers of revocation of determinations unaffected (1) This Division does not affect the Secretary’s powers to revoke a conformity assessment body determination under Division 4A.5. (2) To the extent that a suspension under this Division relates to a conformity assessment body determination to which such a revocation relates, the suspension ceases to have effect. ### Division 4A.5—Revocation of conformity assessment body determinations #### 4A.25 Automatic revocation of determinations (1) The Secretary must, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if: (a) the determination has been suspended under Division 4A.4; and (b) the period of the suspension under paragraph 4A.22(2)(b) ends before the suspension is revoked under regulation 4A.23. (2) The revocation takes effect at the end of the period mentioned in paragraph (1)(b) of this regulation. #### 4A.26 Immediate revocation of determinations (1) The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if: (a) the body applies in writing to the Secretary; or (b) the body notifies the Secretary, as mentioned in subregulation 4A.12(2), that the body plans to cease carrying on certification‑related activities completely. (2) The revocation takes effect on the day specified for the purpose in the notice given by the Secretary. (3) If paragraph (1)(b) applies, the day specified in the notice given by the Secretary must be the day the Australian conformity assessment body notified the Secretary was the day the body planned to cease carrying on certification‑related activities. #### 4A.27 Revocation of determinations after notice of proposed revocation (1) The Secretary may, by written notice given to an Australian conformity assessment body, revoke the body’s conformity assessment body determination if: (a) the body refuses or fails to comply with a condition to which the determination is subject; or (b) at least one of the following persons: (i) the body; (ii) a person (a manager) who makes, or participates in making, decisions that affect the whole, or a substantial part, of the body’s affairs; (iii) a major interest holder of the body; has: (iv) been convicted of an offence against the Act or a corresponding State law; or (v) been convicted of an offence against a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (vi) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of the Act or a corresponding State law; or (vii) been ordered to pay a pecuniary penalty for the contravention of a civil penalty provision of a law of the Commonwealth or a law of a State or Territory involving fraud or dishonesty; or (viii) breached a condition of a conformity assessment body determination; or (ix) had a conformity assessment body determination in respect of the person suspended or revoked; or (x) been a manager, or a major interest holder, of a body corporate in respect of which subparagraph (iv), (v), (vi), (vii), (viii) or (ix) applies, if the conduct resulting in that subparagraph applying occurred when the person was a manager or major interest holder of the body corporate. (2) A reference in paragraph (1)(b) to a person convicted of an offence includes a reference to a person in respect of whom an order has been made relating to the offence under: (a) section 19B of the Crimes Act 1914; or (b) a corresponding provision of a law of a State or Territory. > Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction. (3) Nothing in this regulation affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them). Notice of proposed revocation (4) Before revoking a conformity assessment body determination under this regulation, the Secretary must: (a) notify the Australian conformity assessment body in writing that the Secretary proposes the revocation and set out the reasons for it; and (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed revocation. (5) The Secretary must not make a decision relating to the proposed revocation until the Secretary has had regard to any submissions the body makes under paragraph (4)(b). When revocation takes effect (6) A revocation under this regulation takes effect on the day specified for the purpose in the notice given to the Australian conformity assessment body under subregulation (1). (7) The day specified must not be earlier than the day the notice is given to the body. ### Division 4A.6—Variation of conformity assessment body determinations #### 4A.28 Imposing, varying or removing conditions (1) The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to: (a) impose new conditions on the determination; or (b) vary or remove existing conditions imposed on the determination under subregulation 4A.7(5) or this regulation. (2) The Secretary’s power under subregulation (1) may be exercised: (a) if the Australian conformity assessment body applies in writing to the Secretary; or (b) on the Secretary’s own initiative. When imposition, variation or removal takes effect (3) An imposition or variation of a condition under this regulation takes effect on the day specified for the purpose in the notice. (4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body: (a) applied for the imposition or variation; and (b) has agreed to an earlier day. (5) A removal of a condition under this regulation takes effect on the day specified in the notice. (6) The day specified in the notice under subregulation (5) must be at least 20 working days after the notice is given to the body, unless the body has agreed to an earlier day. (7) For the purposes of subregulations (4) and (6), the earlier day must not be earlier than the day the notice is given to the body. #### 4A.29 Limiting determinations (1) The Secretary may, by written notice given to an Australian conformity assessment body, vary the body’s conformity assessment body determination to limit, or further limit, the determination as mentioned in paragraph 4A.7(4)(b). (2) The Secretary’s power under subregulation (1) of this regulation may be exercised: (a) if the Australian conformity assessment body applies in writing to the Secretary; or (b) on the Secretary’s own initiative. (3) A variation under this regulation takes effect on the day specified for the purpose in the notice. (4) The day specified in the notice under subregulation (3) must be at least 20 working days after the notice is given to the body, unless the body: (a) applied for the variation; and (b) has agreed to an earlier day. (5) For the purposes of subregulation (4), the earlier day must not be earlier than the day the notice is given to the body. #### 4A.30 Notice of proposed variation (1) Before varying a conformity assessment body determination under this Division, the Secretary must: (a) notify the Australian conformity assessment body in writing that the Secretary proposes the variation and set out the reasons for it; and (b) give the body a reasonable opportunity to make submissions to the Secretary in relation to the proposed variation. (2) The Secretary must not make a decision relating to the proposed variation until the Secretary has had regard to any submissions the body makes under paragraph (1)(b). (3) This regulation does not apply if the body applied for the variation. ### Division 4A.7—Australian conformity assessment body certificates #### 4A.31 Content of Australian conformity assessment body certificates For the purposes of subsection 41EWB(2) of the Act, the information is all of the following: (a) the name and address of the body issuing the certificate; (b) the body’s ACN (within the meaning of the Corporations Act 2001); (c) the unique identification number assigned to the body under subsection 41EWA(4A) of the Act; (d) a unique identification number for the certificate; (e) the day on which the certificate is issued; (f) the name and address of the manufacturer of the medical devices; (g) the conformity assessment procedures applied to the medical devices by the manufacturer; (h) if the certificate covers a medical device to which paragraph 1.6(a), (b), (c) or (d) applies—the unique product identifier of the device; (i) if the certificate is varied—the day and details of the variation; (j) if one or more Australian conformity assessment body certificates have previously been issued in respect of the medical devices by the body—the information covered by paragraphs (a) to (i) in relation to each of those certificates. ## Part 5—Including medical devices in the Register ### Division 5.1—Including medical devices in the Register > Note: Regulation 5.1 is intentionally not used. #### Subdivision A—Applications #### 5.2 Matters to be certified—period for obtaining information from manufacturer (Act s 41FD) For subparagraphs 41FD(e)(ii) and (g)(ii) of the Act, the period is 20 working days. #### Subdivision C—Auditing of applications #### 5.3 Selecting applications for auditing (Act s 41FH) (1) For the purposes of paragraph 41FH(1)(a) of the Act, and subject to this regulation, an application for any of the following kinds of medical devices to be included in the Register is prescribed: (a) a Class III medical device; (b) any of the following IVD medical devices: (i) a Class 3 IVD medical device; (ii) a Class 4 IVD medical device; (iii) a Class 4 in‑house IVD medical device; (iv) an IVD medical device that is intended for self‑testing; (v) an IVD medical device that is intended for point of care testing. (2) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if a conformity assessment certificate, or an Australian conformity assessment body certificate, has been issued, and has not been suspended or revoked, in respect of the kind of medical device. (2AA) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if: (a) an overseas regulator conformity assessment document has been issued, in respect of the kind of medical device, by a notified body (within the meaning of the Therapeutic Goods (Overseas Regulators) Determination 2018) in accordance with: (i) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force from time to time; or (ii) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, as in force from time to time; and (b) the overseas regulator conformity assessment document has not been suspended or revoked. (2AB) Subregulation (1) does not apply to an application for a kind of medical device to be included in the Register if: (a) the kind of medical device: (i) is the subject of a medical device licence issued by Health Canada under the Medical Devices Regulations (Canada); or (ii) is the subject of an order approving an application for premarket approval from the US Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (United States of America); or (iii) is the subject of a pre‑market certification or approval issued by the Japanese Ministry of Health, Labour and Welfare, or the Japanese Pharmaceuticals and Medical Devices Agency, under The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Japan); or (iv) is the subject of an entry in the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under the Health Products Act 2007 (Singapore); or (v) has been certified in accordance with the Australia‑UK Mutual Recognition Agreement, the EC Mutual Recognition Agreement or the EFTA Mutual Recognition Agreement; and (b) the licence, order, approval, certification or entry has not: (i) been suspended, revoked or restricted (however described); or (ii) otherwise ceased to be in effect. (2A) Subregulation (1) does not apply to an application for a medical device that is covered by clause 5.8 of Schedule 2 or clause 1.8 of Schedule 2A. #### Subdivision D—Miscellaneous—medical devices (priority applicant) determinations #### 5.4 Application of Subdivision For the purposes of subsection 41FKA(1) of the Act, this Subdivision makes provision for and in relation to the making of medical devices (priority applicant) determinations. #### 5.4A Application for medical devices (priority applicant) determination (1) A person may apply to the Secretary for a medical devices (priority applicant) determination in relation to a medical device. (2) An application under subregulation (1) must: (a) be in writing; and (b) be in a form approved, in writing, by the Secretary; and (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered. (3) An application under subregulation (1) is taken not to have been made unless: (a) the application meets the requirements in subregulation (2); and (b) the fee prescribed in item 1.5A of Part 1 of Schedule 5 for making the application has been paid. #### 5.4B Making of medical devices (priority applicant) determination (1) On receiving an application under subregulation 5.4A(1) for a medical devices (priority applicant) determination in relation to a medical device, the Secretary must: (a) consider the application; and (b) decide either: (i) to make the determination; or (ii) to refuse to make the determination. Criteria (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medical device (the new device): (a) the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition; (b) either: (i) no medical devices with that intended purpose are of a kind included in the Register; or (ii) if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices)—there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices; (c) at least one of the following applies to the new device: (i) the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology; (ii) there is evidence that the new device offers a major clinical advantage over existing alternatives included in the Register; (iii) the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit. Information to be specified in determination (3) The determination must specify: (a) the person who, as a result of section 41FKA of the Act, is the priority applicant; and (b) the medical device to which the determination relates; and (c) the intended purpose of the medical device. Notification of decision (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision. (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision. #### 5.4C Period during which medical devices (priority applicant) determination is in force (1) A medical devices (priority applicant) determination in relation to a medical device: (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 5.4B(4); and (b) subject to subregulation (2) and regulation 5.4D, remains in force for 6 months. (2) If the priority applicant specified in the determination makes an application under section 41FC of the Act for that kind of medical device to be included in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until: (a) the priority applicant withdraws the application; or (b) the application lapses in accordance with section 41FK of the Act; or (c) the application is finally determined. > Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment. #### 5.4D Revocation of medical devices (priority applicant) determination (1) The Secretary may revoke a medical devices (priority applicant) determination in relation to a medical device if: (a) either: (i) the priority applicant specified in the determination has not made an application under section 41FC of the Act for that kind of medical device to be included in the Register; or (ii) the priority applicant has made such an application, but the application does not pass preliminary assessment; and (b) the Secretary is satisfied that the criteria specified in subregulation 5.4B(2) are no longer satisfied in relation to the medical device. > Note: See subsection 41FDB(3) of the Act for when an application passes preliminary assessment. (2) The revocation must be by written notice given by the Secretary to the priority applicant. ### Division 5.2—Conditions > Note: Regulation 5.5 is intentionally not used. #### 5.7 Conditions applying automatically—period for giving information about adverse events etc (Act s 41FN) (1) For paragraph 41FN(3)(d) of the Act, the period in which a person in relation to whom a kind of medical device is included in the Register must give information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act to the Secretary is: (a) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the person becomes aware of the event or occurrence; and (b) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—10 days after the person becomes aware of the event or occurrence; and (c) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—30 days after the person becomes aware of the event or occurrence; and (d) in any other case—60 days after the person becomes aware of the information. > Note: See also regulation 5.8A (which deals with the giving of a report after information is given within a period covered by paragraph (1)(a), (b) or (c) of this regulation). (2) For paragraph (1)(a), an event or other occurrence, in relation to a kind of medical device, represents a serious threat to public health if: (a) the event or other occurrence is a hazard arising from a systematic failure of the device that becomes known to the person in relation to whom the device is included in the Register; and (b) the event or other occurrence may lead to the death of, or a serious injury to, a patient, a user of the device or another person; and (c) the existence of, probable rate of occurrence of, or degree of severity of harm caused by, the hazard was not previously known or anticipated by the manufacturer of the device; and (d) the manufacturer will be required to take prompt action to eliminate, or reduce the risk of, the hazard. (3) For paragraphs (1)(b) and (c), an event or other occurrence leads to a serious deterioration in the state of health of a person if the event or other occurrence causes, or contributes to: (a) a life‑threatening illness or injury suffered by the person; or (b) a permanent impairment of a bodily function of the person; or (c) permanent damage to a body structure of the person; or (d) a condition requiring medical or surgical intervention to prevent such permanent impairment or damage. #### 5.8 Conditions applying automatically—requirements in relation to information about kind of medical device (Act s 41FN) For subsection 41FN(4) of the Act, the information required for the purposes of paragraph 41FN(3)(e) of the Act in relation to a kind of medical device that is included in the Register in relation to a person is: (a) any information that the person is aware of relating to: (i) any malfunction or deterioration in the characteristics or performance of the kind of device; or (ii) any inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the kind of device; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device; that has led to any complaint or problem in relation to the kind of device, no matter how minor; and (b) any information of the kind mentioned in subsection 41MP(2) of the Act that the person is aware of in relation to the kind of device. #### 5.8A Conditions applying automatically—giving of report about adverse events or occurrences (Act s 41FN) (1) For the purposes of subsection 41FN(5A) of the Act, if the person in relation to whom a kind of medical device is included in the Register gives information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act to the Secretary within the period covered by paragraph 5.7(1)(a), (b) or (c) of these Regulations, the person must give a written report to the Secretary in accordance with this regulation. (2) The person must give the report to the Secretary before the end of the period of 120 days beginning on the day the person gave that information to the Secretary. (3) The report must: (a) deal with any updates to that information since that information was given; and (b) set out details of the action the person has taken, or the manufacturer of the kind of medical device has taken, to investigate the event or other occurrence concerned; and (c) set out details of the action the person has taken, or the manufacturer of the kind of medical device has taken, to alleviate the impact of the event or other occurrence concerned for patients or for users of the kind of medical device; and (d) set out details of similar events or occurrences that have occurred in the last 3 years, in relation to the kind of medical device, of which the person is aware. #### 5.9 Conditions applying automatically—storage and transport of medical devices (Act s 41FN) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must ensure that, while the person has control over a device of that kind, the device is stored and transported in accordance with the manufacturer’s instructions for use of the device and any other information provided