The Australian Government, through the Therapeutic Goods Administration (TGA), is implementing the Australia Unique Device Identification (UDI) system. The UDI framework is intended to improve the identification, traceability, and safety of medical devices, enhance post-market surveillance, and support regulatory oversight.
Sponsors and manufacturers are required to submit UDI and related data to the Australian UDI Database (AusUDID), the central repository for information on medical devices supplied in Australia.
The HIBC Supplier Labeling Standard (SLS) provides a flexible alphanumeric UDI system that allows manufacturers to use their existing product codes, thereby simplifying implementation, supporting regulatory compliance, and improving device traceability.
The HIBCC Labeler Identification Code (LIC) is a unique company identifier used with your existing product codes and production information to create UDI-DIs and UDI-PIs.
Click here to view the HIBCC LIC Fee Schedule.
Generate your UDIs using the HIBC UDI-Builder. For guidance, visit our UDI & Labeling Resource Center.
Source: www.tga.gov, click here to view the Timeframes for supplying UDI compliant medical
devices in Australia
For more information, email us at info@hibcc.org.