This instrument is the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025.

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	1 December 2025.	1 December 2025

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

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

4 Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

1 Section 4

Insert:

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.

2 Section 4 (definition of MDSAP certificate)

After “recognised”, insert “or authorised”.

3 Section 4 (definition of recognised auditing organisation)

Repeal the definition, substitute:

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.

4 Section 4

Insert:

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).

5 Division 2 of Part 1 of Schedule 1 (cell at table item 5, column 2)

Repeal the cell, substitute:

recognised or authorised auditing organisation

6 Division 2 of Part 1 of Schedule 1 (at the end of the table)

Add:

a UK approved body

(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 in applied Directive 90/385;

(ii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385;

(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 in applied Directive 90/385;

(ii) a verification certificate of conformity issued under Annex 4 in applied Directive 90/385;

(iii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385

a UK approved body

(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 in applied Directive 93/42, excluding section 4 of that Annex;

(ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;

(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 in applied Directive 93/42, excluding section 4 of that Annex;

(ii) a verification certificate of conformity issued under Annex IV in applied Directive 93/42;

(iii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;

(iv) a product quality assurance certificate or other document issued under Annex VI in applied Directive 93/42

7 Part 2 of Schedule 1 (after table item 8)

Insert:

United States Food and Drug Administration

a MDSAP certificate

for medical devices that are exempted, by the United States Food and Drug Administration, from section 510(k) requirements—a statement that includes the device name or description, regulation number and submission type under United States Food and Drug Administration requirements

8 Part 2 of Schedule 1 (at the end of the table)

Add:

a UK approved body

(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 in applied Directive 93/42, excluding section 4 of that Annex;

(ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;

(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 in applied Directive 93/42, excluding section 4 of that Annex;

(ii) a verification certificate of conformity issued under Annex IV in applied Directive 93/42;

(iii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;

(iv) a product quality assurance certificate or other document issued under Annex VI in applied Directive 93/42

a UK approved body

(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 in applied Directive 90/385;

(ii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385;

(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 in applied Directive 90/385;

(ii) a verification certificate of conformity issued under Annex 4 in applied Directive 90/385;

(iii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385

9 Part 3 of Schedule 1 (at the end of the table)

Add:

a UK approved body

a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex

a UK approved body

(a) for a medical device that the manufacturer intends to be supplied in a sterile state—a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;

(b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—one of the following:

(i) a verification certificate of conformity issued under Annex IV in applied Directive 93/42;

(ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42;

(iii) a product quality assurance certificate or other document issued under Annex VI in applied Directive 93/42

a UK approved body

a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385

10 Part 4 of Schedule 1 (at the end of the table)

Add:

14	a UK approved body	a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex	a design examination certificate issued under section 4 of Annex II in applied Directive 93/42
15	a UK approved body	(a) for a medical device that the manufacturer intends to be supplied in a sterile state—a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—either of the following: (i) a verification certificate of conformity issued under Annex IV in applied Directive 93/42; (ii) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42	a type‑examination certificate issued under Annex III in applied Directive 93/42
16	a UK approved body	a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385	a design examination certificate issued under section 4 of Annex 2 in applied Directive 90/385
17	a UK approved body	for a medical device that the manufacturer intends to be supplied in a sterile state—an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385; (b) for a medical device that the manufacturer intends to be supplied in a non-sterile state—either of the following: (i) a verification certificate of conformity issued under Annex 4 in applied Directive 90/385; (ii) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385	a type‑examination certificate issued under Annex 3 in applied Directive 90/385

11 Part 1 of Schedule 2 (cell at table item 6, column 2)

Repeal the cell, substitute:

recognised or authorised auditing organisation

12 Part 1 of Schedule 2 (at the end of the table)

Add:

a UK approved body

either of the following:

(a) a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive 98/79;

(b) a production quality assurance certificate or other document issued under Annex VII in applied Directive 98/79

13 Part 2 of Schedule 2 (cell at table item 10, column 2)

Repeal the cell, substitute:

recognised or authorised auditing organisation

14 Part 2 of Schedule 2 (at the end of the table)

Add:

15	a UK approved body	a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive 98/79
16	a UK approved body	a production quality assurance certificate or other document issued under Annex VII in applied Directive 98/79	a type‑examination certificate issued under Annex V in applied Directive 98/79

15 Part 3 of Schedule 2 (at the end of the table)

Add:

11	a UK approved body	a full quality assurance system certificate or other document issued under section 3 of Annex IV in applied Directive 98/79	a design‑examination certificate issued under Annex IV in applied Directive 98/79
12	a UK approved body	a production quality assurance certificate or other document issued under Annex VII in applied Directive 98/79	a type‑examination certificate issued under Annex V in applied Directive 98/79

16 Part 2 of Schedule 3 (cell at table item 5, column 2)

Repeal the cell, substitute:

recognised or authorised auditing organisation

17 Part 2 of Schedule 3 (at the end of the table)

Add:

a UK approved body

either of the following:

(a) a full quality assurance system certificate or other document issued under Annex II in applied Directive 93/42, excluding section 4 of that Annex;

(b) a production quality assurance certificate or other document issued under Annex V in applied Directive 93/42

a UK approved body

either of the following:

(a) a complete quality assurance system certificate or other document issued under section 3 of Annex 2 in applied Directive 90/385;

(b) an assurance of production quality certificate or other document issued under Annex 5 in applied Directive 90/385