Consultation: Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework

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 and Aged Care, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government's reforms. The TGA has issued this consultation paper as part of the Government's reform program.

This is the third consultation paper published by the TGA relating to the Australian implementation of a Unique Device Identification (UDI) System for medical devices. It builds on two previous consultation papers, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia, and Consultation: Exploring options for the introduction of an Australian Unique Device Identification (UDI) System.

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

This consultation will inform the policy decisions that will be made by the Australian Government.

Enquiries

For enquiries relating to the consultation document or your submission please email udi@health.gov.au.

All recent TGA consultations can be found at the TGA consultation hub - external site.