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Use the tools and resources on this page to gain a high-level understanding of whether UDI applies to your devices, know what steps are required for compliance, and learn how to use the AusUDID.
Use the flowcharts below to understand whether UDI applies to your devices and when you must comply with UDI requirements.
Prepare for UDI compliance and submitting UDI records to the AusUDID with our comprehensive checklist.
This checklist walks you through steps to prepare, including:
Watch the videos provided to learn about essential UDI concepts and how they apply to your devices.
Learn what a UDI is.
Learn about how UDI is being introduced around the world.
Learn about how UDI works in Australia.
Learn how to apply UDI to different packaging levels.
Learn about UDI Triggers.
Learn about Direct Marking and what devices this applies to.
Learn about Unit of Use and what devices this applies to.
Learn how to access and use the Australian UDI Database (AusUDID) with helpful guides and videos.
Learn about:
Learn how to access the 2 AusUDID environments:
Learn how your organisation type and TGA Business Services (TBS) system role impacts your abilities in the AusUDID.
Key concepts for adding UDI records.
Learn how to add a UDI record to the AusUDID using the online portal.
Learn how to add UDI records to the AusUDID using the Australian UDI Bulk Upload Template.
Key concepts for editing UDI records.
Learn how to edit a UDI record to the AusUDID using the online portal.
Access quick reference guides that offer a clear overview of UDI requirements tailored to different types of devices.
These concise resources are ideal for sharing across your organisation to build awareness and support early learning. Use them as a starting point to understand what is expected for different kinds of medical device and to begin preparing for compliance.
We will continue to add further quick reference guides.
Updates made for the following:
Original publication
Updates made for the following:
Original publication
The Department of Health, Disability and Ageing acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
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