Part 1
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Commonwealth legislation
This law sets a risk-based regulatory system for medical devices in Australia: classifying devices by risk, requiring conformity assessments and unique-device identification, accrediting conformity-assessment bodies, and allowing limited exemptions. It affects manufacturers, Australian sponsors, healthcare providers and patients (especially recipients of implants). It matters because it raises pre-market scrutiny for higher-risk devices, improves post-market tracking and reporting, and aims to keep unsafe or ineffective devices out of use.
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Direct links to the current provisions in Therapeutic Goods (Medical Devices) Regulations 2002.
These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.
(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) 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) 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.
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) 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).
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.
For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.
(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) 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) 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.
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) 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).
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.
For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1.
These Regulations are the Therapeutic Goods (Medical Devices) Regulations 2002.
(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) 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) 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.
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) 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).
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.
For section 41CA of the Act, the essential principles for medical devices are set out in Schedule 1.
(1) For section 41DB of the Act, the following table specifies the medical device classifications.
<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"><p class="TableHeading"><span>Medical device classifications</span></p></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"><p class="TableHeading"><span></span></p></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"><p class="TableHeading"><span></span></p></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"><p class="TableHeading"><span></span></p></td></tr><tr><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span></span></p></td><td style="width:116.9pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 4</span></p></td><td style="width:46pt; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 5</span></p></td></tr><tr><td style="width:46pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:116.9pt; border-bottom:1.5pt solid #000000; padding-right:5.35pt;
This is an opening excerpt, not the complete document.