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.
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 immediately before the commencement of this instrument.
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 devicesQuality management systemsRequirements 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 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 auditing organisation means an organisation authorised to perform audits under the Medical Device Single Audit Program by the Regulatory Authority Council, in relation to that program, comprising the Australian Therapeutic Goods Administration, the United States Food and Drug Administration, the Brazilian Agência Nacional de Vigilância Sanitária, Health Canada, and 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.
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.
(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 Division 1 of 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.
(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.
(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.
(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.
Part 1—Class I medical devices
Division 1—Class I medical devices that are intended to be supplied in a non-sterile state and do not have a measuring function
Column 1 Item | Column 2 Regulatory authority | Column 3 Declaration of conformity in relation to the medical device | Column 4 Conformity assessment document relating to the medical device |
1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |
Division 2—Class I medical devices that are intended to be supplied in a sterile state or have a measuring function
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations: (a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function): (i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or (ii) Part 4 (production quality assurance procedures); (b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state): (i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; (ii) Part 3 (verification procedures); (iii) Part 4 (production quality assurance procedures); or (iv) Part 5 (product quality assurance procedures) | |
2 | a notified body within the meaning of Council Directive 93/42/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following: (i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or (ii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; (b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following: (i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; (ii) an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; (iii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or (iv) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC | |
3 | a notified body within the meaning of Council Directive 90/385/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state (whether or not it has a measuring function), either of the following: (i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or (ii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC; (b) for a medical device that has a measuring function (and that the manufacturer intends to be supplied in a non-sterile state), one of the following: (i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; (ii) an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or (iii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC | |
4 | a notified body within the meaning of the EU medical devices regulation | for a medical device that the manufacturer intends to be supplied in a sterile state and/or that has a measuring function, either of the following: (a) an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation; or (b) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation | |
5 | recognised auditing organisation | for a medical device that the manufacturer intends to be supplied in a sterile state and/or that has a measuring function
a MDSAP certificate | |
Part 2—Class IIa medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations: (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or (ii) Part 4 (production quality assurance procedures); (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state: (i) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; (ii) Part 3 (verification procedures); (iii)Part 4 (production quality assurance procedures); or (iv)Part 5 (product quality assurance procedures) | |
2 | a notified body within the meaning of Council Directive 93/42/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following: (i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or (ii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following: (i) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; (ii) an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; (iii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or (iv) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC | |
3 | a notified body within the meaning of Council Directive 90/385/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state, either of the following: (i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or (ii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following: (i) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; (ii) an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or (iii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC | |
4 | a notified body within the meaning of the EU medical devices regulation | an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation | |
5 | a notified body within the meaning of the EU medical devices regulation | (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following: (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or (ii) an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation | |
6 | Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals and Medical Devices Agency | either of the following: (a) a MDSAP certificate; or (b) a quality management system certificate for the purposes of the Japanese PMD Act | either of the following: (a) a pre-market certification issued under the Japanese PMD Act; or (b) a pre-market approval issued under the Japanese PMD Act |
7 | Health Canada | a MDSAP certificate | a Class II medical device licence issued under the Canadian medical devices regulations |
8 | United States
Food and Drug Administration | a MDSAP certificate | either of the following: (a) a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or (b) an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request) |
