UDI for Australian healthcare: Executive summary

The Unique Device Identification (UDI) system is a key element of Australia’s medical device regulatory framework. It can strengthen patient safety, improve device traceability, and enable rapid action during recalls or market actions.

UDI supports healthcare providers by making it easier to identify, manage and monitor medical devices within clinical workflows and information systems. It also assists in recording and tracking specific devices used on or implanted into patients.

To realise these benefits, UDI must be integrated across all stages of the healthcare system and be captured in processes and systems that manage product or patient data.

This executive summary explains the benefits of implementing UDI and how it can be integrated into processes across the entire device lifecycle – from manufacturing and distribution to clinical use and recall management.

Take the next step toward faster device identification, improved recall management, and greater confidence in patient care:

• Share this executive summary with your colleagues, networks and executive teams
• Contact the TGA at UDI@health.gov.au for implementation support
• Access essential resources on the UDI Hub:
  • UDI: Information for healthcare providers
  • Overview of UDI for Australian healthcare