Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018

1 Name

This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018.

3 Authority

This instrument is made under subsections 41FDB(7) and 41FDB(8) of the Therapeutic Goods Act 1989.

4 Definitions

Note: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:

(a) conformity assessment certificate;
(b) conformity assessment document;
(c) conformity assessment procedures;
(d) included in the Register;
(e) kind, in relation to a medical device;
(f) medical device;
(g) system or procedure pack.

In this instrument:

Act means the Therapeutic Goods Act 1989.

application means an application to the Secretary for a kind of medical device to be included in the Register under section 41FC of the Act.

applied Directive 90/385 has the meaning given to “Directive 90/385” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 90/385 is to be construed in accordance with regulation 2(1A) of the UK Regulations. applied Directive 93/42 has the meaning given to “Directive 93/42” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 93/42 is to be construed in accordance with regulation 2(1A) of the UK Regulations. applied Directive 98/79 has the meaning given to “Directive 98/79” in regulation 2(1) of the UK Regulations, and a reference to an Annex in applied Directive 98/79 is to be construed in accordance with regulation 2(1A) of the UK Regulations.

Canadian medical devices regulations means the Medical Devices Regulations (SOR/98-282) made under the Food and Drugs Act of Canada, as in force immediately before the commencement of this instrument.

certified translation means a translation that contains a statement, dated and signed by a person, to the effect that the translation is a true and complete translation of the accompanying document.

Class 1 IVD medical device has the same meaning as in the Regulations. Class 2 IVD medical device has the same meaning as in the Regulations. Class 3 IVD medical device has the same meaning as in the Regulations. Class 4 IVD medical device has the same meaning as in the Regulations. Class 4 in-house IVD medical device has the same meaning as in the Regulations.

Class I medical device has the same meaning as in the Regulations.

Class IIa medical device has the same meaning as in the Regulations. Class IIb medical device has the same meaning as in the Regulations. Class III medical device has the same meaning as in the Regulations. clinical evaluation report means a report prepared by a manufacturer detailing the assessment and analysis of clinical data to verify the safety and performance of a medical device when used as intended by the manufacturer. Council Directive 90/385/EEC means Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) of the Council of the European Communities, as in force immediately before the commencement of this instrument. Council Directive 93/42/EEC means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices of the Council of the European Communities, as in force immediately before the commencement of this instrument. Directive 98/79/EC means Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, as in force immediately before the commencement of this instrument. EU IVD regulation means 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 on 1 December 2024. EU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force immediately before the commencement of this instrument.

generic device group has the same meaning as in the EU IVD regulation.

IAF accredited conformity assessment body means a body that is accredited to undertake certification for compliance with ISO 13485 by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA. implantable medical device has the same meaning as in the Regulations. in-house IVD medical device has the same meaning as in the Regulations.

instructions for use has the same meaning as in the Regulations.

ISO 13485 means International Standard ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, issued by the International Organization for Standardization in March 2016, as in force or existing immediately before the commencement of this instrument.

Note: ISO 13485 is published at: https://www.iso.org.

IVD companion diagnostic has the same meaning as in the Regulations.

IVD medical device, or in vitro diagnostic medical device, has the same meaning as in the Regulations.

IVD medical device for self-testing has the same meaning as in the Regulations.

Japanese PMD Act means The Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices of Japan, as in force immediately before the commencement of this instrument. manufacturing licence has the same meaning as in the Regulations. MDSAP certificate means a certification document issued by a recognised or authorised auditing organisation, following the completion of an audit of a manufacturer’s quality management system. measuring function has the same meaning as in the Regulations. medical device used for a special purpose has the same meaning as in the Regulations. NATA has the same meaning as in the Regulations. notified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.

point of care testing has the same meaning as in the Regulations.

quality management system certificate means a certificate that is issued following an assessment of a manufacturer’s quality management system, but does not include a MDSAP certificate. recognised or authorised auditing organisation means an organisation that is recognised or authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council in relation to that program, comprising Australia’s Therapeutic Goods Administration, the United States Food and Drug Administration, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency. Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002. relevant implantable medical device means an implantable medical device other than a medical device: (a) mentioned in paragraphs 13A.1(1)(b) or (ba) of Schedule 1 to the Regulations; or (b) to which subclause 13A.1(2) of Schedule 1 to the Regulations applies.

