Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
The Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 introduces the Unique Device Identification (UDI) system in Australia.
Official version of legislation
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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.
Guidance referring to this legislation
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GuidanceGuidance for healthcare facilities, including information about the requirements for data fields, timeframes for reporting and other considerations.
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia