What this instrument does
The federal government registered the Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026 on 30 April 2026. The instrument amends the rules that list which foreign countries have approved medical device regulatory systems recognised in Australia. It was made under the Therapeutic Goods Act 1989.
Duration and status
The instrument was in force from 30 April 2026 to 18 August 2026. After 18 August 2026, it was repealed, meaning its changes were absorbed into the parent determination.
What changed
The source document does not specify which foreign countries were added, removed, or changed by this amendment.
Key actions
- Importers or suppliers of medical devices that rely on overseas regulatory approvals for Australian registration can check the current Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 on the Federal Register of Legislation at www.legislation.gov.au to confirm the relevant source country is still listed.
- The Department of Health, Disability and Ageing can be contacted for questions about whether this amendment affects a specific device or country of origin.
This is a plain-English summary for information only, not legal or compliance advice. Always check the official source or consult a qualified professional.