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FAQs

AusUDID Device Registration

What is AusUDID?
AusUDID stands for the Australian Unique Device Identification Database. It is a central government-managed database that stores UDI-DIs and related data for medical devices supplied in Australia. It links UDI records to entries in the Australian Register of Therapeutic Goods (ARTG).
Who can access the AusUDID?
Anyone can search, view, and download public UDI records for free. This includes patients, healthcare professionals, and clinical registries.
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.

 

 

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. ​

 

 

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?
There are 4 methods:

  1. Online Portal – one record at a time.
  2. Bulk Upload Template – up to 200 records.
  3. Machine-to-Machine HL7 SPL – high volume.
  4. 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.