The Therapeutic Goods Administration (TGA) is introducing a unique device identification (UDI) system for medical devices supplied in Australia.
We are coordinating the NSW Health response to support implementation of the UDI system across health services. This work aims to strengthen medical device traceability and support patient safety.
Why it is important
Medical devices are used throughout NSW Health services. Being able to accurately identify a device can help support patient safety and improve the management of safety concerns.
The UDI system will:
- improve identification of medical devices
- support device tracking and traceability
- help identify affected devices more quickly when issues arise
- support follow-up activities after safety alerts, recalls or adverse events.
What is UDI?
A unique device identifier (UDI) is a globally recognised code assigned to a specific medical device model, including implantable devices.
The code provides consistent information about a device and helps ensure it can be accurately identified throughout its lifecycle.
Australian Unique Device Identification Database (AusUDID)
The Australian Unique Device Identification Database (AusUDID) supports the UDI system in Australia.
AusUDID will provide access to consistent and reliable information about medical devices supplied in Australia. The database will help healthcare organisations and regulators access device information when it is needed.
What this means for NSW Health services
By improving the traceability of medical devices throughout their lifecycle, UDI will enhance the ability to identify and respond to device recalls, safety alerts, and adverse events more quickly and effectively. This strengthens patient safety, reduces clinical risk, and supports timely communication and follow-up when device-related issues arise.
Over time, UDI will also help build a more robust foundation for quality improvement, regulatory compliance, and data-driven healthcare decision-making across NSW Health.
More about TGA Strategy 2: Strengthen the monitoring and follow up of devices already in use