9 | Health Sciences Authority of Singapore | an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B medical device | |
Part 3—Class IIb medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part | |
2 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations: (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) Part 4 (production quality assurance procedures); (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state: (i) Part 3 (verification procedures); (ii) Part 4 (production quality assurance procedures); or (iii) Part 5 (product quality assurance procedures) | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures) |
3 | a notified body within the meaning of Council Directive 93/42/EEC | a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part | |
4 | a notified body within the meaning of Council Directive 93/42/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, one of the following: (i) an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; (ii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; or (iii) a product quality assurance certificate or other document issued under Annex VI of Council Directive 93/42/EEC | an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC |
5 | a notified body within the meaning of Council Directive 90/385/EEC | a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC | |
6 | a notified body within the meaning of the EU medical devices regulation | an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation | for a relevant implantable medical device—an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation |
7 | a notified body within the meaning of the EU medical devices regulation | (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following: (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or (ii) an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation | an EU type-examination certificate issued under Annex X of the EU medical devices regulation |
8 | Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency | either of the following: (a) a MDSAP certificate; or (b) a quality management system certificate for the purposes of the Japanese PMD Act | either of the following: (a) a pre-market certification issued under the Japanese PMD Act; or (b) a pre-market approval issued under the Japanese PMD Act |
9 | Health Canada | a MDSAP certificate | a Class III medical device licence issued under the Canadian medical devices regulations |
10 | United States
Food and Drug Administration | a MDSAP certificate | one of the following: (a) a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; (b) an order granting a request for classification under section 513 of the US FDC Act (a De Novo classification request); or (c) an order approving an application for premarket approval under section 515 of the US FDC Act |
11 | United States
Food and Drug Administration | an order approving an application for premarket approval under section 515 of the US FDC Act | |
12 | Health Sciences Authority of Singapore | an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C medical device | |
Part 4—Class III medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design) |
2 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations: (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) Part 4 (production quality assurance procedures); (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following: (i) Part 3 (verification procedures); or (ii) Part 4 (production quality assurance procedures) | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures) |
3 | a notified body within the meaning of Council Directive 93/42/EEC | a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Annex | an EC design-examination certificate issued under section 4 of Annex II of Council Directive 93/42/EEC |
4 | a notified body within the meaning of Council Directive 93/42/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following: (i) an EC verification certificate issued under Annex IV of Council Directive 93/42/EEC; or (ii) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC | an EC type-examination certificate issued under Annex III of Council Directive 93/42/EEC |
5 | a notified body within the meaning of Council Directive 90/385/EEC | a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC | an EC design examination certificate issued under section 4 of Annex 2 of Council Directive 90/385/EEC |
6 | a notified body within the meaning of Council Directive 90/385/EEC | (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following: (i) an EC verification certificate issued under Annex 4 of Council Directive 90/385/EEC; or (ii) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC | an EC type-examination certificate issued under Annex 3 of Council Directive 90/385/EEC |
7 | a notified body within the meaning of the EU medical devices regulation | an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation | an EU technical documentation assessment certificate issued under Chapter II of Annex IX of the EU medical devices regulation |
8 | a notified body within the meaning of the EU medical devices regulation | (a) for a medical device that the manufacturer intends to be supplied in a sterile state: (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state, either of the following: (i) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation; or (ii) an EU product verification certificate issued under Part B of Annex XI of the EU medical devices regulation | an EU type-examination certificate issued under Annex X of the EU medical devices regulation |
9 | Japan’s Ministry
of Health, Labour and Welfare or
the Japanese Pharmaceuticals
and Medical Devices Agency | either of the following: (a) a MDSAP certificate; or (b) a quality management system certificate for the purposes of the Japanese PMD Act | a pre-market approval issued under the Japanese PMD Act |
10 | Health Canada | a MDSAP certificate | a Class IV medical device licence issued under the Canadian medical devices regulations |
11 | United States
Food and Drug Administration | a MDSAP certificate | an order approving an application for premarket approval under section 515 of the US FDC Act |
12 | United States
Food and Drug Administration | an order approving an application for premarket approval under section 515 of the US FDC Act | |
13 | Health Sciences Authority of Singapore | an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D medical device | |
Schedule 2—IVD medical devices
Note: See section 6.