with the device by the manufacturer. #### 5.10 Conditions applying automatically—record‑keeping (Act s 41FN) (1) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a kind of medical device is included in the Register must: (a) create a record of information of a kind referred to in regulation 5.8 that relates to that kind of device as soon as practicable after the person becomes aware of the information; and (b) create a record of information in relation to the distribution by the person of each device of that kind as soon as practicable after the distribution. (2) A record created under subregulation (1) must be kept: (a) for 10 years if the record relates to one of the following kinds of device: (ii) a Class III medical device; (iii) a Class IIb medical device that is an implantable medical device; (iv) a Class 4 IVD medical device; or (b) for 5 years if the record relates to any other kind of device. #### 5.11 Conditions applying automatically—reporting (Act s 41FN) (1) This regulation applies in relation to the following kinds of medical devices: (b) a Class III medical device; (c) a Class IIb medical device that is an implantable medical device; (d) a Class 4 IVD medical device. (2) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must, before 1 October after each reporting period for that kind of device, give the Secretary a report about that kind of device for the reporting period. (3) The report must include the following: (a) if no device of that kind was supplied in Australia or a foreign country during the reporting period—a statement to that effect; (b) if the person became aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device—that information; (c) if the person did not become aware during the reporting period of information of a kind referred to in regulation 5.8 that relates to that kind of device—a statement to that effect. (4) For the purposes of this regulation, each of the following is a reporting period for a kind of medical device: (a) the period: (i) beginning on the day when that kind of device is included in the Register; and (ii) ending at the end of the next 30 June; (b) each of the next 2 financial years. (5) If: (a) on a day on or after 25 November 2021 medical devices of a kind (the current kind of medical device) referred to in a particular paragraph of subregulation (1) are included in the Register because of the amendments made by the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019; and (b) immediately before that day, those devices were of a kind (the previous kind of medical device) referred to in a different paragraph of subregulation (1) and were included in the Register; then subparagraph (4)(a)(i) applies in relation to the current kind of medical device as if the day when the current kind of medical device is included in the Register were the day when the previous kind of medical device was included in the Register. #### 5.12 Conditions applying automatically—notification of information (Act s 41FN) (1) This regulation applies in relation to the following kinds of medical devices: (a) a Class 3 IVD medical device; (b) a Class 4 IVD medical device; (c) a Class 4 in‑house IVD medical device; (d) an IVD medical device that is intended for self‑testing; (e) an IVD medical device that is intended for point of care testing; (f) a spinal fusion implantable device. > Note: For the purposes of paragraph (f), examples of spinal fusion implantable devices include screws, cages, plates, hooks or rods that are intended to be used during spinal fusion surgical procedures. (2) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must give the Secretary a written notice if: (a) the person intends to import, supply or export a medical device of that kind; and (b) either of the following is not included in the Register: (i) the product name of the device; (ii) information in relation to the manufacturer’s intended purpose of the device. (3) The notice must: (a) specify the information mentioned in paragraph (2)(b) that is not included in the Register; and (b) be given to the Secretary no later than 20 business days before the intended import, supply or export of the device. #### 5.13 Conditions applying automatically—information about poisons (Act s 41FN) (1) This regulation applies in relation to a kind of medical device that contains a substance of a kind covered by an entry in a Schedule to the current Poisons Standard. (2) However, this regulation does not apply in relation to that kind of medical device if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of medical device. (3) For the purposes of subsection 41FN(5A) of the Act, the person in relation to whom a medical device of that kind is included in the Register must not supply the device in Australia if the supply would contravene Part 2 of the current Poisons Standard. ## Part 6—Suspension and cancellation from the Register #### 6.1 Period for revocation of suspension (Act s 41GD, s 63(2)(dd)) (1) This regulation applies to an application to the Secretary under paragraph 41GD(2)(a) of the Act to revoke the suspension of a kind of medical device from the Register. (2) The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary. ## Part 6A—Disposal of unused emergency medical devices #### 6A.1 Disposal of unused emergency medical devices (1) For subsection 41GY(2) of the Act, the arrangements for disposal of unused emergency medical devices are set out in Schedule 3A. (2) Nothing in this regulation or in Schedule 3A is taken to prevent a disposal of unused emergency medical devices if: (a) the devices have become: (i) devices of a kind included in the Register under Part 4‑5 of the Act; or (ii) exempt devices under section 41HA of the Act; or (iii) devices that are the subject of an approval under section 41HB of the Act; or (iv) devices that are the subject of an authority under section 41HC of the Act; and (b) the disposal is in accordance with other provisions of the Act and these Regulations relevant to the devices. ## Part 7—Exempting medical devices from inclusion in the Register ### Division 7.1—Exempt devices #### 7.1 Exempt devices—general (Act s 41HA) (1) For paragraph 41HA(1)(b) of the Act, a kind of medical device mentioned in Part 1 of Schedule 4 is exempt from the operation of Division 3 of Part 4‑11 of the Act. (2) For paragraph 41HA(1)(b) and subsection 41HA(2) of the Act, a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 is exempt from the operation of Division 3 of Part 4‑11 of the Act, subject to compliance with the conditions mentioned in column 3 of that item. (3) If: (a) a kind of medical device that is exempt from the operation of Division 3 of Part 4‑11 of the Act ceases to be so exempt; and (b) an application was made for the kind of device to be included in the Register before the device ceased to be exempt; the kind of device is taken to be exempt from the operation of Division 3 of Part 4‑11 of the Act until the application is determined. Limited exemptions (8) For a kind of medical device that is exempt under item 1.7 of the table in Part 1 of Schedule 4, the exemption, to the extent that it relates to a particular manufacturer of a patient‑matched medical device, is subject to the condition that the exemption only has effect in relation to the first 5 patient‑matched medical devices manufactured by the manufacturer in a financial year. #### 7.2 Exempt devices—use in life‑threatening cases (Act s 41HA) (1) For paragraph 41HA(1)(b) of the Act, and without limiting regulation 7.1, a kind of medical device is exempt from the operation of Division 3 of Part 4‑11 of the Act if: (a) the kind of device is to be used in or on a person who is a Category A patient; and (b) the following conditions are satisfied in relation to the use of the device: (i) the person in or on whom the kind of device is to be used, or the person’s guardian, has given informed consent to the use of the device in or on the person; (ii) a statement in relation to the person is completed in accordance with subregulation (1A); (iii) the device is used in accordance with the direction of the medical practitioner who requested its use. (1A) For the purposes of subparagraph (1)(b)(ii), a statement in relation to the use of an exempt device in or on a person who is a Category A patient must: (a) be completed by: (i) the medical practitioner by whom, or at whose direction, the device is used; or (ii) by a health practitioner acting on behalf of that medical practitioner; and (b) be in the form approved by the Secretary for the purposes of this paragraph; and (c) include the following: (i) the initial letters of the person’s given name and surname, and the person’s date of birth and sex; (ii) the diagnosis of the person’s condition; (iii) the expected duration of the treatment; (iv) a description of the exempt device; (v) the supplier of the exempt device; (vi) the number of units of the exempt device to be supplied; (vii) the treating medical practitioner’s name, practising address and other contact details; and (d) include a statement to the effect that: (i) the person is a Category A patient; and (ii) the person, or the person’s guardian, has given informed consent to the use of the device in or on the person. (1C) A person commits an offence of strict liability if the person: (a) completes a statement referred to in subparagraph (1)(b)(ii); and (b) does not send a copy of the statement to the Secretary within 28 days after the use of the exempt device to which the statement relates. Penalty: 10 penalty units. (2) In this regulation: > Category A patient means a person who is seriously ill with a condition that is reasonably likely to lead to the person’s death within less than a year or, without early treatment, to the person’s premature death. > informed consent, in relation to treatment or proposed treatment of a person, means consent to the treatment of the person that is freely given on the basis of information concerning the potential risks and benefits of the treatment that is sufficient to allow the person, or the person’s guardian, to make an informed decision about whether to consent to the treatment. ### Division 7.2—Exemptions for experimental uses #### 7.3 Conditions of approval—use of device by person to whom approval is given (Act s 41HB) (1) For subsection 41HB(3) of the Act, the conditions mentioned in this regulation apply to an approval granted to a person to use a kind of medical device solely for experimental purposes in humans. (2) Before the commencement of any clinical trial proposed to be undertaken in relation to the device, the person to whom the approval is granted and the principal investigator of the clinical trial must give to the Secretary: (a) a written assurance that each clinical trial will be conducted in accordance with the ‘National Statement on Ethical Conduct in Research Involving Humans’, published by the National Health and Medical Research Council, as in force from time to time; and (b) a written undertaking: (i) that the person will comply with any request by an authorised person, whether made before or after the commencement of a clinical trial, to give to the authorised person information about the conduct of the trial; and (ii) that the person will allow an authorised person to do any of the things mentioned in regulation 7.4 in relation to a clinical trial. #### 7.4 Powers of authorised persons in relation to medical devices being used in clinical trials (1) Subject to subregulation (2), an authorised person may do any of the following things in relation to a clinical trial mentioned in regulation 7.3 or in item 2.3 of the table in Part 2 of Schedule 4: (a) enter a site of the trial; (b) search the site and any thing on the site; (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; (d) take photographs, make video recordings or make sketches of the site or any thing on the site; (f) request the principal investigator of the trial to: (i) answer any question asked by the authorised person; or (ii) produce any book, record or other document requested by the authorised person. > Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document. (2) An authorised person is not entitled to do a thing mentioned in subregulation (1) if: (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised person to produce his or her identity card for inspection; and (b) the authorised person fails to comply with the request. > Note: See section 52 of the Act in relation to identity cards. (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not obstruct the search. (4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time. #### 7.5 Conditions of approval—use of device by another person (Act s 41HB) (1) For subsection 41HB(7) of the Act, the conditions mentioned in this regulation apply to the use by a person, for experimental purposes in humans, of a kind of medical device that is the subject of an approval granted to someone else under paragraph 41HB(1)(e) of the Act. (2) The use of the device must comply with a procedural protocol approved by the ethics committee that is to be responsible for monitoring the conduct of the trial at each trial site (the responsible ethics committee). (3) The use of the device must be in accordance with the ethical standards set out in the ‘National Statement on Ethical Conduct in Research Involving Humans’, published by the National Health and Medical Research Council, as in force from time to time. (4) The person must cease using the device if the responsible ethics committee informs the principal investigator of the clinical trial that the use is inconsistent with: (a) the protocol mentioned in subregulation (2); or (b) any condition subject to which approval for the use was given. ### Division 7.3—Exemptions for medical practitioners #### 7.6 Classes of medical practitioners and recipients (Act s 41HC) (1) A class of medical practitioners prescribed for the purposes of paragraph 41HC(4)(a) of the Act is the class of medical practitioners each of whom is: (a) a specialist medical practitioner who is engaged in clinical practice in a hospital and is endorsed by the ethics committee of the hospital; or (b) a specialist medical practitioner who is engaged in treating patients outside a hospital and is endorsed by an ethics committee that: (i) has expertise relating to the principal activities of the practitioner; or (ii) conducts its activities within the geographic area where the medical practitioner is engaged in treating patients. (2) A class of recipients prescribed for the purposes of paragraph 41HC(4)(c) of the Act is the class of recipients each of whom is a person who is suffering from a life‑threatening or otherwise serious illness or condition. (3) For subsection 41HC(4) of the Act, each of the following is an exceptional circumstance in which paragraph 41HC(4)(b) of the Act does not apply: (a) the Secretary is satisfied that the medical practitioner has no access to an ethics committee; (b) the medical practitioner has an endorsement from a specialist college that does not have an ethics committee, but has expertise relevant to the treatment of the condition for which the authority is sought. #### 7.7 Circumstances for supply of device under authority (Act s 41HC) For subsection 41HC(5) of the Act, a kind of medical device may be supplied under an authority under subsection 41HC(1) of the Act if the supplier of the device complies with the directions relating to the therapeutic intervention, or class of therapeutic intervention, mentioned in the authority. #### 7.8 Information to be notified in relation to supply of certain medical devices For the purposes of paragraph 41HC(6C)(b) of the Act, the information that must be contained in a notification under subsection 41HC(6B) of the Act in relation to the supply by a health practitioner of a medical device to a person is as follows: (a) the person’s initials, date of birth and gender; (b) each medical condition in relation to which the device was supplied; (c) each intended use of the device in relation to which the device was supplied; (d) the product name of the device; (e) the name of the manufacturer of the device; (f) a brief description of the device including whether the device is a variant; (g) the practitioner’s name, AHPRA number and contact details; (h) the health profession in which the practitioner is registered or licensed to practise; (i) the address of the practitioner’s principal place of practice. ## Part 8—Obtaining information #### 8.1A Matters for which information and documents can be requested For paragraph 41JA(1)(j) of the Act, the following matters are prescribed: (a) whether the devices are medical devices; (b) whether the devices are intended for a specified purpose, as ascertained under subsection 41BD(2) of the Act; (c) whether the devices are correctly classified under Division 3.1 of Part 3; (d) whether procedures are in place, including a written agreement with the manufacturer of the devices, that require the manufacturer to make available information mentioned in paragraph 41FD(e) or (g) of the Act; (e) whether the devices contain substances that are prohibited imports under the Customs Act 1901; (f) whether the devices are to be used exclusively for one or more of the purposes specified under section 41BEA of the Act; (g) the accuracy and completeness of information included in or with the application; (h) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of the Therapeutic Goods Regulations 1990 for exempting a person from liability to pay an annual charge for inclusion of the devices in the Register for a financial year, based on low value turnover of the devices; (i) matters relating to an application to the Secretary under regulation 43AAH of the Therapeutic Goods Regulations 1990 to waive the annual charge for inclusion of the devices in the Register for a financial year; (j) matters relating to: (i) any malfunction or deterioration in the characteristics or performance of the devices; or (ii) any inadequacy in the design, manufacture, labelling, instructions for use or advertising materials of the devices; or (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the devices; that has led to any complaint or problem in relation to the devices, no matter how minor; (k) matters of the kind mentioned in subsection 41MP(2) of the Act; (l) whether the devices comply with conditions to which the inclusion of the devices in the Register is subject; (m) matters relating to the formulation of ingredients that constitute the devices. #### 8.1 Notice period (Act s 41JA) For paragraph 41JA(2)(a) of the Act, the notice period for a kind of medical device in relation to which a person is required, by written notice given by the Secretary under subsection 41JA(1) of the Act, to give information to the Secretary is: (a) if the information relates to manufacturing records—5 years; and (b) if the information relates to distribution records: (i) in the case of records relating to a Class III medical device, or Class IIb medical device that is an implantable medical device—10 years; and (ii) in the case of records relating to any other device—5 years. ## Part 8AA—Mandatory reporting of adverse events by healthcare facilities #### 8AA.1 Healthcare facilities For the purposes of paragraph (c) of the definition of healthcare facility in subsection 3(1) of the Act, a day‑hospital facility is prescribed. #### 8AA.2 Reportable medical devices For the purposes of the definition of reportable medical device in subsection 3(1) of the Act, the following kinds of medical devices are prescribed: (a) a Class III medical device; (b) a Class 4 IVD medical device. #### 8AA.3 Report requirements Content of report (1) For the purposes of paragraph 41JM(5)(c) of the Act, the following information is prescribed: (a) any healthcare identifier assigned to the healthcare facility under the Healthcare Identifiers Act 2010; (b) if subsection 41JM(2) of the Act applies: (i) the day of the use of the reportable medical device as mentioned in paragraph 41JM(2)(a) of the Act; and (ii) the day of the death of the person as mentioned in paragraph 41JM(2)(b) of the Act or the day the serious deterioration in the health of the person as mentioned in paragraph 41JM(2)(b) of the Act is first identified; and (iii) in the case of a serious deterioration in the health of the person—the nature, or a description, of that serious deterioration; (c) if subsection 41JM(3) of the Act applies—the day of the intervention as mentioned in paragraph 41JM(3)(a) of the Act; (d) if subsection 41JM(4) of the Act applies: (i) the day of the provision of the treatment as mentioned in paragraph 41JM(4)(a) of the Act; and (ii) the nature, or a description, of the serious deterioration in the health of the person; (e) the name of the manufacturer of the reportable medical device, if known to the chief executive officer of the healthcare facility. Timing of report (2) For the purposes of paragraph 41JM(6)(a) of the Act, the period prescribed is the following: (a) if subsection 41JM(2) of the Act applies—the period of 10 days beginning on the day of the death of the person as mentioned in paragraph 41JM(2)(b) of the Act or the day the serious deterioration in the health of the person as mentioned in paragraph 41JM(2)(b) of the Act is first identified; (b) if subsection 41JM(3) of the Act applies—the period of 45 days beginning on the day of the intervention as mentioned in paragraph 41JM(3)(a) of the Act; (c) if subsection 41JM(4) of the Act applies—the period of 45 days beginning on the day of the provision of the treatment as mentioned in paragraph 41JM(4)(a) of the Act. Manner of giving report (3) For the purposes of paragraph 41JM(6)(b) of the Act, the manner prescribed is an electronic form (other than fax or a scanned document). ## Part 8A—Waiver and refund of charges #### 8A.1 Definitions In this Part: > charge year has the same meaning as in the Therapeutic Goods (Charges) Regulations 2018. > transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if: (a) the medical device was, immediately before 25 November 2021, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or (b) on 25 November 2021: (i) the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and (ii) the application had not been finally determined. ```html <table cellspacing="0" cellpadding="0" style="width:411.1pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:400.