Medical device reforms: Establishment of a Unique Device Identification system

Project overview

On 6 October, as part of the 2020-2021 Budget, the Australian Government announced it will establish a Unique Device Identification (UDI) system for medical devices.

The UDI system will be administered by the Therapeutic Goods Administration (TGA) and the information can be used to support tracking and tracing of medical devices to enable timely clinical and regulatory actions if medical device safety issues are identified.

Establishment of the UDI system, and making the data available to the healthcare and product supply chain systems, will enhance Australia's ability to trace medical devices and strengthen Australia's post-market medical device adverse event system.

The TGA will engage across the broader health system to inform the establishment of the database - from supply, procurement and distribution through to clinical use, patients, consumers and registries.

The consultation process includes ongoing consultation through papers and stakeholder engagement through workshops and discussions. The TGA will engage broadly across the health system, from supply, procurement and distribution through to clinical use, patients and consumers, registries and the use of device information for post-market analysis and research.

Consultations

For more information see Consultations and reviews.