The Australian Therapeutic Goods Administration (TGA) has announced that its Unique Device Identification (UDI) regulatory framework is now in effect following the approval of the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025. Additionally, the TGA has published new guidance and updated its website to reflect the commencement of the UDI regulatory framework, available via the TGA’s Unique Device Identification Hub.
UDI requirements
The Essential Principles have been amended to set out requirements related to UDI, including:
- Obtaining a UDI-Device Identifier (UDI-DI)
- Formatting the UDI-Production Identifier (UDI-PI)
- Including UDI in labeling, packaging, and Patient Implant Cards
- Direct marking of devices with the UDI-DI
- Submitting data in the Australian UDI database (AusUDID)
The TGA has provided further details on UDI labeling requirements on its website. The TGA’s new guidance, Complying with the Unique Device Identification Requirements for Medical Devices, outlines the requirements for obtaining and applying a UDI, as well as submitting and maintaining UDI data in the AusUDID.
All devices are subject to these UDI requirements, except for Class I and Class I (measuring) devices. Class 1 in vitro diagnostic devices (IVDs) are also exempt, unless they are considered instruments or software. Manufacturers may choose to assign and apply a UDI to exempt devices; if this is done, the TGA recommends meeting all UDI requirements to avoid confusion for end-users.
Australian Unique Device Identification (UDI) Framework Now in Effect | Emergo by UL
Australian Unique Device Identification (UDI) Framework Now in Effect
Australia’s medical device regulator, the Therapeutic Goods Administration, has announced that its Unique Device Identification regulatory framework is now in effect.
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