Part 1A—Class 1 IVD medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Declaration of conformity in relation to the medical device | Column 4 Conformity assessment document relating to the medical device |
1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |
Part 1—Class 2 IVD medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment | |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations: (a) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or (b) Part 4 (production quality assurance procedures) | | |
2 | a notified body within the meaning of Directive 98/79/EC | one of the following: (a) a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC; (b) a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC; or (c) for an application submitted before 26 May 2023a document certifying compliance with ISO 13485 | |
2A | a notified body within the meaning of Directive 98/79/EC | for an application submitted before 26 May 2027a document certifying compliance with ISO 13485 | an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022 |
3 | a notified body within the meaning of the EU IVD regulation | an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation | for an IVD medical device for self‑testing or an IVD medical device for point of care testing—an assessment of technical documentation referred to in section 5.1 of Annex IX of the EU IVD regulation | |
4 | Health Canada | a MDSAP certificate | a Class II medical device licence issued under the Canadian medical devices regulations | |
5 | United States
Food and Drug Administration | a MDSAP certificate | a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the
US FDC Act | |
6 | recognised auditing organisation | a MDSAP certificate | | |
7 | an IAF accredited conformity assessment body | for an application submitted before 26 May 2023a document certifying compliance with ISO 13485 | | |
8 | an IAF accredited conformity assessment body | for an application submitted before 26 May 2027a document certifying compliance with ISO 13485 | an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022 | |
9 | Health Sciences Authority of Singapore | an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class B IVD | | |
10 | Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency | either of the following: (a) a MDSAP certificate; or (b) a quality management system certificate for the purposes of the Japanese PMD Act | for an IVD medical device for self‑testing or an IVD medical device for point of care testing—one or more of the following: (a) a pre-market certification issued under the Japanese PMD Act; (b) a pre-market approval issued under the Japanese PMD Act |
| | | | | | |
Part 2—Class 3 IVD medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment | |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part) | | |
2 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 4 of Schedule 3 to the Regulations (production quality assurance procedures) | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures) | |
3 | a notified body within the meaning of Directive 98/79/EC | either of the following: (a) a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC; or (b) for an application submitted before 26 May 2023a document certifying compliance with ISO 13485 | |
3A | a notified body within the meaning of Directive 98/79/EC | for an application submitted before 26 May 2026a document certifying compliance with ISO 13485 | an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022 |
4 | a notified body within the meaning of Directive 98/79/EC | a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC | an EC type-examination certificate issued under Annex V of Directive 98/79/EC | |
5 | a notified body within the meaning of the EU IVD regulation | an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation | one of the following: (a) for an IVD medical device for self‑testing or an IVD medical device for point of care testing—an assessment of technical documentation set out in section 5.1 of Annex IX of the EU IVD regulation; or (b) for an IVD companion diagnostic—an assessment of technical documentation set out in section 5.2 of Annex IX of the EU IVD regulation; or (c) for other IVD medical devices—the assessment of technical documentation as set out in section 4 of Annex IX of the EU IVD regulation for at least one representative device in a generic device group | |
6 | a notified body within the meaning of the EU IVD regulation | an EU production quality assurance certificate issued under Annex XI of the EU IVD regulation, excluding section 5 of that Annex | an EU type-examination certificate issued under Annex X of the EU IVD regulation | |
7 | Health Canada | a MDSAP certificate | a Class III medical device licence issued under the Canadian medical devices regulations | |
8 | United States
Food and Drug Administration | a MDSAP certificate | either of the following: (a) a determination of substantial equivalence made with respect to a notification submitted under section 510(k) of the US FDC Act; or (b) an order approving an application for premarket approval under section 515 of the US FDC Act | |
9 | United States
Food and Drug Administration | an order approving an application for premarket approval under section 515 of the US FDC Act | an order approving an application for premarket approval under section 515 of the US FDC Act | |
10 | recognised auditing organisation | a MDSAP certificate | | |
11 | an IAF accredited conformity assessment body | for an application submitted before 26 May 2023a document certifying compliance with ISO 13485 | | |
12 | an IAF accredited conformity assessment body | for an application submitted before 26 May 2026a document certifying compliance with ISO 13485 | an EU declaration of conformity made by the manufacturer under Annex III of Directive 98/79/EC before 26 May 2022 | |
13 | Health Sciences Authority of Singapore | an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class C IVD | | |
14 | Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency | either of the following: (a) a MDSAP certificate; or (b) a quality management system certificate for the purposes of the Japanese PMD Act | for an IVD medical device for self‑testing or an IVD medical device for point of care testing—either of the following: (a) a pre-market certification issued under the Japanese PMD Act; or (b) a pre-market approval issued under the Japanese PMD Act |
| | | | | | |
