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Section 41HD Instruments

Instruments made under section 41HD of the Therapeutic Goods Act 1989 allows the Secretary to provide approval to sponsors to import and supply medical devices in a supply emergency situation under special exemptions and subject to conditions. 

About the instrument

The Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 supports the operation of section 41HD of the Therapeutic Goods Act 1989.

The Determination sets out:

  • the foreign countries where a medical device must already be registered or approved for general marketing before it can be considered under section 41HD; and
  • the types of medical devices that may be eligible for approval under that section.

This helps ensure that certain medical devices needed to mitigate critical supply disruptions can rely on approval or registration in comparable overseas jurisdictions, while maintaining appropriate safeguards for use in Australia.

Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 - Federal Register of Legislation

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