Insights & regulatory updates
Practical analysis for manufacturers and sponsors—focused on what changed, who is affected and the decisions that may need attention.
Latest analysis
Use these articles as a starting point, then verify the current TGA requirements for your device and circumstances.
A practical overview of Australia’s Unique Device Identification requirements from 1 July 2026 and the preparation priorities for Class IIb and Class III medical devices.
Read the analysisWhat the expanded section 41HD pathway means for sponsors seeking to import or supply medical devices during a critical shortage in Australia.
Read the analysisA practical guide to distinguishing patient-matched, custom-made and adaptable medical devices under Australia’s personalised-device framework.
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