On March 24, 2025, Australia’s Unique Device Identification (UDI) regulatory framework came into effect to enhance patient safety and improve the efficiency of the regulatory system, including the management of post-market safety activities such as recalls. In line with this, the Therapeutic Goods Administration (TGA) released guidance on UDI requirements and compliance with identification timel..

The Therapeutic Goods Administration (TGA) of Australia implemented the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Amendment Determination (No.2) 2024 on September 18, 2024.  This amendment modifieds the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018 (“the Principal Determination”..