The Therapeutic Goods Administration (TGA) has introduced Medical Device Reforms to strengthen Australia's regulatory system for medical devices, ensure greater transparency of its systems and procedures, and be more patient-focused. The TGA has three strategies in place to administer these reforms.
The implementation of the Unique Device Identification (UDI) system forms part of TGA’s Strategy 2, which aims to improve patient safety through improved data analysis, data-sharing and post-market surveillance of medical devices. This will allow for rapid identification and follow-up in the event of an issue with a medical device.
This strategy also includes developing and managing the Australian Unique Device Identification Database (AusUDID), and the mandatory reporting of adverse events associated with medical devices. See more information about the adverse event reporting mandate.
What is a UDI?
The UDI system that is being implemented is based on a globally accepted coding standard and will be applied to specific medical device models, including implants, from around the world. The purpose of the system is to improve the way medical devices are identified, tracked and traced, so that action can be taken swiftly in the event of a safety concern.
What is AusUDID?
AusUDID will support the establishment of the UDI system in Australia. The database will enable timely access to complete, accurate and consistent information about medical devices in use in Australia.
Have a question? Email the CEC via cec-medicaldevicegovernance@health.nsw.gov.au.