Note: Medical devices mentioned in paragraph 13A.1(1)(b) of Schedule 1 to the Regulations include, for example, sutures, staples, dental fillings and dental braces. The medical devices mentioned in paragraph 13A.1(1)(ba) of Schedule 1 to the Regulations are medical devices that are intended by the manufacturer to be for export only.

Singapore Health Products Act means the Health Products Act 2007 of Singapore as in force on 1 July 2022. Singapore Register of Health Products means the Register of Health Products kept and maintained by the Health Sciences Authority of Singapore under section 34 of the Singapore Health Products Act. Therapeutic Goods Administration means that part of the Department known as the Therapeutic Goods Administration. UK approved body has the meaning given to “approved body” in regulation A45 of the UK Regulations. UK Regulations means the Medical Devices Regulations 2002 (SI 2002/618), as in force in England, Wales and Scotland on 1 December 2025.

Note: The UK Regulations could in 2025 be viewed on the UK legislation website (www.legislation.gov.uk).

US FDC Act means the Federal Food, Drug, and Cosmetic Act of the United States, as in force immediately before the commencement of this instrument.

5 Kind of information—medical devices other than IVD medical devices

Class I medical devices (1A) An application for a Class I medical device that the manufacturer intends to be supplied in a non-sterile state and that does not have a measuring function must be accompanied by the following kind of information: (a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 1, which is recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (1) An application for a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 2 of Part 1 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (2) To avoid doubt: (a) for the purpose of subsection (1), an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any); (b) a document which accompanies an application in accordance with subsection (1) or (1A) must relate to the kind of device to which the application relates. Class IIa medical devices (3) An application for a Class IIa medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (4) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any); (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates. Class IIb medical devices (5) An application for a Class IIb medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (6) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any); (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates. Class III medical devices (7) An application for a Class III medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 1, which is issued or recognised by the regulatory authority in column 2 of that item; (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; (c) if the application is not accompanied by a conformity assessment certificate issued by the TGA—a clinical evaluation report and the instructions for use. (8) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any); (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.

Application of this section

(11) This section does not apply to any of the following:

(a) a medical device used for a special purpose;

(b) a medical device that is intended by the manufacturer to be for export only.

6 Kind of information—IVD medical devices

Class 1 IVD medical devices (1A) An application for a Class 1 IVD medical device must be accompanied by the following kind of information: (a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1A of Schedule 2, which is recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (1B) To avoid doubt, a document which accompanies the application in accordance with subsection (1A) must relate to the kind of device to which the application relates. Class 2 IVD medical devices (1) An application for a Class 2 IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 1 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and (c) if the application is accompanied by the information specified in item 2 or 2B in the table in Part 1 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation. (2) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (1)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (1)(b) (if any); (b) a document which accompanies the application in accordance with subsection (1) must relate to the kind of device to which the application relates. Class 3 IVD medical devices (3) An application for a Class 3 IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and (c) if the application is accompanied by the information specified in item 3, 3B or 4 in the table in Part 2 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation. (4) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (3)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (3)(b) (if any); (b) a document which accompanies the application in accordance with subsection (3) must relate to the kind of device to which the application relates. Class 4 IVD medical devices (5) An application for a Class 4 IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 3 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item; and (c) if the application is accompanied by the information specified in item 3 or 4 in the table in Part 3 of Schedule 2—evidence to demonstrate compliance with Article 110(3c) of the EU IVD regulation. (6) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (5)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (5)(b) (if any); (b) a document which accompanies the application in accordance with subsection (5) must relate to the kind of device to which the application relates. Class 4 in-house IVD medical devices (7) An application for a Class 4 in-house IVD medical device must be accompanied by the following kind of information: (a) a conformity assessment document or other evidence that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 4 of Schedule 2, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (8) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (7)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (7)(b) (if any); (b) a document which accompanies the application in accordance with subsection (7) must relate to the kind of device to which the application relates.