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Transitional medical device</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"></td><td style="width:180.7pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 1</td><td style="width:152.3pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 2</td></tr><tr><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Item</td><td style="width:180.7pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Kind of medical device</td><td style="width:152.3pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class of medical device or application</td></tr></thead><tbody><tr><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1</td><td style="width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in subclause 3.4(4B) of Schedule 2</td><td style="width:152.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class IIb</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">2</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in clause 5.10 of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class I or Class IIa</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">3</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in clause 5.11 of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class I, Class IIa or Class IIb</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">4</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in subclause 4.2(4) of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class IIa or Class IIb</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">5</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in subclause 3.2(3A) of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class IIa or Class IIb</td></tr></tbody></table> ``` #### 8A.2 Waiver of charges in relation to transitional medical devices (1) This subregulation applies in relation to a kind of medical device if, at any time during a charge year: (a) the medical device is a transitional medical device; and (b) the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and (c) the medical device is included in the Register and classified both as: (i) a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and (ii) a class of medical device described in the provision mentioned in column 1 of that item; and (d) the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time. (2) The Secretary must, on behalf of the Commonwealth, waive the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of transitional medical device in the Register during the charge year if: (a) the person liable to pay the charge applies for the charge to be waived for the charge year; and (b) the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and (c) the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device. #### 8A.3 Refund of certain charges in relation to transitional medical devices (1) This subregulation applies in relation to a kind of medical device if, at any time during a charge year: (a) the medical device is a transitional medical device; and (b) the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and (c) the medical device is included in the Register and classified both as: (i) a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and (ii) a class of medical device described in the provision mentioned in column 1 of that item; and (d) the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time; and (e) the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of medical device in the Register during the charge year has been paid. (2) The Secretary must, on behalf of the Commonwealth, refund an amount equal to the charge paid if: (a) the person who paid the charge applies for the charge to be refunded; and (b) the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and (c) the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device. ## Part 9—Fees ### Division 9.1—Fees #### 9.1 Fees The following fees are prescribed: (a) the fee mentioned in column 4 of an item in Part 1 of Schedule 5 in relation to the matter mentioned in column 2 of that item; (b) the additional fees mentioned in Part 2 of Schedule 5. ### Division 9.1A—Reduced fee for consent to import, supply or export implantable medical devices—information requirements #### 9.1AA Working out the reduced fee (1) If: (a) an application is covered by paragraph (a) of item 1.15 of the table in Part 1 of Schedule 5; and (b) the application is made solely in relation to: (i) the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1 to the medical device; or (ii) the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical device, and the reason for the medical device not complying with one or more of those clauses is that the medical device is affected by the EU transition (within the meaning of subregulation (3)); or (iii) both subparagraphs (i) and (ii); the amount of the fee is not worked out in accordance with Part 1 of Schedule 5\. Instead, the amount of the fee is $32. (2) If: (a) an application is covered by paragraph (b) of item 1.15 of the table in Part 1 of Schedule 5; and (b) the application is made solely in relation to: (i) the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1 to the medical devices; or (ii) the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical devices, and the reason for the medical devices not complying with one or more of those clauses is that the medical devices are affected by the EU transition (within the meaning of subregulation (3)); or (iii) both subparagraphs (i) and (ii); the amount of the fee is not worked out in accordance with Part 1 of Schedule 5\. Instead, the amount of the fee is worked out in accordance with the following method statement: Method statement Step 1. Work out the number of separate entries in the Register in relation to the devices concerned. Step 2. The amount of the fee is the number at step 1 multiplied by $32. (3) For the purposes of this regulation, a medical device is affected by the EU transition if: (a) the medical device is of a kind included in the Register; and (b) the basis of certifying the matter referred to in paragraph 41FD(f) of the Act for devices of that kind was an overseas regulator conformity assessment document issued under one of the following (as in force from time to time): (i) Council Directive 90/385/EEC of the Council of the European Communities; (ii) Council Directive 93/42/EEC of the Council of the European Communities; (iii) Directive 98/79/EC of the European Parliament and the Council of the European Union; (iv) ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, published by the International Organization for Standardization; and (c) a new overseas regulator conformity assessment document has been issued, or is expected to be issued, in respect of devices of that kind under one of the following: (i) Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the European Union; (ii) Regulation 2017/746 (as in force from time to time) of the European Parliament and the Council of the European Union; (iii) the Medical Device Single Audit Program (within the meaning of the Therapeutic Goods (Overseas Regulators) Determination 2018). ### Division 9.2—Conformity assessment body determination assessment fees #### 9.1A Purposes of this Division This Division is made for the purposes of paragraph 41EWA(3)(g) of the Act. #### 9.1B Conformity assessment body determination assessment fees (1) A fee is payable in relation to the assessment of an application for a conformity assessment body determination mentioned in column 2 of item 1.4D, 1.4E or 1.4F in Part 1 of Schedule 5. (2) Subject to regulation 9.1C, the amount of the fee is the amount mentioned in column 4 of that item. (3) The fee is payable by the applicant. (4) Subject to regulation 9.1D, the fee is due and payable in full on the day specified under subregulation (5) of this regulation. (5) For the purposes of subregulation (4), the Secretary may give the applicant a written notice specifying when the fee is due and payable in full. #### 9.1C Conformity assessment body determination assessment fees—abridged assessment If the Secretary considers that he or she has sufficient information to allow assessment of an application for a conformity assessment body determination to be abridged: (a) the Secretary may decide to conduct an abridged assessment of the application; and (b) if the Secretary so decides—the Secretary may reduce the amount of the conformity assessment body determination assessment fee for assessment of the application. #### 9.1D Payment of conformity assessment body determination assessment fees by instalments (1) The Secretary may approve, in relation to an application (the relevant application) for a conformity assessment body determination, the payment of a conformity assessment body determination assessment fee by instalments if: (a) the applicant for the determination has applied in writing to pay the amount by instalments; and (b) the amount payable exceeds $10,000; and (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if the amount is paid before the commencement of the assessment of the relevant application; and (d) any information or material required under subregulation (3) has been given to the Secretary. (2) An application under subregulation (1) must: (a) state the reasons why paying the full amount of the fee before the assessment of the relevant application commences would cause financial hardship to the applicant; and (b) have with it documents or other material in support of the application. (3) The Secretary may reasonably require information or material in addition to the documents or material mentioned in paragraph (2)(b). (4) If the Secretary approves an application for payment by instalments: (a) half of the fee is due for payment before the commencement of the assessment of the relevant application; and (b) one‑quarter of the fee is due for payment at the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and (c) the remaining one‑quarter of the fee is due for payment: (i) if the relevant application is withdrawn—when the relevant application is withdrawn; and (ii) in any other case—when the applicant is notified of the Secretary’s decision in respect of the relevant application under regulation 4A.7 or 4A.9. (5) If the Secretary receives an application for payment by instalments, the Secretary must: (a) within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and (b) if the application is approved—include with the notice information about the amount of each instalment and when it is due for payment. (6) If: (a) the Secretary approves an application for payment by instalments; and (b) any amount of the instalment payable by the applicant is not paid when it becomes due for payment; the balance of the fee becomes due for payment. #### 9.1E Recovery of conformity assessment body determination assessment fees A conformity assessment body determination assessment fee may be recovered by the Commonwealth as a debt due to the Commonwealth. #### 9.1F Refund of conformity assessment body determination assessment fees if applications withdrawn (1) The applicant for a conformity assessment body determination may apply to the Secretary, in writing, for a refund of the conformity assessment body determination assessment fee for the application if the applicant withdraws the application: (a) after all or part of the fee becomes due and payable; and (b) before the Secretary makes a decision on the application under subregulation 4A.6(1). (2) Within 20 working days after receiving the application, the Secretary must: (a) decide whether to refund any of the fee; and (b) if so—the amount of the fee to be refunded. (3) To avoid doubt, the applicant is not entitled to a refund of the application fee for the application. ### Division 9.3—Assessment fees and reductions or refunds of fees connected with applications for conformity assessment certificates #### 9.2 Application audit assessment fee (Act ss 41LA, 41LB) For section 41LB of the Act, an application audit assessment fee is due and payable 28 days after the day that the applicant is notified of the amount of the fee. #### 9.3 Conformity assessment fee (Act ss 41LA, 41LB) (1) For section 41LB of the Act, and subject to subregulation (2), a conformity assessment fee for consideration of an application for a conformity assessment certificate is due and payable in full: (a) on the day specified in a notice given to the applicant by the Secretary; or (b) if the application is withdrawn before a decision is made in relation to the application and within the period mentioned in subregulation 4.3(2)—on the day when the application is withdrawn. > Note: See section 41LE of the Act in relation to the requirement to pay three‑quarters only of the conformity assessment fee in relation to certain kinds of applications. (2) If: (a) in accordance with section 41LE of the Act, an applicant has paid three‑quarters of the conformity assessment fee in relation to an application for a conformity assessment certificate; and (b) the application is withdrawn before a decision is made in relation to the application and within the period mentioned in subregulation 4.3(2); the part of the fee that is unpaid is due and payable on the day when the application is withdrawn. (3) If the Secretary considers that additional assessment work is required in relation to an application for a conformity assessment certificate, the additional amount is due and payable on the day specified in a notice given to the applicant by the Secretary. > Note: The fee for any additional work is prescribed in item 1.12 of Schedule 5. #### 9.5 Payment of assessment fee by instalments (Act s 41LC) (1) For section 41LC of the Act, the Secretary may, subject to subregulation (7), approve, in relation to a kind of medical device, the payment of an assessment fee by instalments if: (a) the person who is liable to pay the fee (the applicant) has applied in writing to pay the amount by instalments; and (b) the amount payable exceeds $10 000; and (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if the amount is paid before the commencement of the consideration or audit of the application to which the fee relates (the relevant application); and (d) any information or material required under subregulation (3) has been given to the Secretary. (2) An application under subregulation (1) must: (a) state the reasons why paying the full amount of the fee before the consideration or audit of the relevant application commences would cause financial hardship to the applicant; and (b) have with it documents or other material in support of the application. (3) The Secretary may reasonably require information or material in addition to the documents or material mentioned in paragraph (2)(b). (4) If the Secretary approves an application for payment by instalments: (a) half of the fee is due for payment before the commencement of the consideration or audit of the relevant application; and (b) one‑quarter of the fee is due for payment at the end of one month after the last day when the amount referred to in paragraph (a) may be paid; and (c) the remaining one‑quarter of the fee is due for payment: (i) if the relevant application is withdrawn—when the application is withdrawn; and (ii) in any other case—when the applicant is notified of the Secretary’s decision in respect of the relevant application under section 41EE or 41FJ of the Act. (5) If the Secretary receives an application for payment by instalments, the Secretary must: (a) within 30 days of receiving the application and any information or material required under subregulation (3), give notice, in writing, to the applicant stating whether the application has been approved; and (b) if the application is approved, include with the notice information about the amount of each instalment and when it is due for payment. (6) If: (a) the Secretary approves an application for payment by instalments; and (b) any amount of the instalment payable by the applicant is not paid when it becomes due for payment; the balance of the fee becomes due for payment. (7) This regulation does not apply if another assessment fee, or an evaluation fee under section 24 of the Act, (or part of either of those kinds of fee) that is due for payment by the applicant is unpaid. #### 9.6 Reduction of assessment fees The Secretary may reduce by 70% the amount of an assessment fee specified in Schedule 5 in relation to a medical device if the supply of the medical device: (a) is in the interest of public health; and (b) would not be commercially viable for the manufacturer or sponsor of the medical device if the full amount of the fee were paid. #### 9.7 Reduction of assessment fees—abridged assessment (1) This regulation applies to an assessment fee specified in Part 1 of Schedule 5 in relation to any of the following: (a) items 1.2, 1.3 and 1.3A (review of conformity assessment certificate); (b) items 1.9 and 1.9A (initial assessment under conformity assessment procedures); (c) item 1.10 (assessment consequent on a change to: (i) a medical device; or (ii) the quality management system applying to a medical device); (ca) item 1.10A (assessment because of changes or proposed changes to: (i) an IVD medical device; or (ii) the quality management system applying to an IVD medical device); (d) items 1.13, 1.14, 1.14A, 1.14AA, 1.14B and 1.14C (application subject to audit assessment); (e) item 1.16 (intermediate stage assessment or verification procedures). (2) The Secretary may reduce the amount of the assessment fee if the Secretary has information that allows the assessment to be abridged, being information about: (a) the medical device to which the fee relates; or (b) some or all aspects of whether the conformity assessment procedures have been applied to the medical device. #### 9.8 Refund of fees—kinds of medical devices covered by former regulation 4.1 (1) If: (a) on or after 1 January 2019 and before the commencement of this regulation, a person made an application under section 41EB of the Act for a conformity assessment certificate in respect of a kind of medical device covered by regulation 4.1 (as in force immediately before 28 July 2021); and (b) on or after 1 January 2019 and before 1 December 2021, the person paid all or part of one or more of the following: (i) the fee covered by item 1.1 of the table in Part 1 of Schedule 5 in connection with the application; (ii) the fee covered by item 1.9, 1.9A, 1.10 or 1.10A of the table in Part 1 of Schedule 5 (to the extent that fee is in connection with the application); (iii) the