Therapeutic Goods (Overseas Regulators) Amendment Determination 2025

I, Tracey Duffy, as delegate of the Secretary of the Department of Health, Disability and Ageing, make the following determination.

Dated 29 October 2025

Tracey Duffy

Contents

1  Name

2  Commencement

3  Authority

4  Schedules

Schedule 1—Amendments

Therapeutic Goods (Overseas Regulators) Determination 2018

1  Name

  This instrument is the Therapeutic Goods (Overseas Regulators) Amendment Determination 2025.

2  Commencement

 (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.

Note: This table relates only to the provisions of this instrument as originally made.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 41BIB(2) 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  Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 (Overseas Regulators) Determination 2018

1  Section 4 (note)

Repeal the note, substitute:

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) overseas regulator;

(b) medical device.

2  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.

3  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).

4  Section 5

Repeal the section, substitute:

5  Overseas regulators

  Each of the following is determined to be an overseas regulator for the purposes of subsection 41BIB(1) of the Act:

 (a) an IAF accredited conformity assessment body;

 (b) a notified body;

 (c) a recognised or authorised auditing organisation;

 (d) Health Canada;

 (e) Health Sciences Authority of Singapore;

 (f) Japan’s Ministry of Health, Labour and Welfare;

 (g) the Japanese Pharmaceuticals and Medical Devices Agency;

 (h) the United States Food and Drug Administration;

 (i) a UK approved body.