FAQs
AusUDID Device Registration
What is AusUDID?
Who can access the AusUDID?
What are the UDI compliance start dates for medical devices?
- Class III and Class IIb: 1 July 2026 ​
- Class IIa: 1 July 2027 ​
- Class Is: 1 July 2028 ​
What are the UDI compliance start dates for IVDs?
- Class 4 and Class 3: 1 July 2028 ​
- Class 2 and Class 1: 1 July 2029
What’s the key difference between sponsors and manufacturers in AusUDID?
- Sponsors are legally responsible and can link ARTG IDs.
- Manufacturers can create and publish UDI records but cannot link ARTG IDs.
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Can sponsors voluntarily comply with UDI requirements before the compliance start date?
Yes, sponsors can voluntarily meet UDI requirements before the mandatory compliance start date. ​
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What are the transitional arrangements for devices supplied under EU MDD certificates?
Devices with extended EU MDD certificates must meet UDI requirements by the transitional dates:
- Class III and Class IIb implantables: 1 January 2028 ​
- Class IIb non-implantables, Class IIa, Class Is: 1 January 2029 ​
What happens if devices transition to EU MDR certification before the transitional dates?
Devices must meet Australian UDI requirements at the time of transition. ​
What are the submission requirements for Sponsors for UDI records?
Sponsors must:
- Submit UDI records to the AusUDID within 30 days of the device being supplied in Australia. ​
- Ensure UDI records are up-to-date while the device is in distribution. ​
What are the methods to submit device data to AusUDID?
- Online Portal – one record at a time.
- Bulk Upload Template – up to 200 records.
- Machine-to-Machine HL7 SPL – high volume.
- Machine-to-Machine via NPC – med-high volume for NPC users.
What are the environments available for AusUDID?
There are two environments:
- Production: The live, compliant environment for official UDI submissions.
- Pre-Production: A testing environment used for training and validation.
Can I test device submissions to AusUDID before going live?
Yes. Use the Pre-Production environment to test submissions before submitting to Production.
Can UDI records be deleted?
No. Records remain in AusUDID indefinitely. If a device is no longer supplied, update the Sponsor Commercial Distribution End Date.
What is the Grace Period for UDI records?
It is a 7-day window after initial publication during which any changes, including UDI Trigger elements, can be made freely.
What are UDI Trigger vs. Non-Trigger elements?
- UDI Trigger elements require a new UDI-DI if changed after the Grace Period.
- Non-Trigger elements can be updated at any time.
Can multiple sponsors share a UDI-DI in AusUDID?
Yes. Multiple sponsors of the same device can share the same UDI record in AusUDID to ensure data consistency. Sponsors can only edit their own sponsor-specific data elements.
What happens if a manufacturer publishes a UDI record?
It remains in a ‘published but not publicly available’ state until a sponsor links an ARTG ID.