fee covered by item 1.11 or 1.12 of the table in Part 1 of Schedule 5 (to the extent that fee is in connection with the application); (iv) the fee covered by clause 2.1 or 2.2 in Part 2 of Schedule 5 (to the extent that fee is in connection with the application); and (c) on or after 28 July 2021 and before 1 March 2022, the person, by notice in writing given to the Secretary, withdrew the application; and (d) the person withdrew the application before the Secretary had made a decision on the application; and (e) on or after 28 July 2021 and before 1 March 2022, the person requested the Secretary, in writing, for a refund of that fee; and (f) the request is accompanied by information that satisfies the requirements of subparagraphs 41FDB(2)(d)(i) and (ii) of the Act for that classification of medical device; then, before the end of the applicable period, the Secretary must: (g) decide whether or not to refund any of that fee; and (h) if the Secretary decides to make a refund on behalf of the Commonwealth—decide the amount of that fee to be refunded. (2) In making a decision under paragraph (1)(g) or (h), the Secretary must take into account the extent of completion of the assessment or assessments, or of the testing, in connection with the application for the conformity assessment certificate, at the time the person withdrew the application. (3) Subregulation (2) does not limit the matters the Secretary may take into account. (4) For the purposes of this regulation, the applicable period is: (a) if the person requested the refund on or after 28 July 2021 and before the commencement of this regulation—the period of 20 working days beginning on the day this regulation commences; or (b) if the person requested the refund on or after the commencement of this regulation—the period of 20 working days beginning on the day the Secretary received the request. ### Division 9.4—Other refunds or waivers of fees #### 9.9 Other refunds or waivers of fees Refunds (1) For the purposes of paragraph 63(3)(b) of the Act, the Secretary must, on behalf of the Commonwealth, refund the fee covered by item 1.6A of the table in Part 1 of Schedule 5 if: (a) the request referred to in that item was made on or after 21 August 2021 and before the commencement of this regulation; and (b) that request was for revocation of the cancellation of an entry of a kind of medical device covered by item 3A, 3B, 3C, 3D or 3E of the table in Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020, as that instrument was in force before that commencement. Waivers (2) For the purposes of paragraph 63(3)(b) of the Act, the Secretary must, on behalf of the Commonwealth, waive the fee covered by item 1.6A of the table in Part 1 of Schedule 5 if: (a) the request referred to in that item is made on or after the commencement of this regulation and before the end of 31 December 2022; and (b) that request is for revocation of the cancellation of an entry of a kind of medical device covered by item 3A, 3B, 3C, 3D or 3E of the table in Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020, as that instrument is in force from time to time. (3) For the purposes of paragraph 63(3)(b) of the Act, the Secretary must, on behalf of the Commonwealth, waive the fee covered by item 1.5 of the table in Part 1 of Schedule 5 if: (a) the application referred to in that item is made on or after the commencement of this regulation and before the end of 31 December 2022; and (b) that application is for inclusion in the Register of a kind of medical device covered by item 3A, 3B, 3C, 3D or 3E of the table in Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020, as that instrument is in force from time to time; and (c) the person making that application had made a request before the commencement of this regulation under paragraph 41GL(d) of the Act for cancellation of the entry of the kind of device that is the subject of that application. ## Part 9A—Australian Unique Device Identification Database #### 9A.1 Australian Unique Device Identification Database (1) For the purposes of section 41CE of the Act, the following provisions of this regulation have effect. Establishing the database (2) The Secretary must cause a database to be established (the Australian Unique Device Identification Database). Maintaining the database (3) The Secretary must: (a) maintain the whole of the database; or (b) on behalf of the Commonwealth, enter into a written agreement with a person to maintain the whole of the database; or (c) maintain some of the content of the database and, on behalf of the Commonwealth, enter into a written agreement with a person to maintain the remaining content of the database. Personal information (4) The database must not include personal information, unless the personal information: (a) is the name of a person in relation to whom a kind of medical device is included in the Register; or (b) is about an authorised representative of the manufacturer of a kind of medical device; or (c) is about an authorised representative of a person in relation to whom a kind of medical device is included in the Register. (5) Personal information covered by paragraph (4)(b) or (c) must not be included in the database unless the authorised representative concerned consents, in writing, to that inclusion. Retention of information during suspension or cancellation of Register entry (6) If information is included in the database in relation to UDI medical devices that are a type of model and that model is covered by a suspension under Part 4‑6 of the Act, that information must not be removed from the database during the period of the suspension unless the Secretary is satisfied that it is appropriate in all the circumstances to do so. (7) If information is included in the database in relation to UDI medical devices that are a type of model and that model is covered by a cancellation under Part 4‑6 of the Act, that information must not be removed from the database unless the Secretary is satisfied that it is appropriate in all the circumstances to do so. Removal of information (8) The Secretary may remove information from the database in relation to UDI medical devices that are a type of model if: (a) the information is not information required by this instrument to be included in the database; and (b) a sponsor or manufacturer of those medical devices requests the Secretary, in writing, to remove the information. (9) The Secretary may remove information from the database in relation to UDI medical devices that are a type of model if the Secretary is satisfied that the information is incomplete or incorrect. (10) The Secretary must remove information from the database that is personal information, other than personal information covered by paragraph (4)(a), (b) or (c). (11) However, the Secretary must remove personal information covered by paragraph (4)(b) or (c) from the database if the authorised representative concerned requests the Secretary, in writing, to do so. Corrections to information (12) The Secretary may correct information in the database in relation to UDI medical devices that are a type of model if the Secretary is satisfied that: (a) it is not possible or practicable for a sponsor or manufacturer, or another person on behalf of a sponsor or manufacturer, of those medical devices to make the correction; or (b) it is in the interests of public health or safety to do so. Making database publicly available (13) The Secretary may arrange for the whole or a part of the database to be made publicly available. However, personal information covered by paragraph 41CE(2)(b) or (c) of the Act must not be made publicly available. ## Part 10—Miscellaneous #### 10.1 Authorised persons The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations: (a) an officer of the Department, of another Department or of an authority of the Commonwealth; (b) an officer of: (i) a Department of State of a State; or (ii) a Department or administrative unit of the Public Service of a Territory; or (iii) an authority of a State or of a Territory; being a Department, unit or authority that has functions relating to health matters. #### 10.2 Information about sponsor (1) The sponsor of a medical device must ensure that the sponsor’s name and address are: (a) provided with the device in such a way that a user of the device can readily identify the sponsor; and (b) located in accordance with clause 13.2 in Schedule 1. Penalty: 10 penalty units. (2) If the sponsor of a medical device arranges for a label to be attached or affixed to the device for the purpose of complying with subregulation (1) or for any other purpose (for example, to comply with a labelling requirement under the law of a State or Territory), the label must not in any way adulterate the device or obscure the information provided with the device by the manufacturer. Penalty: 10 penalty units. #### 10.3 Custom‑made medical devices—information about manufacturer (1) The manufacturer of a custom‑made medical device that is manufactured in Australia must, within 2 months after the medical device is first manufactured in Australia, give the following information about the device to the Secretary: (a) the manufacturer’s name and business address; (b) a description of the kinds of medical devices being custom‑made by the manufacturer (including the device nomenclature system code for any such devices). Penalty: 10 penalty units. (2) The sponsor of a custom‑made medical device that is imported into Australia must, within 2 months after the medical device is first imported into Australia, give the following information about the device to the Secretary: (a) the sponsor’s name and address; (b) the manufacturer’s name and business address; (c) a description of the kinds of medical devices being custom‑made by the manufacturer (including the device nomenclature system code for any such devices). Penalty: 10 penalty units. #### 10.3A Custom‑made medical devices—information about supplies (1) A person commits an offence if: (a) the person is the manufacturer of a custom‑made medical device that is manufactured in Australia in a financial year (the relevant financial year); and (b) the person does not, before 1 October in the next financial year, give the Secretary a written report that relates to all the custom‑made medical devices the person manufactured in the relevant financial year and that complies with subregulation (3). Penalty: 10 penalty units. (2) A person commits an offence if: (a) the person is the sponsor of a custom‑made medical device that the person imported into Australia in a financial year (the relevant financial year); and (b) the person does not, before 1 October in the next financial year, give the Secretary a written report that relates to all the custom‑made medical devices the person imported in the relevant financial year and that complies with subregulation (3). Penalty: 10 penalty units. (3) A report under this regulation must: (a) be made in accordance with a form approved, in writing, by the Secretary; and (b) contain the information that the form requires. (4) Without limiting subregulation (3), the form may require details in relation to supplies of custom‑made medical devices covered by paragraph (1)(b) or (2)(b). (5) The Secretary must make the form available on the Therapeutic Goods Administration’s website. #### 10.4 Offences—period for notifying adverse events (Act s 41MP) For paragraph 41MP(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MP(2) of the Act is the relevant period specified in regulation 5.7. #### 10.4AA Civil penalty—period for notifying adverse events For the purposes of paragraph 41MPA(1)(c) of the Act, the period for giving information of a kind mentioned in subsection 41MPA(2) of the Act is the relevant period specified in regulation 5.7. #### 10.4A Secretary may maintain a system to enhance safe and effective use of particular medical devices (1) The Secretary may, for the purpose of performing his or her functions, or exercising his or her powers, in relation to therapeutic goods (including under the Act or under another law), maintain either or both of the following: (a) a system that is designed to enhance the safe and effective use of implantable breast medical devices (an implantable breast medical devices registry); (b) a system that is designed to enhance the safe and effective use of implantable cardiac medical devices (an implantable cardiac medical devices registry). (2) An implantable breast medical devices registry, or an implantable cardiac medical devices registry, may involve any of the following: (a) collecting and analysing data and information in relation to the relevant medical devices; (b) monitoring the safety and performance of the relevant medical devices; (c) identifying particular medical devices (if any) in relation to which there are safety or performance risks or concerns; (d) providing information about the safety and performance of the relevant medical devices to: (i) authorities or bodies of the Commonwealth, a State or a Territory that have functions relating to therapeutic goods or health; or (ii) health professionals; or (iii) persons or bodies involved in the manufacture, importation or supply of the relevant medical devices in Australia; or (iv) patients; or (v) the general public. (3) For paragraph (2)(a), the following are examples of data and information that may be collected and analysed in relation to the relevant medical devices: (a) data and information relating to the safety and performance of the relevant medical devices; (b) data and information about any revision procedures relating to the relevant medical devices and the reasons for those procedures; (c) in relation to each particular medical device that has been implanted in a patient: (i) information identifying the medical device, including the brand and batch or serial number; and (ii) the date on which the medical device was implanted; and (iii) the name of the hospital or surgery where the medical device was implanted; and (iv) data or information that tracks the performance of the medical device and the patient outcomes following implant of the medical device. (4) The Secretary may enter into a written agreement with a person or body for the purpose of maintaining an implantable breast medical devices registry or an implantable cardiac medical devices registry. (5) An implantable breast medical devices registry or an implantable cardiac medical devices registry: (a) may be maintained at a place and in a form that is acceptable to the Secretary; and (b) may involve keeping records, or carrying out other actions, by electronic means. #### 10.5 Delegation—powers and functions under these Regulations The Secretary may, by signed instrument, delegate a power or function of the Secretary under these Regulations to an officer of the Department. #### 10.6 Delegation—powers under paragraph 41HB(1)(d) of the Act (1) In this regulation: > delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary, under paragraph 41HB(1)(d) of the Act, to approve the use of a specified medical device or kind of medical device in the treatment of a person. (2) A delegate may only be a person who: (a) is a medical practitioner employed by an institution that has an ethics committee; and (b) is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act. (3) If: (a) a person proposes another person under paragraph (2)(b) as a person to be a delegate; and (b) that other person becomes a delegate; the first‑mentioned person must supervise each approval that the delegate grants under the delegation. (4) An instrument of delegation must describe the person or class of persons to be treated with the medical device or kind of medical device to which the delegation relates. (5) A delegation may be made for the purpose of allowing the delegate to grant an approval in relation to: (a) a particular medical device or kind of medical device; or (b) a particular class of medical devices; for treating a specific illness or condition. (6) A delegate may grant an approval under a delegation only if: (a) a medical practitioner, other than the delegate, has stated in writing that the person who is to be treated with the medical device of a kind to which the approval relates has an illness or condition that requires treatment with that kind of medical device; and (b) an ethics committee has agreed to the granting of an approval under paragraph 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the kind of medical device to which the delegation relates. #### 10.6A Delegation of Secretary’s powers under section 41HD of the Act The following positions are prescribed for the purposes of subsection 57(9) of the Act: (a) an SES Band 1, 2 or 3 position; (b) each position classified as a Medical Officer Class 3, 4, 5 or 6; (c) an Executive Level 1 or 2 position. #### 10.6B Forms or manners—software requirements If a provision of these Regulations provides for the approval or specification of a form or manner of giving an application, notice or other document, the approval or specification may require or permit the application, notice or other document to be given in accordance with specified software requirements: (a) on a specified kind of data processing device; or (b) by way of a specified kind of electronic transmission. #### 10.7 Review of decisions (1) In this regulation: > decision has the same meaning as in the Administrative Review Tribunal Act 2024. > initial decision means a decision of the Secretary under any of the following provisions: (a) subparagraph 4.3C(1)(b)(ii); (aa) subregulation 4.3E(1); (ab) subregulation 4.10(2); (aba) the following provisions (about conformity assessment body determinations): (i) subregulation 4A.6(1); (ii) subparagraph 4A.7(3)(a)(i) or (ii); (iii) subregulation 4A.7(5); (iv) regulation 4A.20; (v) subregulation 4A.22(3); (vi) subregulation 4A.23(1); (vii) subregulation 4A.26(1); (viii) subregulation 4A.27(1); (ix) subregulation 4A.28(1); (x) subregulation 4A.29(1); (ac) subparagraph 5.4B(1)(b)(ii); (ad) subregulation 5.4D(1); (ae) the following provisions (about conformity assessment body determination assessment fees): (i) regulation 9.1C; (ii) subregulation 9.1D(1); (iii) subregulation 9.1F(2); (c) subregulation 9.5(1); (d) paragraph 9.8(1)(g) or (h); (e) subregulation 9A.1(9). > Note: See also subregulation (1A) of this regulation. > reviewable decision means a decision of the Minister under subregulation (4). (1A) Each of the following decisions of the Secretary is an initial decision: (aa) a decision to refuse to agree to an application under subregulation 8A.2(2) or 8A.3(2) for a waiver or refund of annual charge; (a) a decision to refuse to agree to a notification covered by paragraph (a) of the column headed “Conditions” in item 2.3 of the table in Part 2 of Schedule 4 being given before the end of a period nominated by the sponsor concerned; (b) a decision to refuse to agree to a notification covered by paragraph (h) of the column headed “Conditions” in item 2.3 of the table in Part 2 of Schedule 4 being given before the end of a period nominated by the sponsor concerned; (c) a decision to make a medical device the subject of a determination as referred to in paragraph (d) of the column headed “Kinds of medical devices” in item 2.17 of the table in Part 2 of Schedule 4. (2) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department. (3) A person whose interests are affected by an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice. (3A) Despite subregulation (3), only the following persons may make a request under that subregulation in relation to a conformity assessment (priority applicant) determination: (a) if the initial decision was to refuse to make the determination—the person who applied for the determination; (b) if the initial decision was to revoke the determination—the priority applicant specified in the determination. (3B) Despite subregulation (3), only the following persons may make a request under that subregulation in relation to a medical devices (priority applicant) determination: (a) if the initial decision was to refuse to make the determination—the person who applied for the determination; (b) if the initial decision was to revoke the determination—the priority applicant specified in the determination. (4) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (3), and may: (a) confirm the initial decision; or (b) revoke the initial decision; or (c) revoke the initial