Consultation on exploring options for the introduction of an Australian Unique Device Identification (UDI) System

This consultation closed on 24 December 2020.

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program.

This is the second consultation paper relating to the proposed Australian implementation of a Unique Device Identification (UDI) System for medical devices. It builds on the first consultation paper, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia.

We invite you to review the consultation paper and provide a response using our online survey, both of which are accessible through our consultation hub. We appreciate all views, so if you would prefer to respond by email or written document, you can find further details on the hub.