Application of this section

(9) This section does not apply to any of the following:

(a) a medical device used for a special purpose;

(b) a medical device that is intended by the manufacturer to be for export only.

6A Kind of information—medical devices intended for export only

(1) An application for a medical device that is intended by the manufacturer to be for export only, including an IVD medical device, must be accompanied by the following kind of information:

(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Schedule 2A, which is recognised by the regulatory authority in column 2 of that item; and

(b) a conformity assessment document in relation to the medical device specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

(2) To avoid doubt, a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.

Application of this section

(3) This section does not apply to a medical device used for a special purpose.

7 Kind of information—medical devices used for a special purpose that are a system or procedure pack

(1A) An application for a medical device used for a special purpose that is a system or procedure pack and:

(a) classified under the Regulations as a Class I medical device that:

(i) does not have a measuring function; and

(ii) the manufacturer intends to be supplied in a non-sterile state; or

(b) classified under the Regulations as a Class 1 IVD medical device; or

(c) intended by the manufacturer to be for export only;

must be accompanied by the following kind of information:

(d) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 1 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and

(e) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

(1) An application for a medical device used for a special purpose that is a system or procedure pack, other than a medical device that is mentioned in subsection (1A), must be accompanied by the following kind of information:

(a) a declaration of conformity that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Division 2 of Part 1 of Schedule 3, which is recognised by the regulatory authority in column 2 of that item; and

(b) a conformity assessment document in relation to each medical device contained in the system or procedure pack specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item.

Additional information required where the manufacturer intends the medical device used for a special purpose to be supplied in a sterile state (2) An application for a medical device to which subsection (1) applies, and which the manufacturer intends to be supplied in a sterile state, must also be accompanied by the following kind of information: (a) a conformity assessment document that relates to the manufacturer’s quality management system specified in column 3 of an item in the table in Part 2 of Schedule 3, which is issued or recognised by the regulatory authority in column 2 of that item; and (b) a conformity assessment document that relates to product assessment specified for that item in column 4 (if any), which is issued or recognised by the regulatory authority in column 2 of that item. (3) To avoid doubt: (a) an application may be accompanied by more than one document referred to in paragraph (2)(a), and its corresponding certificate or other document of product assessment referred to in paragraph (2)(b) (if any); (b) a document which accompanies the application in accordance with this section must relate to the kind of device to which the application relates.

8 Alternative kinds of information

Medical devices other than IVD medical devices (1) An application for a medical device other than an IVD medical device may be accompanied by the kind of information determined under section 5 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section. IVD medical devices (2) An application for an IVD medical device may be accompanied by the kind of information determined under section 6 that relates to an application for a kind of medical device that is classified at a higher level than the medical device concerned, rather than the kind of information determined for that class of medical device under that section.

Note: The kind of information determined under sections 5 and 6 relate to the minimum conformity assessment procedures that the manufacturer must apply to a kind of device of that classification.

9 Classes of medical device for which accompanying information is not determined

To avoid doubt, no kind of information is determined for the purposes of subsection 41FDB(7) for an application in relation to a medical device in one of the following classifications:

(a) an in-house IVD medical device other than a Class 4 in-house IVD medical device;

(b) a medical device used for a special purpose that is not a system or procedure pack.

Note: In effect, this means that no information must accompany applications in relation to these classifications.

10 Form of information—all medical devices

All information that accompanies an application in accordance with section 5, 6 or 7 must be: (a) legible; and (b) either of the following: (i) in English; or (ii) if it is not in English—be accompanied by a certified translation into English.

Schedule 1—Medical devices other than IVD medical devices

Note: See section 5.