Unique Device Identification (UDI) information session for clinical quality registries

This information session introduced Unique Device Identification (UDI) for clinical quality registries. Australia’s UDI framework supports improved identification of medical devices and in vitro diagnostic (IVD) devices and will be a legal mandatory requirement for high-risk and implantable devices from 1 July 2026.

From this date, manufacturers, sponsors and suppliers must place UDIs on labels and packaging and submit UDI data to the Australian UDI Database (AusUDID). The UDI aims to support faster and more accurate identification of medical devices for patients, healthcare professionals, hospitals and clinical quality registries. The UDI will be used by suppliers and the TGA in reporting and responding to issues or problems with medical devices, including recall actions. However, the success of the UDI also relies on information being captured and recorded in clinical processes and systems, including medical records, discharge summaries and registries.

The session was designed for clinical quality registries and stakeholders interested in how UDI can be used by registries.

It covered:

• an overview of the UDI framework
• implementation processes
• how to access the AusUDID
• a dedicated Q&A session.

Speakers

• Gary Pascoe, UDI Project Lead, Device Reform Taskforce Section, TGA
• Tracey Duffy, First Assistant Secretary, Medical Devices and Product Quality Division, TGA

Slides

For more information on UDI, visit: Unique Device Identification (UDI) hub.