decision and make a decision in substitution for the initial decision. (5) After reconsidering an initial decision, the Minister must give to the applicant a notice in writing stating: (a) the result of the reconsideration; and (b) that the applicant may, unless subsection 269(7) of the Administrative Review Tribunal Act 2024 applies: (i) apply for a statement setting out the reasons for the decision on reconsideration; and (ii) subject to that Act, make an application to the Administrative Review Tribunal for review of that decision. (6) If a person who makes a request under subregulation (3) does not receive notice of the decision of the Minister on reconsideration within 60 days after making the request, the Minister is taken to have confirmed the initial decision. (7) If written notice of the making of an initial decision is given to a person whose interests are affected by the decision, the notice must include a statement to the effect that a person whose interests are affected by the decision may: (a) seek a reconsideration of the decision under this regulation; and (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision. (8) Any failure to comply with the requirements of subregulation (6) or (7) in relation to a decision does not affect the validity of the decision. (9) Application may be made to the Administrative Review Tribunal for review of a reviewable decision. > Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act. ## Part 11—Transitional provisions ### Division 11.1—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1) #### Subdivision A—Preliminary #### 11.1 Interpretation (1) In this Division: > 2010 Amendment Regulations means the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1) as in force immediately before 1 July 2014. > approved transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010: (a) was a diagnostic good for in vitro use; and (b) was declared not to be a medical device under subsection 41BD(3) of the Act; and (c) was: (i) exempt from listing or registration under Part 3‑2 of the Act because item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applied to the device; or (ii) covered by an approval under paragraph 19(1)(b) of the Act; or (iii) a device for which an application for approval under paragraph 19(1)(b) of the Act had been made but not finally determined. > diagnostic good for in vitro use has the same meaning as in the Therapeutic Goods Regulations 1990 as in force on 30 June 2010. > exempt transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010: (a) was a diagnostic good for in vitro use; and (b) was declared not to be a medical device under subsection 41BD(3) of the Act; and (c) was exempt from listing or registration under Part 3‑2 of the Act; and (d) was not a device to which item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applied. > listed or registered transitional device means an IVD medical device (other than an in‑house IVD medical device) that, immediately before 1 July 2010: (a) was a diagnostic good for in vitro use; and (b) was declared not to be a medical device under subsection 41BD(3) of the Act; and (c) was: (i) listed or registered under Part 3‑2 of the Act; or (ii) a device for which an effective application for listing or registration under Part 3‑2 of the Act had been made but not finally determined. > transitional device means: (a) a Class 1 in‑house IVD medical device that is in existence before 1 July 2017; or (b) a Class 2 in‑house IVD medical device that is in existence before 1 July 2017; or (c) a Class 3 in‑house IVD medical device that is in existence before 1 July 2017; or (d) a Class 4 in‑house IVD medical device that is in existence before 1 July 2016; or (e) a listed or registered transitional device; or (f) an approved transitional device; or (g) an exempt transitional device. > transitional period means: (a) for a transitional device that is not an in‑house IVD medical device—the period starting on 1 July 2014 and ending immediately before the transition day for the device; and (b) for a transitional device that is an in‑house IVD medical device—the period starting on the later of: (i) 1 July 2014; and (ii) the day the device comes into existence; and ending immediately before the transition day for the device. > transition day, for a transitional device, means the day on which Schedule 1 to the 2010 Amendment Regulations starts to apply, for all purposes, in relation to the device. Meaning of finally determined (2) For this Division, an application is finally determined at the first time both the following conditions are met: (a) a decision has been made not to grant the application; (b) there is no longer any possibility of a change in the outcome of the decision. (3) For paragraph (2)(b), the possibility of a discretion being exercised after the period has ended, to extend the period for seeking review by a court or tribunal of the decision or for starting other proceedings (including appeals) arising out of the application, decision or review, is not to be considered. References to including a device in the Register (4) In this Division, a reference to including a device in the Register is a reference to including the device in the Register under Chapter 4 of the Act. #### 11.2 Application of 2010 Amendment Regulations (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device as set out in Subdivisions C to F of this Division unless: (a) the device was included in the Register before 1 July 2014; or (b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date. (2) To avoid doubt, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply, for all purposes, on and after 1 July 2014 in relation to: (a) a transitional device covered by paragraph (1)(a); and (b) a transitional device covered by paragraph (1)(b); and (c) an IVD medical device that is not a transitional device. #### Subdivision B—General provisions relating to transitional devices #### 11.3 Application of this Subdivision This Subdivision applies in relation to a transitional device unless: (a) the device was included in the Register before 1 July 2014; or (b) an effective application for including the device in the Register was made before 1 July 2014 and the application was finally determined before that date. #### 11.4 Transitional devices exempted from requirement to be included in the Register (1) For paragraph 41HA(1)(b) of the Act, a transitional device is exempt from the operation of Division 3 of Part 4‑11 of the Act during the transitional period for the device. (2) Subregulation 7.1(3) does not apply in relation to a transitional device during the transitional period for the device. (3) Regulation 3.10 does not apply in relation to a transitional device, during the transitional period for the device, for a purpose connected with: (a) an application for a conformity assessment certificate in respect of the device; or (b) issuing a conformity assessment certificate in respect of the device; or (c) an application for including the device in the Register; or (d) including the device in the Register. #### 11.5 Essential principles for transitional devices (1) For section 41CA of the Act, the essential principles set out in clauses 3 and 6 of Schedule 1 to these Regulations, as in force immediately before 1 July 2010, are prescribed for a transitional device during the transitional period for the device, for a purpose other than a purpose mentioned in subregulation (2). (2) Regulation 2.1 and Schedule 1 to these Regulations as in force on and after 1 July 2010 apply in relation to a transitional device for a purpose connected with: (a) an application for a conformity assessment certificate in respect of the device; or (b) issuing a conformity assessment certificate in respect of the device; or (c) an application for including the device in the Register; or (d) including the device in the Register; and not for any other purpose, during the transitional period for the device. #### Subdivision C—Listed or registered transitional devices and exempt transitional devices #### 11.6 Application of this Subdivision This Subdivision applies in relation to the following devices: (a) a listed or registered transitional device; (b) an exempt transitional device. #### 11.7 Application of 2010 Amendment Regulations—certain purposes The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, on and after 1 July 2014, for purposes connected with: (a) an application for a conformity assessment certificate in respect of the device; or (b) issuing a conformity assessment certificate in respect of the device; or (c) an application for including the device in the Register; or (d) including the device in the Register. #### 11.8 Application of 2010 Amendment Regulations—conformity assessment certificate required and applied for before 1 September 2014 (1) This regulation applies in relation to the device if: (a) a conformity assessment certificate is required under section 41EA of the Act before an effective application for including the device in the Register may be made; and (b) an effective application for a conformity assessment certificate in respect of the device is made before 1 September 2014. Certificate issued and inclusion application made before 1 July 2015—device included in Register (2) If: (a) a conformity assessment certificate in respect of the device is issued before 1 June 2015; and (b) an effective application for including the device in the Register is made before 1 July 2015; and (c) the device is included in the Register; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register. Certificate issued and inclusion application made before 1 July 2015—device not included in Register (3) If: (a) a conformity assessment certificate in respect of the device is issued before 1 June 2015; and (b) an effective application for including the device in the Register is made before 1 July 2015; and (c) the application for including the device in the Register is finally determined; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for including the device in the Register is finally determined. Certificate issued but inclusion application not made before 1 July 2015 (4) If: (a) a conformity assessment certificate in respect of the device is issued before 1 June 2015; and (b) an effective application for including the device in the Register is not made before 1 July 2015; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2015. Certificate issued on or after 1 June 2015 and inclusion application made within 30 days—device included in Register (5) If: (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2015; and (b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and (c) the device is included in the Register; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register. Certificate issued on or after 1 June 2015 and inclusion application made within 30 days—device not included in Register (6) If: (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2015; and (b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and (c) the application for including the device in the Register is finally determined; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on the day the application for including the device in the Register is finally determined. Certificate issued on or after 1 June 2015 but inclusion application not made within 30 days (7) If: (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2015; and (b) an effective application for including the device in the Register is not made within 30 days after the day the certificate is issued; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, 30 days after the day the certificate is issued. Certificate application finally determined and certificate not issued (8) If the application for the conformity assessment certificate is finally determined, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for the certificate is finally determined. #### 11.9 Application of 2010 Amendment Regulations—conformity assessment certificate required but not applied for before 1 September 2014 If: (a) a conformity assessment certificate is required under section 41EA of the Act before an effective application for including the device in the Register may be made; and (b) an effective application for a conformity assessment certificate in respect of the device is not made before 1 September 2014; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 September 2014. #### 11.10 Application of 2010 Amendment Regulations—conformity assessment certificate not required (1) This regulation applies in relation to the device if a conformity assessment certificate is not required under section 41EA of the Act before an effective application for including the device in the Register may be made. Inclusion application made before 1 July 2015—device included in Register (2) If: (a) an effective application for including the device in the Register is made before 1 July 2015; and (b) the device is included in the Register; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register. Inclusion application made before 1 July 2015—device not included in Register (3) If: (a) an effective application for including the device in the Register is made before 1 July 2015; and (b) the application for including the device in the Register is finally determined; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for including the device in the Register is finally determined. Inclusion application not made before 1 July 2015 (4) If an effective application for including the device in the Register is not made before 1 July 2015, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2015. #### 11.11 Cancellation of listing or registration If a listed or registered transitional device is listed or registered under Part 3‑2 of the Act immediately before 1 July 2014, the listing or registration is taken to be cancelled on the transition day for the device. #### Subdivision D—Approved transitional devices #### 11.12 Application of this Subdivision This Subdivision applies in relation to an approved transitional device. #### 11.13 Application of 2010 Amendment Regulations—certain purposes The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to an approved transitional device, on and after 1 July 2014, for purposes connected with: (a) an application for a conformity assessment certificate in respect of the device; or (b) issuing a conformity assessment certificate in respect of the device; or (c) an application for including the device in the Register; or (d) including the device in the Register. #### 11.14 Application of 2010 Amendment Regulations—all purposes The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to an approved transitional device, for all purposes, on and after: (a) if the device is covered by subparagraph (c)(i) of the definition of approved transitional device in subregulation 11.1(1)—the day the device ceases to be a device to which item 3 of Schedule 5A to the Therapeutic Goods Regulations 1990 applies; and (b) if the device is covered by subparagraph (c)(ii) of the definition of approved transitional device in subregulation 11.1(1)—the day the approval for the device ceases to have effect; and (c) if the device is covered by subparagraph (c)(iii) of the definition of approved transitional device in subregulation 11.1(1): (i) if approval is given for the device under paragraph 19(1)(b) of the Act—the day the approval ceases to have effect; and (ii) in any other case—the day the application for approval is finally determined. #### Subdivision E—Class 4 in‑house IVD medical devices #### 11.15 Application of this Subdivision This Subdivision applies in relation to a transitional device that is a Class 4 in‑house IVD medical device. #### 11.16 Application of 2010 Amendment Regulations—certain purposes The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after the later of the following days: (a) 1 July 2014; (b) the day on which the device comes into existence; for purposes connected with: (c) an application for a conformity assessment certificate in respect of the device; or (d) issuing a conformity assessment certificate in respect of the device; or (e) an application for including the device in the Register; or (f) including the device in the Register. #### 11.17 Application of 2010 Amendment Regulations—conformity assessment certificate applied for before 1 July 2016 (1) This regulation applies in relation to the device if an application for a conformity assessment certificate in respect of the device is made before 1 July 2016. Certificate issued and inclusion application made before 1 July 2017—device included in Register (2) If: (a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and (b) an effective application for including the device in the Register is made before 1 July 2017; and (c) the device is included in the Register; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register. Certificate issued and inclusion application made before 1 July 2017—device not included in Register (3) If: (a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and (b) an effective application for including the device in the Register is made before 1 July 2017; and (c) the application for including the device in the Register is finally determined; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application for including the device in the Register is finally determined. Certificate issued but inclusion application not made before 1 July 2017 (4) If: (a) a conformity assessment certificate in respect of the device is issued before 1 June 2017; and (b) an effective application for including the device in the Register is not made before 1 July 2017; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017. Certificate issued on or after 1 June 2017 and inclusion application made within 30 days—device included in Register (5) If: (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and (b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and (c) the device is included in the Register; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register. Certificate issued on or after 1 June 2017 and inclusion application made within 30 days—device not included in Register (6) If: (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and (b) an effective application for including the device in the Register is made no later than 30 days after the day the certificate is issued; and (c) the application for including the device in the Register is finally determined; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on the day the application for including the device in the Register is finally determined. Certificate issued on or after 1 June 2017 and inclusion application not made within 30 days (7) If: (a) a conformity assessment certificate in respect of the device is issued on or after 1 June 2017; and (b) an effective application for including the device in the Register is not made within 30 days after the day the certificate is issued; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, 30 days after the day the certificate is issued. (8) If the amendments made by Schedule 1 to the 2010 Amendment Regulations do not apply in relation to the device, for all purposes, under any of subregulations (2) to (7) of this regulation, then the amendments apply in relation to the device under regulation 11.18. #### 11.18 Application of 2010 Amendment Regulations—devices not covered by regulation 11.17 (1) This regulation applies in relation to the device if the amendments made by Schedule 1 to the 2010 Amendment Regulations do not apply in relation to the device, for all purposes, under any of subregulations 11.17(2) to (7). > Note 1: This regulation will apply, for example, in relation to a device if an application for a conformity assessment certificate is not made in respect of the device before 1 July 2016. > Note 2: The amendments made by Schedule 1 to the 2010 Amendment Regulations are affected by amendments made by Part 1 of Schedule 1 to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. Regulation 11.25 deals with the application of those 2015 amendments. Inclusion application made before 1 July 2017—device included in Register (2) If: (a) an effective application for including the device in the Register is made before 1 July 2017; and (b) the device is included in the Register; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the device is included in the Register. Inclusion application made before 1 July 2017—application