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The Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 introduces the Unique Device Identification (UDI) system in Australia.
This system aims to enhance the traceability, safety, and post-marketing management of medical devices.
The regulations establish the Australian Unique Device Identification Database and set out the requirements for UDI, including the assignment of a UDI code for each medical device.
The system is voluntary at the start, with mandatory labelling requirements for most medical devices set to begin on July 1, 2026.