New UDI requirements for medical devices commence 1 July 2026

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.

UDI requirements will be progressively rolled out to other medical device classifications over the coming years. Detailed guidance on these requirements is available at: Complying with the Unique Device Identification requirements for medical devices.

Implementation timeframes and the specific requirements for manufacturers and sponsors are available at: Complying with the Unique Device Identification timeframes for medical devices.

The TGA has also published information outlining how compliance with UDI requirements will be assessed as part of pre‑market approval activities at: UDI and other TGA processes or activities.

Information on medical devices that have a UDI will be available through the Australian UDI Database (AusUDID): Australian UDI Database.

Consumers can also access practical guidance on what UDI is and how to search the database at: Unique Device Identification for consumers.

The launch of UDI marks a significant milestone in Australia’s medical device regulatory framework, reinforcing patient safety through improved visibility, traceability and trust in medical devices.