Part 3—Class 4 IVD medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design) |
2 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 4 of Schedule 3 to the Regulations (production quality assurance procedures) | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 2 of Schedule 3 to the Regulations (type examination procedures) |
3 | a notified body within the meaning of Directive 98/79/EC | a full quality assurance system certificate or other document issued under section 3 of Annex IV of Directive 98/79/EC | an EC design-examination certificate issued under section 4 of Annex IV of Directive 98/79/EC |
4 | a notified body within the meaning of Directive 98/79/EC | a production quality assurance certificate or other document issued under Annex VII of Directive 98/79/EC | an EC type-examination certificate issued under Annex V of Directive 98/79/EC |
5 | a notified body within the meaning of the EU IVD regulation | an EU quality management system certificate issued under Chapter I of Annex IX of the EU IVD regulation | an EU design-examination certificate issued under Chapter II of Annex IX of the EU IVD regulation |
6 | a notified body within the meaning of the EU IVD regulation | an EU production quality assurance certificate issued under Annex XI of the EU IVD regulation | an EU type-examination certificate issued under Annex X of the EU IVD regulation |
7 | Japan’s Ministry of Health, Labour and Welfare or the Japanese Pharmaceuticals and Medical Devices Agency | either of the following: (a) a MDSAP certificate; or (b) a quality management system certificate for the purposes of the Japanese PMD Act | a pre-market approval issued under the Japanese PMD Act |
8 | United States Food and Drug Administration | an order approving an application for premarket approval under section 515 of the US FDC Act | an order approving an application for premarket approval under section 515 of the US FDC Act |
9 | Health Canada | a MDSAP certificate | a Class IV medical device licence issued under Canadian medical device regulations |
10 | Health Sciences Authority of Singapore | an extract from, or copy of, the entry in the Singapore Register of Health Products as a Class D IVD | |
Part 4—Class 4 in-house IVD medical devices
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document or other evidence relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in Part 1 of Schedule 3 to the Regulations (full quality assurance procedures), excluding clause 1.6 of that Part | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in clause 1.6 of Part 1 of Schedule 3 to the Regulations (examination of design) |
2 | Therapeutic Goods Administration | a manufacturing licence referred to in subparagraph 6B.3(2)(a)(ii) of Schedule 3 to the Regulations | |
3 | Therapeutic Goods Administration | a certificate of accreditation issued by NATA of the kind referred to in subparagraph 6B.3(2)(b)(i) of Schedule 3 to the Regulations | |
Schedule 2A—Medical devices intended for export only
Note: See section 6A.
Column 1 Item | Column 2 Regulatory authority | Column 3 Declaration of conformity in relation to the medical device | Column 4 Conformity assessment document relating to the medical device |
1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 6.6 of Schedule 3 to the Regulations | |
Schedule 3—Medical devices used for a special purpose that are a system or procedure pack
Note: See section 7.
Part 1—All medical devices used for a special purpose that are a system or procedure pack
Division 1—System or procedure packs that are Class I medical devices intended to be supplied in a non-sterile state and that do not have a measuring function, Class 1 IVD medical devices, or intended for export only
Column 1 Item | Column 2 Regulatory authority | Column 3 Declaration of conformity in relation to the system or procedures pack | Column 4 Conformity assessment document in relation to each medical device |
1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations | |
Division 2—System or procedure packs that are not Class I medical devices intended to be supplied in a non-sterile state and that do not have a measuring function, not Class 1 IVD medical devices, or not intended for export only
Column 1 Item | Column 2 Regulatory authority | Column 3 Declaration of conformity in relation to the system or procedure pack | Column 4 Conformity assessment document in relation to each medical device |
1 | Therapeutic Goods Administration | a declaration of conformity made by the manufacturer under clause 7.5 of Schedule 3 to the Regulations | a conformity assessment document in relation to each medical device contained in the system or procedure pack |
Part 2—System or procedure packs that are intended to be supplied in a sterile state and that are not Class 1 IVD medical devices, or not intended for export only
Column 1 Item | Column 2 Regulatory authority | Column 3 Conformity assessment document relating to manufacturer’s quality management system | Column 4 Conformity assessment document relating to product assessment |
1 | Therapeutic Goods Administration | a conformity assessment certificate issued under the Act that covers the conformity assessment procedures set out in one of the following Parts of Schedule 3 to the Regulations: (a) Part 1 (full quality assurance procedures), excluding clause 1.6 of that Part; or (b) Part 4 (production quality assurance procedures) | |
2 | a notified body within the meaning of Council Directive 93/42/EEC | either of the following: (a) a full quality assurance system certificate or other document issued under Annex II of Council Directive 93/42/EEC, excluding section 4 of that Part; or (b) a production quality assurance certificate or other document issued under Annex V of Council Directive 93/42/EEC; | |
3 | a notified body within the meaning of Council Directive 90/385/EEC | either of the following: (a) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 of Council Directive 90/385/EEC; or (b) an assurance of production quality certificate or other document issued under Annex 5 of Council Directive 90/385/EEC; | |
4 | a notified body within the meaning of the EU medical devices regulation | either of the following: (a) an EU quality management system certificate issued under Chapter I of Annex IX of the EU medical devices regulation; or (b) a production quality assurance certificate issued under Part A of Annex XI of the EU medical devices regulation | |
5 | recognised auditing organisation | a MDSAP certificate | |
