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Section 41HD Instruments

Learn how Section 41HD instruments allow the TGA to approve the import and supply of certain medical devices during supply emergencies, using overseas approvals and safeguards.

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) Amendment Determination 2026 - Federal Register of Legislation

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