UDI for healthcare

Note

To help healthcare organisations adopt UDI into their processes, see:

UDI for Australian healthcare: Executive summary

Overview of Unique Device Identification for Australian Healthcare

We have implemented the Unique Device Identification (UDI) system for medical devices in Australia.

Under the UDI framework, manufacturers supplying medical devices in Australia are required to:

• assign a Unique Device Identifier (UDI) to their devices
• include the UDI on device labels and packaging
• submit UDI records to the TGA via the Australian UDI Database (AusUDID).

UDIs can be incorporated into hospital systems and patient records, such as My Health Record, to accurately identify the specific medical device model used or implanted.

Healthcare and patients can access device information through the AusUDID, a publicly available database.

Development of the UDI system involved:

• amending the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Device) Regulations 2002: Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
• establishing the AusUDID, which the TGA maintains
• consulting with medical device sponsors and manufacturers
• consulting with the healthcare community about UDI and its use across the healthcare supply chain
• engaging with the Australian Commission on Safety and Quality in Healthcare (ACSQHC), and
• working with state and territory healthcare pilot sites to support and inform UDI adoption in healthcare organisations.

The main purpose of UDI is to improve patient safety. When adopted into supply chain, clinical and other health systems, UDI enables faster and more accurate identification of devices used on or implanted into patients in the event of an adverse event, market action or recall. It also supports identification and removal of those devices from stock, storage and distribution, helping prevent further use of impacted products.

By providing a means to accurately identify devices, UDI supports improved device performance assessment by regulatory bodies, clinical quality registries and device manufacturers.

With the UDI system now in place, we will continue to work with global regulators to harmonise UDI requirements, share learnings and promote UDI adoption in healthcare organisations.

For further information, see: Unique Device Identification (UDI) hub.