Submission to the Therapeutic Goods Administration regarding the establishment of Unique Device Identification System for medical devices
Recent device failures and subsequent findings have revealed a poorly regulated industry that has put consumers at considerable risk of harm, including those with persistent and chronic pain. In particular, the inability of regulators to trace devices has been a systematic failure of our health and safety regulatory regime. Painaustralia is therefore supportive of the proposed introduction of the UDI System in Australia, including the development of the UDI database (AusUDID). We also support the proposal that the TGA be responsible for developing and maintaining the UDI database, and the AusUDID.