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AusUDID Journey

Your Journey to AusUDID Submission

To meet Australia’s UDI requirements, sponsors and manufacturers must submit accurate device data to the Australian UDI Database (AusUDID). The steps below outline how to prepare for and streamline your journey to compliance.

  1. Understand the UDI Requirements

Familiarize yourself with the Australian UDI regulatory framework, including timelines, device classification, data elements, and submission processes. 

  1. Assess and Classify Your Devices

Determine the UDI compliance timelines based on the risk class of your medical devices (e.g., high-risk and implanted devices must comply by July 2026). 

  1. Engage with UDI Issuing Agencies

Work with an accredited UDI Issuing Agency (e.g., GS1) to generate compliant UDIs for your products. 

  1. Validate and Submit UDI Data to AusUDID

Collect and structure the required UDI data elements and submit them to the Australian Unique Device Identification Database (AusUDID).

  1. Train Teams and Educate Stakeholders

Provide training for regulatory, supply chain, and commercial teams, and educate your customers about upcoming UDI changes.