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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.

What is a Grace Period?

Grace Period is a time window after the DI Record Publish Date which is intended for labelers to have the opportunity to review and correct data of published Device Identifier (DI) records in the GUDID before they are made available to the public. The grace period begins the day after a device’s GUDID DI Record Publish Date and is currently set at 7 days. During the grace period, labelers may edit and correct all data elements for the DI record. Once the grace period expires, certain data elements can no longer be added, edited or deleted.

Is there any way to correct data after the Grace Period?

Yes, the FDA introduced a feature in March 2018 for a GUDID Coordinator user to “unlock” device records in the GUDID Web Portal to make error corrections for Published device records after their grace period. The records that are unlocked will remain unlocked for 5 calendar days (starting the day after the record is unlocked). Corrections to these records can be done via the GUDID web interface or M2M via the GUDID HL7 SPL submission option. Records will be locked again once the edits that are submitted are correctly processed (or after completion of the 5 calendar day unlock period, whichever is earlier). Updated information will be released to public users on AccessGUDID and OpenFDA on the next scheduled release date. All prior published versions of a given record will remain accessible on AccessGUDID and OpenFDA as device record history.

Did You Know?

26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.

What’s the difference between a Device Identifier and a Production Identifier?

UDI is made up of both Device Identifier (DI) and Production Identifier (PI).

  • Device identifier (DI) is a static identifier that identifies the labeler and a specific version or model of a device.
  • Production identifier (PI) is a dynamic identifier that is variable depending on the specific production of the device. It can be a lot/batch number, serial number, expiration date, manufacturing date or distinct identification code (for a human cell, tissue, or cellular and tissue-based products that are regulated as a device).

Medical devices need to be a labeled with a UDI containing both the Device Identifier (DI) and Production Identifier (PI) in human and machine-readable form.

Do I need to submit the Production Identifier to the GUDID?

No. GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the primary key to obtain medical device information in the database. The Production Identifiers (PIs) do not need to be submitted to GUDID. However, you need to submit to GUDID what types of Production Identifier will be used for the control of the device (i.e. a lot/batch number, serial number, expiration date, manufacturing date or distinct identification code)

How can Innovit help?

Innovit is the leading provider of UDI data compliance solutions and has enabled several global device manufacturers and labelers to meet their UDI compliance deadlines by providing a direct connector to the GUDID for M2M data submission or via our GDSN Multi-Connector for customers who prefer using GDSN as the standard for submitting their data.

Try out our GUDID playground solution or contact our GUDID experts to get started.