TGA
From 1 July 2026, some medical devices supplied in Australia must meet Unique Device Identification (UDI) requirements. The introduction of UDI will begin with higher‑risk medical devices (Class IIb and Class III) followed by lower-risk medical device (Class IIa, Class Is and in vitro diagnostic devices) over later years. UDI can support consumers, health professionals, industry and other stakeholders to more easily access accurate and up‑to‑date information about medical devices.
UDI enables improved transparency and traceability across the medical device lifecycle, helping to strengthen safety and performance while supporting better information sharing and digital connectivity within the health system.
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