withdrawn or finally determined (3) If: (a) an effective application for including the device in the Register is made before 1 July 2017; and (b) the application is withdrawn or is finally determined; the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after the day the application is withdrawn or is finally determined (as the case may be). Inclusion application not made before 1 July 2017 (4) If an effective application for including the device in the Register is not made before 1 July 2017, the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017. #### Subdivision F—Class 1, 2 and 3 in‑house IVD medical devices #### 11.20 Application of this Subdivision This Subdivision applies in relation to a transitional device that is any of the following: (a) a Class 1 in‑house IVD medical device; (b) a Class 2 in‑house IVD medical device; (c) a Class 3 in‑house IVD medical device. #### 11.21 Application of 2010 Amendment Regulations for all purposes The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device, for all purposes, on and after 1 July 2017. > Note: The amendments made by Schedule 1 to the 2010 Amendment Regulations are affected by amendments made by Part 2 of Schedule 1 to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. Regulation 11.26 deals with the application of those 2015 amendments. ### Division 11.2—Transitional provisions relating to joint replacements #### 11.22A Purpose of this Division This Division includes transitional provisions relating to: (a) the Therapeutic Goods (Medical Devices) Amendment Regulation 2012 (No. 1); and (b) the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015. #### 11.23 Refund of fees in relation to inclusion of certain devices in the Register as Class III medical devices (1) This regulation applies in relation to an implantable medical device if: (a) the device is of the kind referred to in subregulation 11.22(1) of the old Regulations; and (b) the device is not a joint replacement medical device; and (c) an application to include the device in the Register as a Class III medical device was made on or after 1 July 2012 and before the commencement of the amending Regulation. > Note: Subregulation 11.22(1) of the old Regulations referred to an implantable medical device that is intended by the manufacturer to be any of the following: (a) a total or partial shoulder joint replacement; (b) a total or partial hip joint replacement; (c) a total or partial knee joint replacement. (2) The Secretary may refund any fee paid in relation to the application. (3) If any annual charge has been paid in respect of the inclusion of the device in the Register as a Class III medical device, the Secretary may refund the difference between the annual charge paid and the annual charge that would have been payable in respect of the inclusion of the device in the Register as a Class IIb medical device. (4) In this regulation: > amending Regulation means the Therapeutic Goods (Medical Devices) Amendment (Joint Replacements) Regulation 2015. > old Regulations means these Regulations as in force immediately before the commencement of the amending Regulation. ### Division 11.3—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015 #### 11.24 Definitions In this Division: > 2010 Amendment Regulations has the meaning given by regulation 11.1. > 2015 Amendment Regulations means the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015. > commencement day means the day this Division commences. > transitional device has the meaning given by regulation 11.1. > transition day has the meaning given by regulation 11.1. #### 11.25 Application of 2015 Amendment Regulations—transitional Class 4 in‑house IVD medical devices (1) This regulation applies in relation to a transitional device that is a Class 4 in‑house IVD medical device. (2) The amendments made by Part 1 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device, for a purpose connected with a matter mentioned in any of paragraphs 11.16(c) to (f), on and after the later of the following days: (a) the commencement day; (b) the day on which the device comes into existence. (3) The amendments made by Part 1 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device, for all purposes, on and after the later of the following days: (a) the commencement day; (b) the transition day for the device. #### 11.26 Application of 2015 Amendment Regulations etc.—transitional Class 1, 2 and 3 in‑house IVD medical devices (1) This regulation applies in relation to a transitional device that is a Class 1 in‑house IVD medical device, Class 2 in‑house IVD medical device or Class 3 in‑house IVD medical device. (2) Subject to subregulations (3) and (4), the amendments made by Part 2 of Schedule 1 to the 2015 Amendment Regulations apply in relation to the device for all purposes, on and after 1 July 2017. (3) If, before the commencement day, the manufacturer of the device has notified the Secretary of the matters referred to in subclause 1.2(1) of Part 6A of Schedule 3 (as inserted by Schedule 1 to the 2010 Amendment Regulations), the manufacturer is taken to have complied with the notification requirements in subclauses 6A.2(1) and (2) and paragraph (3)(a) of Part 6A of Schedule 3 in relation to the devices covered by the notification. (4) If: (a) on or after the commencement day and before 1 July 2017, the manufacturer of the device notifies the Secretary of the Class 1, 2 or 3 in‑house IVD medical devices being manufactured; and (b) the notification is in accordance with subclauses 6A.2(2) and (3) of Part 6A of Schedule 3; the manufacturer is taken to have complied with the notification requirements in subclauses 6A.2(1) and (2) and paragraph (3)(a) of Part 6A of Schedule 3 in relation to the devices covered by the notification. ### Division 11.4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 #### 11.27 Application (1) The amendments made by items 1, 12 and 13 of Schedule 3 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to medical devices included in the Register on or after the day that Schedule commences if the application for inclusion in the Register was made on or after that day. ### Division 11.5—Transitional provisions relating to the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017 #### 11.28 Definitions In this Division: > amending regulations means the Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017. > finally determined has the meaning given by subregulation 11.29(5). > inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences. > pre‑commencement entry: an entry of a kind of medical device in the Register is a pre‑commencement entry if that kind of medical device is included in the Register because of an application made before 1 December 2018 (whether the inclusion day for the entry occurred before, on or after 1 December 2018). > unique product identifier, in relation to a medical device, means the unique product identifier given to the device by its manufacturer to identify the device and any variants. #### 11.29 Surgical mesh—application of amendments Applications and entries other than pre‑commencement entries (1) The amendment made by Part 1 of Schedule 1 to the amending regulations applies on and after 1 December 2018 in relation to the following: (a) an application for a kind of medical device to be included in the Register, if the application is made on or after 1 December 2018; (b) an entry of a kind of medical device in the Register that is not a pre‑commencement entry. Pre‑commencement entries (2) Subject to subregulations (3) and (4A), the amendment made by Part 1 of Schedule 1 to the amending regulations applies in relation to a pre‑commencement entry of a kind of medical device on and after: (a) if medical devices of that kind are urogynaecological mesh—1 December 2020; or (b) otherwise—1 December 2021. (3) The amendment does not apply in relation to the pre‑commencement entry before the day mentioned in subregulation (4) if: (a) the person applies under the Act: (i) on or after the inclusion day for the pre‑commencement entry; and (ii) on or after the commencement of Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021; and (iii) before 1 December 2021; to have a kind of medical device included in the Register; and (b) that kind of medical device is surgical mesh (other than urogynaecological mesh). (4) For the purposes of subregulation (3), the day is the day after the day on which: (a) the person withdraws the application mentioned in paragraph (3)(a); or (b) that application lapses under section 41FK of the Act; or (c) that application is finally determined. (4A) The amendment referred to in subregulation (2) does not apply in relation to the pre‑commencement entry before the day applicable under subregulation (4B) if: (a) the kind of medical device covered by that entry is surgical mesh (other than urogynaecological mesh); and (b) the person has not made an application of the kind covered by subregulation (3) (as in force before or after the commencement of this subregulation) before 1 December 2021; and (c) on or after 1 July 2020 and before 1 December 2021, the person made an application under section 41EB of the Act for a conformity assessment certificate in respect of a kind of medical device that is surgical mesh (other than urogynaecological mesh); and (d) the person has not withdrawn that application before 1 December 2021; and (e) that application has not lapsed under section 41EG of the Act before 1 December 2021; and (f) if the conformity assessment certificate was issued before 1 December 2021—the period of 6 months beginning on the day of the issue of the certificate has not ended before 1 December 2021. (4B) For the purposes of subregulation (4A), the day applicable under this subregulation is the later of 1 December 2021 and the day after the earliest of the following days: (a) the day the person withdraws the application mentioned in paragraph (4A)(c); (b) the day that application lapses under section 41EG of the Act; (c) in the case of a decision to refuse to issue the conformity assessment certificate and where there is no longer any possibility of a change in the outcome of that decision—the first day on which there is no longer that possibility; (d) if the conformity assessment certificate was issued: (i) if, at the end of the period of 6 months beginning on the day of the issue of the certificate, the person has not made an application under the Act to have the kind of medical device referred to in paragraph (4A)(c) included in the Register—the last day of that 6‑month period; or (ii) if, before the end of the period of 6 months beginning on the day of the issue of the certificate, the person has made an application under the Act to have the kind of medical device referred to in paragraph (4A)(c) included in the Register—the relevant day under subregulation (4C). (4C) For the purposes of subparagraph (4B)(d)(ii), the relevant day is: (a) the day the person withdraws the application mentioned in that subparagraph; or (b) the day that application lapses under section 41FK of the Act; or (c) the day on which that application is finally determined; whichever occurs first. (5) For the purposes of this regulation, an application is finally determined at the first time both the following conditions are met: (a) a decision has been made whether or not to grant the application; (b) there is no longer any possibility of a change in the outcome of the decision. #### 11.31 Patient information—application of amendments Devices other than urogynaecological mesh (1) The amendments made by Part 2 of Schedule 1 to the amending regulations apply on and after the day mentioned in column 1 of an item of the following table: (a) to the extent that the amendments relate to a patient implant card or patient information leaflet mentioned in column 2 of the item; and (b) in relation to: (i) an application for a kind of medical device to be included in the Register; or (ii) an entry of a kind of medical device in the Register; mentioned in column 3 of the item; if devices of that kind are not urogynaecological mesh. ```html <table cellspacing="0" cellpadding="0" style="margin-left:0.7pt; border-collapse:collapse"><thead><tr><td colspan="4" style="width:399.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Entries and applications relating to medical devices other than urogynaecological mesh</td></tr><tr><td style="width:24.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:84.2pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 1Day amendments start applying</td><td style="width:84.2pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 2Card or leaflet</td><td style="width:174.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 3Application or entry</td></tr></thead><tbody><tr><td style="width:24.45pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:84.2pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1 December 2018</td><td style="width:84.2pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">patient information leaflet</td><td style="width:174.35pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">(a) an application made on or after 1 December 2018; or(b) an entry that is not a pre‑commencement entry</td></tr><tr><td style="width:24.45pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:84.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1 December 2020</td><td style="width:84.2pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">patient implant card</td><td style="width:174.35pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">(a) an application made on or after 1 December 2020; or(b) an entry that is not a pre‑commencement entry</td></tr><tr><td style="width:24.45pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">3</td><td style="width:84.2pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1 December 2021</td><td style="width:84.2pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">(a) patient implant card; or(b) patient information leaflet</td><td style="width:174.35pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">a pre‑commencement entry</td></tr></tbody></table> ``` Urogynaecological mesh (2) The amendments made by Part 2 of Schedule 1 to the amending regulations apply on and after the day mentioned in column 1 of an item of the following table in relation to: (a) an application for a kind of medical device to be included in the Register; or (b) an entry of a kind of medical device in the Register; mentioned in column 2 of the item, if devices of that kind are urogynaecological mesh. ```html <table cellspacing="0" cellpadding="0" style="margin-left:0.7pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:400.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Entries and application relating to urogynaecological mesh</td></tr><tr><td style="width:23.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Item</td><td style="width:84.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 1Day amendments start applying</td><td style="width:269.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">Column 2Application or entry</td></tr></thead><tbody><tr><td style="width:23.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1</td><td style="width:84.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1 December 2018</td><td style="width:269.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">(a) an application made on or after 1 December 2018; or(b) an entry that is not a pre‑commencement entry</td></tr><tr><td style="width:23.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">2</td><td style="width:84.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">1 December 2019</td><td style="width:269.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top">a pre‑commencement entry</td></tr></tbody></table> ``` ### Division 11.6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017 #### 11.32 Definitions In this Division: > Amendment Regulations means the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017. > commencement day means the day on which Part 3 of Schedule 4 to the Amendment Regulations commences. #### 11.33 Application—statements in relation to exempt devices The amendments of regulations 7.2 and 8.2 of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to the use of a medical device in or on a person on or after the commencement day. ### Division 11.7—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 #### 11.34 Application of amendments The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a medical device imported into Australia: (a) on or after the commencement of this regulation; or (b) during the 12 months ending immediately before that commencement, if the device was held under the direct control of the sponsor immediately before that commencement. ### Division 11.8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018 #### 11.35 Application—regulation 4.3G (conditions applying automatically to conformity assessment certificates) Regulation 4.3G applies to a conformity assessment certificate issued before, on or after 1 July 2018. #### 11.36 Application—regulation 5.13 (conditions applying automatically to medical devices included in the Register) Regulation 5.13 applies to a kind of medical device included in the Register before, on or after 1 July 2018. ### Division 11.9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 #### 11.37 Application of table item 1.5 in Part 1 of Schedule 5 (1) Table item 1.5 in Part 1 of Schedule 5, as amended by the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018, applies in relation to applications made on or after 1 July 2018. (2) If, on or after 1 July 2018 and before the commencement of Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018, a person: (a) applied for the inclusion in the Register of a Class I medical device intended by the manufacturer to be for export only; and (b) paid the fee prescribed in relation to that application by table item 1.5 in Part 1 of Schedule 5 to these Regulations as in force before that commencement; the Secretary must refund to the person the difference between the fee paid and the fee prescribed in relation to the application by that table item as in force after that commencement. ### Division 11.10—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 #### Subdivision A—Definitions #### 11.38 Definitions In this Division: > amending regulations means the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019. > finally determined: an application is finally determined at the first time both the following conditions are met: (a) a decision has been made whether or not to grant the application; (b) there is no longer any possibility of a change in the outcome of the decision. > unique product identifier, in relation to a medical device, means the unique product identifier given to the device by its manufacturer to identify the device and any variants. #### Subdivision B—Reclassification of medical devices #### 11.39 Definitions In this Subdivision: > inclusion day for an entry of a kind of transitional medical device in the Register means the day on which the inclusion of that kind of device in the Register commences. > pre‑commencement entry: an entry of a kind of transitional medical device in the Register is a pre‑commencement entry if that kind of medical device is included in the Register because of an application made before 25 November 2021 (whether the inclusion day for the entry occurred before, on or after 25 November 2021). > transitional AIMD device means a transitional medical device of a kind mentioned in column 1 of item 2 of the table in the definition of transitional medical device. > transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if: (a) the medical device is, immediately before 25 November 2021, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or (b) on 25 November 2021: (i) the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and (ii) the application had not been finally determined. ```html <table cellspacing="0" cellpadding="0" style="width:411.1pt; border-collapse:collapse"><thead><tr><td colspan="3" style="width:400.4pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Transitional medical device</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"></td><td style="width:180.7pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 1</td><td style="width:152.3pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Column 2</td></tr><tr><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Item</td><td style="width:180.7pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Kind of medical device</td><td style="width:152.3pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class of medical device or application</td></tr></thead><tbody><tr><td style="width:46pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">1</td><td style="width:180.7pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in subclause 3.4(4B) of Schedule 2</td><td style="width:152.