Australia – Australia will develop UDI system for medical devices following new regulatory amendment

Australia’s Therapeutic Goods Administration (TGA) has issued the Therapeutic Goods Amendment (2020 Measures No. 2) Act 2021, which amends the Therapeutic Goods Act 1989. Schedule 2 of the amendment establishes provisions for the creation of a unique device identification (UDI) system to be used for medical devices. It also stipulates that the TGA will establish and maintain its own UDI database, known as the Australian Unique Device Identification Database. Official guidance is expected to provide further details on the implementation of UDI requirements in the near future…