AusUDID Journey

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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.
Prepare an internal action plan

Understand the UDI Requirements
Familiarize yourself with the Australian UDI regulatory framework, including timelines, device classification, data elements, and submission processes. 
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). 
Engage with UDI Issuing Agencies
Work with an accredited UDI Issuing Agency (e.g., GS1) to generate compliant UDIs for your products. 
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).
Train Teams and Educate Stakeholders
Provide training for regulatory, supply chain, and commercial teams, and educate your customers about upcoming UDI changes.

Gather and validate data required for GUDID

Gather and validate data required for GUDID using Innovit’s GUDID Connector in a Pre-Production environment which provides all the attributes, code lists and business rules based on the GUDID Data Elements Reference Table and HL7 SPL Implementation Specifications and Business Rules.

Request a Pre-Production GUDID Account.

Fill out the GUDID New Account Request form

Fill out the GUDID New Account Request form accurately and identify Innovit as your Third-Party Submitter by providing Innovit’s DUNS number during your GUDID account request. This authorizes Innovit to submit GUDID information on your behalf and will be associated to your labeler account.

Allocate 2-3 weeks for the FDA to provision the Pre-Production Account.

Refer GUDID account setup questions to the FDA UDI Help Desk.

Request an FDA Electronic Submissions Gateway (ESG)

Request an FDA Electronic Submissions Gateway (ESG) Account to submit HL7 SPL files.

Contact the ESG Help Desk for ESG account setup questions.

Allocate 4 weeks for the account to be provisioned.

Complete the GUDID test scenarios

Once ESG and GUDID Pre-Production accounts are established: Use Innovit’s GUDID Connector to complete GUDID testing using the test scenarios specified in GUDID_TestCriteriaProduction.pdf.

Log in to your GUDID Pre-Production Account and verify that your records are submitted correctly.

Send the following Information to the FDA UDI Help Desk for review and production account approval:

For each test scenario:

The CoreID and Primary DI Number. CoreID is assigned by the FDA ESG for each submission and is included in ACK2 and ACK3 messages.

For Scenario 1a, 2a and 3a in GUDID_TestCriteriaProduction.pdf, the GUDID Data Elements that have changed, value before change, and value after change.

The FDA UDI staff will review the information and a GUDID Production Account will be established after a successful review.

Validate, migrate and submit your data

Once GUDID Production accounts are established:

Ensure the data you have gathered and validated is the latest for submitting to GUDID. Migrate the data from Innovit’s GUDID Connector Pre-Production Environment to Production Environment.

If you are migrating from another Third-Party Submitter’s system to Innovit’s GUDID Connector, align Set ID, Core ID and Version ID information for your device records.

Start submitting trusted data to GUDID reliably and efficiently!

Celebrate