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class IIb</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">2</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">an active implantable medical device</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class AIMD</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">3</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in clause 5.10 of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class I or Class IIa</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">4</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in clause 5.11 of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class I, Class IIa or Class IIb</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">5</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in subclause 4.2(4) of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class IIa or Class IIb</td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">6</td><td style="width:180.7pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">a medical device of a kind described in subclause 3.2(3A) of Schedule 2</td><td style="width:152.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top">Class IIa or Class IIb</td></tr></tbody></table> ``` #### 11.40 Transitional medical devices—application of amendments Applications and entries other than for transitional medical devices (1) The amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply on and after 25 November 2021 in relation to the following: (a) an application for a kind of medical device to be included in the Register that is made on or after 25 November 2021; (b) a kind of medical device that is included in the Register as a result of such an application. Applications and entries for transitional medical devices (2) Subject to subregulations (3) and (5), the amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply in relation to a transitional medical device on and after: (a) for a transitional AIMD device—1 November 2024; and (b) for a transitional medical device other than a transitional AIMD device—1 July 2029. (3) The amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, do not apply in relation to a transitional medical device before the day applicable under subregulation (4) if: (a) a person applies under the Act: (i) on or after the inclusion day for the entry of the transitional medical device; and (ii) on or after 25 November 2021; and (iii) before the day mentioned in paragraph (2)(a) or (b) (as the case may be) for the transitional medical device; to have a kind (the new kind) of medical device included in the Register; and (b) the person gives to the Secretary a notice under regulation 11.41 in relation to the transitional medical device; and (c) the unique product identifier of the device of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice. (4) For the purposes of subregulation (3), the day is the day after the day on which: (a) the person withdraws the application mentioned in paragraph (3)(a); or (b) that application lapses under section 41FK of the Act; or (c) that application is finally determined. (5) If: (a) a person is required under regulation 11.41 to give a notice to the Secretary in relation to a transitional medical device; and (b) the person fails to give the notice in accordance with that regulation before the later of: (i) 25 May 2022; and (ii) the day occurring 2 months after the inclusion day for the entry of the transitional medical device; then the amendments made by Parts 1 to 6 of Schedule 1 to the amending regulations, and the amendments made by Part 4 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply in relation to the transitional medical device on and after the later of those days. #### 11.41 Transitional medical devices—Secretary must be notified of unique product identifiers of devices supplied under pre‑commencement entries (1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if: (a) a kind of medical device is included in the Register in relation to the person; and (b) the entry of that kind of medical device is a pre‑commencement entry; and (c) a medical device of that kind is a transitional medical device. (2) The notice must: (a) be in writing; and (b) state: (i) the unique device number assigned to that kind of device under section 41FL of the Act; and (ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and (c) be given to the Secretary before the later of: (i) 25 May 2022; and (ii) the day occurring 2 months after the inclusion day for the entry of the transitional medical device. #### 11.42 Transitional medical devices—selecting applications for auditing Subregulation 5.3(1) does not apply to an application for inclusion of a kind of medical device in the Register as a Class III medical device if the application is for a transitional AIMD device. #### 11.43 Waiver of certain application fees (1) This regulation applies in relation to an application to include in the Register a transitional AIMD device as a Class III medical device. (2) The Secretary must waive the fee set out in paragraph (b) of column 2 in item 1.5 of the table in Part 1 of Schedule 5 in relation to the application. (3) This regulation ceases to have effect at the end of 24 November 2022. #### Subdivision C—Programmed or programmable medical device or software that is a medical device #### 11.44 Definitions In this Subdivision: > inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences. > transitional kind of medical device means a kind of medical device included in the Register because of an application made before 25 February 2021 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day). #### 11.45 Programmed or programmable medical device or software that is a medical device—classification rules Applications and entries other than a transitional kind of medical device (1) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply on and after 25 February 2021 in relation to the following: (a) an application for a kind of medical device to be included in the Register that is made on or after 25 February 2021; (b) a kind of medical device that is included in the Register as a result of such an application. Transitional kind of medical device (2) Subject to subregulations (3), (4A) and (5), clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply in relation to a transitional kind of medical device on and after 1 November 2024. (3) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, do not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4) if: (a) the person applies under the Act: (i) on or after the inclusion day for the entry of the transitional kind of medical device; and (ii) on or after 25 February 2021; and (iii) before 1 November 2024; to have a kind (the new kind) of medical device included in the Register; and (b) the person gives to the Secretary a notice under regulation 11.46 in relation to the transitional kind of medical device; and (c) the unique product identifier of the devices of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice. (4) For the purposes of subregulation (3), the day is the day after the day on whichever of the following events occurs first: (a) the person withdraws the application mentioned in paragraph (3)(a); (b) that application lapses under section 41FK of the Act; (c) that application is finally determined. (4A) Clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, do not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4B) if: (a) on or after 25 February 2021, and before 1 November 2024, the person makes an application under section 41EB of the Act for a conformity assessment certificate in respect of a kind (the new kind) of medical device; and (b) the person has not, before 1 November 2024, made an application under the Act to have the new kind of medical device included in the Register; and (c) the person has not withdrawn the conformity assessment certificate application before 1 November 2024; and (d) the conformity assessment certificate application has not lapsed under section 41EG of the Act before 1 November 2024; and (e) the person gives the Secretary a notice under regulation 11.46 in relation to the transitional kind of medical device; and (f) the unique product identifier of the new kind of medical device contained in the conformity assessment certificate application is the unique product identifier, or one of the unique product identifiers, stated in the notice. (4B) For the purposes of subregulation (4A), the applicable day is the later of 1 November 2024 and the day after the earliest of the following days: (a) the day the person withdraws the conformity assessment certificate application; (b) the day that application lapses under section 41EG of the Act; (c) in the case of a decision to not issue the conformity assessment certificate and where there is no longer any possibility of a change in the outcome of that decision—the first day on which there is no longer that possibility; (d) in the case of a decision to issue the conformity assessment certificate: (i) if, at the end of the period of 6 months beginning on the day of the issue of the certificate, the person has not made an application under the Act to have the new kind of medical device included in the Register—the last day of that 6‑month period; or (ii) if, before the end of the period of 6 months beginning on the day of the issue of the certificate, the person has made an application under the Act to have the new kind of medical device included in the Register—the day applicable under subregulation (4C). (4C) For the purposes of subparagraph (4B)(d)(ii), the applicable day is the day after the day on whichever of the following events occurs first: (a) the person withdraws the application mentioned in that subparagraph; (b) that application lapses under section 41FK of the Act; (c) that application is finally determined. (5) If: (a) a person is required under regulation 11.46 to give a notice to the Secretary in relation to a transitional kind of medical device; and (b) the person fails to give the notice in accordance with that regulation before the later of: (i) 25 August 2021; and (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device; then clauses 4.5 to 4.8 of Schedule 2, as added by Schedule 2 to the amending regulations, apply in relation to the transitional kind of medical device on and after the later of those days. #### 11.46 Secretary must be notified in relation to a transitional kind of medical device (1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (2) if: (a) a kind of medical device is included in the Register in relation to the person; and (b) the kind of medical device so included is a transitional kind of medical device; and (c) medical devices of that kind are programmed or programmable medical devices or software. (2) The notice must: (a) be in writing; and (b) state: (i) the unique device number assigned to that kind of device under section 41FL of the Act; and (ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and (c) be given to the Secretary before the later of: (i) 25 August 2021; and (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device. #### 11.47 Programmed or programmable medical device or software that is a medical device—essential principles (1) Clause 13B of Schedule 1, as inserted by Schedule 2 to the amending regulations, applies on and after 25 February 2021 in relation to the following: (a) an application for a kind of medical device to be included in the Register that is made on or after 25 February 2021; (b) a kind of medical device that is included in the Register as a result of such an application. (2) Clause 13B of Schedule 1, as inserted by Schedule 2 to the amending regulations, applies in relation to a transitional kind of medical device on and after 1 November 2024. #### Subdivision D—Personalised medical devices #### 11.48 Definitions In this Subdivision: > inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences. > transitional kind of medical device means a kind of medical device included in the Register because of an application made before 25 February 2021 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day). #### 11.49 Personalised medical devices—reports (1) Subregulation 10.3A(1), as inserted by Schedule 3 to the amending regulations, applies in relation to a custom‑made medical device that is manufactured on or after 25 February 2021. (2) Subregulation 10.3A(2), as inserted by Schedule 3 to the amending regulations, applies in relation to a custom‑made medical device that is imported into Australia on or after 25 February 2021. #### 11.50 Personalised medical devices—conformity assessment procedures (1) The amendments of clause 7.2 of Schedule 3 made by Schedule 3 to the amending regulations apply in relation to a custom‑made medical device that is manufactured on or after 25 February 2021. (2) The repeal and substitution of subclause 7.6(2) of Schedule 3 made by Schedule 3 to the amending regulations applies in relation to a medical device that is manufactured on or after 25 February 2021. #### 11.51 Personalised medical devices—exemptions (2) Items 2.12 and 2.13 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, apply in relation to a custom‑made medical device that is manufactured on or after 25 February 2021, where the request from the health professional is made on or after that day. (3) Item 2.14 of the table in Part 2 of Schedule 4, as added by Schedule 3 to the amending regulations, applies in relation to a patient‑matched medical device if it is manufactured on or after 25 February 2021 and before 1 July 2029. #### 11.52 Personalised medical devices—classification rules Applications and entries other than a transitional kind of medical device (1) Clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies on and after 25 February 2021 in relation to the following: (a) an application for a kind of medical device to be included in the Register that is made on or after 25 February 2021; (b) a kind of medical device that is included in the Register as a result of such an application. Transitional kind of medical device (2) Subject to subregulations (3) and (5), clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies in relation to a transitional kind of medical device on and after 1 July 2029. (3) Clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, does not apply in relation to a transitional kind of medical device before the day applicable under subregulation (4) if: (a) the person applies under the Act: (i) on or after the inclusion day for the entry of the transitional kind of medical device; and (ii) on or after 25 February 2021; and (iii) before 1 July 2029; to have a kind (the new kind) of medical device included in the Register; and (b) the person gives to the Secretary a notice under regulation 11.53 in relation to the transitional kind of medical device; and (c) the unique product identifier of the devices of the new kind is the unique product identifier, or one of the unique product identifiers, stated in the notice. (4) For the purposes of subregulation (3), the day is the day after the day on whichever of the following events occurs first: (a) the person withdraws the application mentioned in paragraph (3)(a); (b) that application lapses under section 41FK of the Act; (c) that application is finally determined. (5) If: (a) a person is required under regulation 11.53 to give a notice to the Secretary in relation to a transitional kind of medical device; and (b) the person fails to give the notice in accordance with that regulation before the later of: (i) 25 August 2021; and (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device; then clause 5.4 of Schedule 2, as substituted by Schedule 3 to the amending regulations, applies in relation to the transitional kind of medical device on and after the later of those days. #### 11.53 Secretary must be notified in relation to a transitional kind of medical device (1) For the purposes of subsection 41FN(5A) of the Act, a person must give to the Secretary a notice in accordance with subregulation (5) if: (a) a kind of medical device is included in the Register in relation to the person; and (b) the kind of medical device so included is a transitional kind of medical device; and (c) medical devices of that kind are medical devices that are covered by subregulation (2), (3) or (4). (2) This subregulation covers a medical device that is intended by the manufacturer to be used to record patient images that are to be used for either or both of the following: (a) the diagnosis or monitoring of a disease, injury or disability; (b) the investigation of the anatomy or of a physiological process; where the images are to be acquired through a method that relies on energy outside the visible spectrum. (3) This subregulation covers a medical device that is an anatomical model (whether physical or virtual) that is intended by the manufacturer to be used for either or both of the following: (a) the diagnosis or monitoring of a disease, injury or disability; (b) the investigation of the anatomy or of a physiological process. (4) This subregulation covers a programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to generate a virtual anatomical model that is to be used for either or both of the following: (a) the diagnosis or monitoring of a disease, injury or disability; (b) the investigation of the anatomy or of a physiological process. (5) The notice must: (a) be in writing; and (b) state: (i) the unique device number assigned to that kind of device under section 41FL of the Act; and (ii) the unique product identifier given to each medical device (if any) of that kind that the person supplies in Australia; and (c) be given to the Secretary before the later of: (i) 25 August 2021; and (ii) the day occurring 2 months after the inclusion day for the entry of the transitional kind of medical device. #### Subdivision E—IVD companion diagnostics #### 11.54 IVD companion diagnostics Applications required to be audited (1) The amendment of paragraph 5.3(1)(j) by Schedule 4 to the amending regulations applies to applications made on or after 1 February 2020. Classification and kind of medical device (2) Despite the amendments made by Schedule 4 to the amending regulations on 1 February 2020, until 31 December 2028 those amendments: (a) do not affect the classification of a device covered by subregulation (3), (4) or (5); and (b) do not affect whether such a device is of the same kind as another device. (3) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was either a Class 4 in‑house IVD medical device or an IVD medical device other than an in‑house IVD medical device, and: (a) was included in the Register; or (b) was the subject of an application for inclusion in the Register that had not been finally determined. (4) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was either a Class 4 in‑house IVD medical device or an IVD medical device other than an in‑house IVD medical device, that: (a) was not included in the Register but was covered by a conformity assessment certificate having effect; or (b) was proposed to be covered by a conformity assessment certificate for which an application had been made but not finally determined. (5) This subregulation covers an IVD companion diagnostic that, immediately before 1 February 2020, was: (a) a Class 1 in‑house IVD medical device; or (b) a Class 2 in‑house IVD medical device; or (c) a Class 3 in‑house IVD medical device. (6) Subregulation (2) does not prevent the making and determination on or after 1 February 2020 and before 31 December 2028 of an application for inclusion in the Register of a device covered by subregulation (3), (4) or (5) in accordance with these Regulations as amended by Schedule 4 to the amending regulations. (7) Paragraph (h) of item 1.5 of the table in Part 1 of Schedule 5 does not apply to an application described in subregulation (6) of this regulation (made within the period described