TGA UDI Requirements for Medical Devices Commence in Australia
The Therapeutic Goods Administration (TGA) has announced that new Unique Device Identification (UDI)requirements for certain medical devices supplied in Australia commenced on 1 July 2026.
According to the TGA, the introduction of UDI will begin with higher-risk medical devices, specifically Class IIb and Class III devices, followed by lower-risk medical devices, including Class IIa, Class Is and in vitro diagnostic devices, over later years.
Purpose of UDI
The TGA states that UDI can support consumers, health professionals, industry and other stakeholders by making it easier to access accurate and up-to-date information about medical devices.
UDI also 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.
Progressive Implementation
UDI requirements will be progressively rolled out to other medical device classifications over the coming years.
The TGA has published guidance on:
complying with UDI requirements for medical devices;
implementation timeframes and specific requirements for manufacturers and sponsors;
how compliance with UDI requirements will be assessed as part of pre-market approval activities.
Australian UDI Database
Information on medical devices that have a UDI will be available through the Australian UDI Database (AusUDID).
The TGA has also published practical guidance for consumers explaining what UDI is and how to search the database.
According to the TGA, 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.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers supplying products in Australia, the commencement of UDI requirements introduces important regulatory and operational considerations.
Manufacturers and sponsors should pay particular attention to:
whether their devices fall within the first implementation phase;
UDI requirements for Class IIb and Class III devices;
future rollout timelines for Class IIa, Class Is and IVDs;
preparation of UDI data for AusUDID;
alignment of labelling, device identification and traceability processes;
how UDI compliance may be assessed during pre-market approval activities;
internal data governance and lifecycle management of device information.
For manufacturers, the rollout highlights the need to prepare early for UDI implementation, particularly where product portfolios include higher-risk devices or devices that will fall within later implementation phases.
