Unique identifiers for medical devices
The Australian Government is improving patient safety by introducing Unique Device Identification (UDI) for medical devices and in vitro diagnostic devices.
UDI gives each medical device a clear, standardised identifier, making it easier to find accurate information about the device. This helps healthcare organisations, clinicians and patients by improving safety and allowing faster identification of any device-related problems.
UDI will make it easier for healthcare services to identify, manage and monitor medical devices within their systems. It also helps record and track the exact device used on, or implanted into patients, and supports the quick removal of any devices found to be faulty or unsafe.
From July 2026, manufacturers and sponsors must start adding UDIs to the labels of high-risk medical devices, with other device types to follow in later years. They must also enter the UDI-Device Identifier and other required information into the Australian UDI Database (AusUDID), managed by the Therapeutic Goods Administration (TGA). Healthcare professionals and patients will be able to access this database.
We have worked with the TGA to ensure UDI is used consistently across the healthcare system by integrating it into processes that handle product and patient data. This work included collaboration with the Australian Government Department of Health, Disability and Ageing, and Queensland Health to pilot UDI in real-world settings.
For more information visit the UDI hub on the TGA website.