in that subregulation). > Note: This means that an application described in subregulation (6) can pass the preliminary assessment without payment of any fee. ### Division 11.11—Application provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 #### 11.55 System or procedure packs The amendments made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to a system or procedure pack that is manufactured on or after the commencement of that Part. #### 11.56 Period for notifying adverse events Paragraph 5.7(1)(d), as inserted by Schedule 3 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to information that a person becomes aware of on or after the commencement of that Schedule. #### 11.57 Class 4 in‑house IVD medical devices Item 2.10A of the table in Part 2 of Schedule 4, as inserted by Schedule 7 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to the following: (a) a Class 4 in‑house IVD medical device that is manufactured on or after the commencement of this regulation; (b) a Class 4 in‑house IVD medical device that is manufactured before that commencement and is intended by its manufacturer to be used on or after that commencement. ### Division 11.12—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021 #### 11.58 Application provisions Conformity assessment (6) The amendments made by Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 2) Regulations 2021 apply in relation to an application for a kind of medical device to be included in the Register that is made on or after the commencement of that Part. ### Division 11.13—Application, saving and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 #### 11.59 System or procedure packs Applications and entries other than a transitional kind of medical device (1) The amendments made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to the following: (a) an application for a kind of medical device to be included in the Register that is made on or after 25 November 2021; (b) a kind of medical device that is included in the Register as a result of such an application. Transitional kind of medical device (2) The amendments made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to a transitional kind of medical device on and after 25 November 2025. Exempt devices (3) The amendments made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, to the extent the amendments relate to a system or procedure pack covered by an item in Part 1 of Schedule 4, or by column 2 of an item in Part 2 of Schedule 4, to these Regulations, apply in relation to a system or procedure pack that is manufactured on or after 25 November 2025. Definitions (4) In this regulation: > inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences. > transitional kind of medical device means a kind of medical device included in the Register because of an application that was made before 25 November 2021 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day). #### 11.60 Reports about adverse events or occurrences for medical devices Subregulation 5.8A(1), as inserted by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act that is given to the Secretary on or after the commencement of that Part. #### 11.61 Patient implant cards and patient information leaflets (1) The amendments of Part 9 and of item 1.15 of the table in Part 1 of Schedule 5 made by Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an application for consent that is made on or after the commencement of those amendments. (2) The amendments of clauses 13A.1 to 13A.4 of Schedule 1 made by Part 3 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an implantable medical device, or an active implantable medical device, that is imported, supplied or exported on or after the commencement of that Part. (3) If: (a) on or after 1 January 2021 and before the commencement of this regulation, a person made an application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5 (as that item was in force before that commencement); and (b) the application was made solely in relation to the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1 (as those clauses were in force before that commencement); and (c) on or after 1 January 2021 and before the commencement of this regulation, the person paid the fee applicable in relation to the application under item 1.15 of the table in Part 1 of Schedule 5 (as that item was in force before that commencement); the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the application under regulation 9.1AA if the application had been made on the day on which this regulation commences. #### 11.62 Medical devices assembled or adapted at point of care Item 1.3B of the table in Part 1 of Schedule 4, as inserted by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to a medical device that is manufactured on or after the commencement of that item. #### 11.63 Patient‑matched medical devices Subregulation 7.1(8) and item 1.7 of Part 1 of Schedule 4, as added by Part 6 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, apply in relation to patient‑matched medical devices manufactured on or after the commencement of that item in the following: (a) the financial year in which that item commences; (b) each later financial year. #### 11.64 Surgical loan kits The amendment made by Part 7 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 applies on and after the commencement of that Part in relation to a surgical loan kit manufactured before, on or after that commencement. #### 11.66 Surgical mesh Regulations 11.29 and 11.30, as in force immediately before the commencement of Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, continue to apply on and after that commencement in relation to an application referred to in paragraph 11.29(3)(a) (as so in force) that was made before that commencement. ### Division 11.14—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 #### 11.67 Patient implant cards and patient information leaflets The amendments of clause 13A.1 of Schedule 1 made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to a medical device that is imported, supplied or exported on or after the commencement of that Part. ### Division 11.15—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022 #### 11.68 Fee for application for consent of Secretary (1) The amendments of Part 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 2) Regulations 2022 apply in relation to an application for consent that is made on or after the commencement of those amendments. (2) If: (a) on or after 1 January 2022 and before the commencement of this regulation, a person made an application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5; and (b) the application was made in relation to the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical device or devices; and (c) the reason for the medical device or devices not complying with one or more of those clauses was that the device or devices were affected by the EU transition (within the meaning of subregulation 9.1AA(3) of these Regulations); and (d) the application was made: (i) solely in relation to the application of one or more of those clauses; or (ii) also in relation to the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1, but not any other provision; and (e) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the application under item 1.15 of the table in Part 1 of Schedule 5; the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the application under regulation 9.1AA if the application had been made on the day on which this regulation commences. ### Division 11.16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 #### 11.69 Fee for application for consent of Secretary (1) The amendments of regulation 9.1AA made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 apply in relation to an application for consent that is made on or after the commencement of this regulation. (2) If: (a) on or after 1 January 2022 and before the commencement of this regulation, a person made an application of a kind covered by paragraph (a) or (b) of item 1.15 of the table in Part 1 of Schedule 5; and (b) the application was made in relation to the application of one or more of clauses 13.1 to 13.4 of Schedule 1 to the medical device or devices; and (c) the reason for the medical device or devices not complying with one or more of those clauses was that the device or devices were affected by the EU transition (within the meaning of subregulation 9.1AA(3) of these Regulations as in force at the commencement of this regulation); and (d) the application was made: (i) solely in relation to the application of one or more of those clauses; or (ii) also in relation to the application of either or both of clauses 13A.2 and 13A.3 of Schedule 1, but not any other provision; and (e) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the application under item 1.15 of the table in Part 1 of Schedule 5; the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the application under regulation 9.1AA if the application had been made on the day on which this regulation commences. #### 11.70 Exempt medical devices The amendment of Schedule 4 made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a medical device that is imported into Australia on or after the commencement of this regulation. ### Division 11.17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 #### 11.71 Clinical trials The amendments of item 2.3 of the table in Part 2 of Schedule 4 made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of a medical device on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement. ### Division 11.18—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 #### 11.72 Clinical trials (1) The amendments of subregulation 7.4(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement. (2) The amendment of Schedule 4 to these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 applies in relation to: (a) requests made on or after the commencement of that amendment to give information acquired before, on or after that commencement; and (b) things mentioned in regulation 7.4 of these Regulations done on or after that commencement; in relation to a clinical trial that began before, on or after that commencement. ### Division 11.19—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023 #### 11.73 Application of amendments The amendments of these Regulations made by Part 1 of Schedule 2 to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023 (other than the amendments of the Dictionary) apply in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024. ### Division 11.20—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024 #### 11.74 Definitions In this Division: > amending regulations means the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024. > finally determined: an application is finally determined at the first time both the following conditions are met: (a) a decision has been made whether or not to grant the application; (b) there is no longer any possibility of a change in the outcome of the decision. > inclusion day for an entry of a kind of medical device in the Register means the day on which the inclusion of that kind of device in the Register commences. > transitional medical device means a medical device of a kind: (a) that was, immediately before 1 July 2024: (i) included in the Register; and (ii) a kind of medical device to which clause 5.5 of Schedule 2 to these Regulations applied; and (b) that is, on 1 July 2024, a kind of a medical device to which clause 5.5 of Schedule 2 to these Regulations no longer applies. #### 11.75 Exemption for certain prescription spectacle lenses Item 1.4A of Part 1 of Schedule 4, as inserted by Part 2 of Schedule 1 to the amending regulations, applies in relation to medical devices imported into Australia, exported from Australia, or manufactured or supplied in Australia, on or after the commencement of that item. #### 11.76 Auditing of applications (1) The amendments of regulation 5.3 of these Regulations made by Part 2 of Schedule 2 to the amending regulations apply in relation to applications made on or after 1 July 2024. (2) The amendment of regulation 5.12 of these Regulations made by Part 2 of Schedule 2 to the amending regulations applies in relation to a kind of medical device included in the Register on or after 1 July 2024 (whether the inclusion day for the entry of that kind of medical device occurred before, on or after that day). #### 11.77 Reclassification of medical devices Applications and entries other than for transitional medical devices (1) The amendment of clause 5.5 of Schedule 2 to these Regulations made by Part 3 of Schedule 2 to the amending regulations applies in relation to the following: (a) an application for a kind of medical device to be included in the Register that is made on or after 1 July 2024; (b) a kind of medical device that is included in the Register as a result of such an application. Applications and entries for transitional medical devices (2) Subject to subregulations (3) and (4) of this regulation, the amendment of clause 5.5 of Schedule 2 to these Regulations made by Part 3 of Schedule 2 to the amending regulations applies in relation to a transitional medical device on and after 1 July 2026. (3) The amendment of clause 5.5 of Schedule 2 to these Regulations made by Part 3 of Schedule 2 to the amending regulations does not apply in relation to a transitional medical device before the day applicable under subregulation (4) of this regulation, if: (a) a person applies under the Act: (i) on or after the inclusion day for the entry of the transitional medical device; and (ii) on or after 1 July 2024; and (iii) before 1 July 2026; to have a kind (the new kind) of medical device included in the Register; and (b) the new kind of device would, but for the amendment, be the same kind of medical device as the transitional medical device. (4) For the purposes of subregulation (3), the day is the day after the day on which the application mentioned in paragraph (3)(a): (a) is withdrawn; or (b) lapses under section 41FK of the Act; or (c) is finally determined. (5) Subregulation 5.3(1) does not apply to an application for inclusion of the new kind of device in the Register. ### Division 11.21—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024 #### 11.78 Application provision—application audit assessment fees Table items 1.14A, 1.14AA and 1.14B of Part 1 of Schedule 5 to these Regulations, as amended or inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2024, apply in relation to an application that is made on or after 1 July 2024 and in relation to which an application audit assessment fee is payable because of subsection 41LA(3) of the Act. ### Division 11.22—Application provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 #### 11.79 Definitions In this Division: > amending regulations means the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024. #### 11.80 Application of amendments (1) The amendment made by item 3 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule. (2) The amendments made by items 4 and 5 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule. (3) The amendments made by items 6 and 7 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported on or after 1 October 2024. (4) The amendment made by item 8 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule. (5) The amendment made by item 12 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 October 2024. #### 11.81 Transitional vaping devices—exemption from Division 3 of Part 4‑11 of the Act (1) For the purposes of this regulation, medical devices that are exported from Australia are transitional vaping devices if: (a) the devices are therapeutic vaping devices, therapeutic vaping device accessories or therapeutic cannabis vaping goods; and (b) the devices were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and (c) as at that commencement, the importation or manufacture, or any supply, of the devices was done in accordance with any applicable laws of the Commonwealth or of a State or Territory. Exemption (2) For the purposes of paragraph 41HA(1)(b) of the Act, transitional vaping devices are exempt from the operation of Division 3 of Part 4‑11 of the Act. When exemption ceases (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence. ### Division 11.23—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024 #### 11.82 Definitions In this Division: > amending regulations means the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024. > commencement day means the day this Division commences. > conditions column means the column headed “Conditions” in the table in Part 2 of Schedule 4. > devices column means the column headed “Kinds of medical devices” in the table in Part 2 of Schedule 4. #### 11.83 Exempt therapeutic goods (1) Subject to this regulation, the amendments of these Regulations made by Part 1 of Schedule 1 to the amending regulations apply in relation to therapeutic goods that are: (a) imported or manufactured on or after the commencement day; or (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day. (2) The substitution of paragraph (c) of the conditions column in item 2.17 of the table in Part 2 of Schedule 4, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day. (3) Paragraph (e) of the conditions column in item 2.17 of the table in Part 2 of Schedule 4, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day. (4) The amendment to subparagraph (i)(ii) of the conditions column in item 2.17 of the table in Part 2 of Schedule 4, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day. (5) Subparagraph (i)(iii) of the conditions column in item 2.17 of the table in Part 2 of Schedule 4, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day. #### 11.84 Notices, statements and determinations (1) A notice: (a) given before the commencement day, under paragraph (a) (the old provision) of the conditions column in item 2.17 of the table in Part 2 of Schedule 4 as in force immediately before that day; and (b) not withdrawn or otherwise ceased to have effect (however described) before the commencement day; has effect on and after the commencement day as if it had been given under paragraph (b) (the new provision) of the devices column in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision). (2) A determination by the Secretary: (a) as referred to in paragraph (e) of the conditions column in item 2.17 of the table in Part 2 of Schedule 4 as in force immediately before that day; and (b) in force immediately before the commencement day; has effect on and after the commencement day as if it were a determination referred to in paragraph (d) of the devices column in that item. ### Division 11.24—Application provisions relating to the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 #### 11.85 Application provisions—Australian Unique Device Identification Database (1) The amendments of Schedule 1 made by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (except for the insertion of clause 13C.5 of Schedule 1 to this instrument) apply in relation to the following: (a) supplies of a UDI medical device on or after the general start day for the UDI medical device; (b) imports of a UDI medical device that occur after the first time, that is on or after the general start day for the UDI medical device, on which the UDI medical device is supplied for use in Australia; (c) exports of a UDI medical device on or after the general start day for the UDI medical device. (2) Clause 13C.5 of Schedule 1 to this instrument, as inserted by Part 1 of Schedule 1 to the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025, applies in relation to the following: (a) supplies of a UDI medical device on or after the direct marking start day for the UDI medical device; (b) imports of a UDI medical device that occur after the first time, that is on or after the direct marking start day for the UDI medical device, on which the UDI medical device is supplied for use in Australia; (c) exports of a UDI medical device on or after the direct marking start day for the UDI medical device. ### Division 11.25—Application provisions relating to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025 #### 11.86 Exempt therapeutic goods The amendment of Schedule 4 to these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2025 applies in relation to therapeutic goods on and after 1 July 2025 regardless of whether the goods were manufactured before, on or after that day.