TGA

The Therapeutic Goods Administration (TGA) is implementing an Australian unique device identifier (UDI) for high risk implantable medical devices. The UDI is a set of numbers and characters specific to individual models of devices. The introduction of UDIs was referenced in the Government’s response to the Senate Inquiry into the Number of Women in Australia who have had transvaginal mesh products and in response to recommendations 1, 2, 3, and 5. The objective of UDI is to improve patient safety and post market surveillance. It will be a legal requirement for manufacturers of devices to provide the UDI on labelling and packaging. When used in supply chain, clinical, clinical quality registry (such as the APFPR) and other health systems, the UDI has the ability to:

• link a device to patients and enable faster identification of patients who have been implanted with a device of concern (e.g.: a device with a safety incident or recall related to that device)
• facilitate easier identification and removal of those devices from stocks, storage, and distribution to prevent any further devices of that model being implanted or used
• enable patients and health professionals to access information more easily about the devices that they use.

The TGA released a ‘sandpit’ version of the UDI database on 4 July 2022 for feedback and voluntary compliance commences in January 2023, with mandatory compliance for implantable devices in July 2024. A consultation paper has also been released by the TGA seeking feedback on proposed regulatory changes.

Click here to provide your feedback by 11th October 2022: UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework – Therapeutic Goods Administration – Citizen Space (tga.gov.au)