Medical device reforms: establishment of a UDI system

Project overview

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

We will administer the UDI system. The information will support tracking and tracing of medical devices.

This allows for timely clinical and regulatory actions if safety issues are discovered.

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.

We 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.

We will engage broadly across the health system, from supply, procurement and distribution through to clinical use, patients, consumers and registries and the use of device information for post-market analysis and research.

Consultations