Do you meet requirements for UDI?

Increased regulations mandating Unique Device Identification have emerged requiring uses of global standards.

Following recommendations from the International Medical Device Regulators Forum (IMDRF) an increasing number of regulations mandating Unique Device Identification (UDI) have emerged requiring use of global standards to identify medical devices.

The Australian Government has strengthened patient safety by introducing Unique Device Identification (UDI) regulations for medical devices. UDI supports the identification of medical devices and is designed to improve the effectiveness of the regulatory framework, including the management of post-market safety-related activities, such as recalls.

Learn more about how to use GS1 standards for uniquely identifying products here and access the reference tools provided such as GS1 Healthcare GTIN Allocation Rules.

If you have a question, refer to the UDI specific FAQs.

For more information contact the GS1 Australia Healthcare team at healthcareteam@gs1au.org.