Commonwealth legislation

Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

In ForceCTH

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

3/10 complexity

This Determination designates specific foreign jurisdictions and a single medical device class (cannulas for cardiac surgery/cardiopulmonary bypass) as eligible for approvals under section 41HD of the Therapeutic Goods Act. It affects manufacturers, sponsors and importers (who may need foreign regulatory links or extra evidence) and ties Australian eligibility to regulatory status in those listed countries.

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Current sections

Direct links to the current provisions in Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026.

Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

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Commonwealth Coat of Arms of Australia

Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

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

Dated 6 March 2026

Marcelle Noja

Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health, Disability and Ageing

Contents

1 Name

2 Commencement

3 Authority

4 Definitions

5 Medical devices—foreign countries and specified devices

Schedule 1—Foreign countries

Schedule 2—Specified medical devices

1 Name

This instrument is the Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026.

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.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument The day after this instrument is registered.

Note: This table relates only to the provisions of this instrument as originally made.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 subsections 41HD(5) and 41HD(6) of the Therapeutic Goods Act 1989.

4 Definitions

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

(a) medical device.

In this instrument:

Act means the Therapeutic Goods Act 1989.

5 Medical devices—foreign countries and specified devices

(1) The countries specified in Schedule 1 are foreign countries for the purposes of subparagraph 41HD(1)(d)(i) of the Act.

(2) The medical devices specified in Schedule 2 are medical devices that can be the subject of an approval under section 41HD of the Act.

Schedule 1—Foreign countries

Note: See subsection 5(1).

Foreign countries
Column 1 Column 2
Item Countries
1 Brazil
2 Canada
3 China (the People’s Republic of)
4 Japan
5 Member states of the European Union
6 Singapore
7 United Kingdom of Great Britain and Northern Ireland
8 United States of America

Schedule 2—Specified medical devices

Note: See subsection 5(2).

Specified medical devices
Column 1 Column 2
Item Medical devices
1 cannulas for use in cardiac surgery or cardiopulmonary bypass procedures

Source text

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

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Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

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

Dated 6 March 2026

Marcelle Noja

Assistant Secretary Medical Devices and Product Quality Division Health Products Regulation Group Department of Health, Disability and Ageing

Contents

1 Name

2 Commencement

3 Authority

4 Definitions

5 Medical devices—foreign countries and specified devices

Schedule 1—Foreign countries

Schedule 2—Specified medical devices

1 Name

This instrument is the Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026.

2 Commencement

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument The day after this instrument is registered.

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.

3 Authority

This instrument is made under subsections 41HD(5) and 41HD(6) of the Therapeutic Goods Act 1989.

4 Definitions

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

(a) medical device.

In this instrument:

Act means the Therapeutic Goods Act 1989.

5 Medical devices—foreign countries and specified devices