TGA Issues Draft Guidance on New UDI System
Australia’s Therapeutic Goods Administration (TGA) is asking industry to comment on draft guidance on implementing a unique device identification system for Australia.
The TGA plans on developing a UDI system that follows the EU model and aligns with principles outlined in the International Medical Device Regulators Forum (IMDRF). IMDRF guidance was released guidance in October outlining a single, globally harmonized system to identify devices internationally.
Sponsors of medical devices supplied in Australia would be required to ensure their devices carry UDIs, and that relevant information be entered into the Australian UDI database (AusUDID), the draft guidance says.