Sub menu

 

 

Australian UDI Database Production environment: Release notes

Last updated

We have established the Australian Unique Device Identification Database (AusUDID). Australia's Unique Device Identification (UDI) system is supported by AusUDID.

This page details enhancements and fixes to the AusUDID Production environment.

Release: 3 November 2025

Changes do not impact existing UDI records in the AusUDID.

Area of impactDescription
AusUDID portal
  • Various changes to the screens and page flow to enhance system usability including:
    • Changes to mandatory fields and error message prompts
    • Improved accessibility
    • Fixes to commercial distribution functionality
    • Minor wording updates across screens
  • Added ability to lookup a Manufacturer’s name or TBS ID that is associated with a Sponsors ARTG inclusion(s) when creating a new record
  • Improved GMDN browsing experience and updated disclaimer
  • Resolved browser compatibility issues affecting bulk upload templates
  • Changes directly impact all users.
Australian UDI Bulk Upload Template
  • Updated Australian UDI Bulk Upload Template to Version 2.9
  • Enabled AutoFilter on Excel columns
  • Removed requirement to validate Manufacturer name, to prevent errors caused by name variations
  • Changes impact all users of the Australian UDI Bulk Upload Template.
Australian UDI Bulk ARTG to UDI Link Template
  • No changes.
National Product Catalogue (NPC) submission method
  • Enabled association of multiple GLNs with sponsors, resolving organisation verification issues during data submission
  • Changes directly impact all users testing data submission via the NPC.
HL7 SPL submission method
  • Added IP whitelisting instructions to the M2M HL7 SPL User Guide
  • Made minor updates to the M2M HL7 SPL User Guide and M2M HL7 SPL Implementation Specification
  • Removed requirement for validation of Manufacturer name, to prevent errors caused by variations in name
  • Changes impact all users testing data submission via HL7 SPL.
All submission methods
  • Minor changes to ‘Software as a Medical Device’ values to align with sentence case style used in AusUDID
  • Corrected Unit of Use DI optionality when the ‘Direct Marking DI, but exempt?’ and ‘Direct Marking DI different from Primary DI?’ responses are both ‘No’
  • Changes to allow ‘Direct Marked DI’ to match ‘Primary DI’, ‘Secondary DI’, ‘Direct Marked DI’ or ‘Previous DI’ in another UDI record
  • Changes directly impact all users.
Document updates
  • Australian UDI Data Dictionary updated to V1.3
  • Australian UDI Bulk Upload Template updated to V2.9
  • M2M HL7 SPL – Read Me First updated to V1.1
  • M2M HL7 SPL – User Guide – AusUDID updated to V1.3
  • M2M HL7 SPL - Implementation Specification – AusUDID updated to V1.3
  • M2M HL7 SPL – SPL Code List – AusUDID – updated to V1.2
  • M2M HL7 SPL - Example HL7 Submission Comprehensive Elements updated to V1.1
  • M2M HL7 SPL - Example HL7 Submission Sponsor updated to V1.1
  • Changes directly impact all users.

Release: 18 July 2025

Area of impactDescription
AusUDID portal
  • Various changes to the screens and page flow to enhance system usability including:
    • Changes to rename tabs and reorder data fields
    • Added descriptions in UDI Management Centre for sponsors and manufacturers
    • Changes to search screens to include additional information
  • Updated the Department name and logo to the Department of Health, Disability and Ageing
  • Changes directly impact all users.
Australian UDI Bulk Upload Template
  • Updated Australian UDI Bulk Upload Template to Version 2.8
  • Improved the instructions in the ‘Instructions’ sheet
  • Removed incorrect mandatory label from ‘Device labelled as “Not made with natural rubber latex”’ field
  • Changes impact all users of the Australian UDI Bulk Upload Template.
Australian UDI Bulk ARTG to UDI Link Template
  • Updated Australia UDI Bulk ARTG to UDI Link Template to Version 1.05
  • Updates to URL and file names
  • Minor improvements to the ‘Instructions’ sheet
  • Changes directly impact all users of the Australian UDI Bulk ARTG to UDI Link Template.
National Product Catalogue (NPC) submission method
  • The NPC interface is not available for Production use. Users can test their messages in the Pre-Production environment
HL7 SPL submission method
  • Fixed minor issues with supporting documentation, change history when processing HL7 SPL messages and package dates
  • Changes impact all users testing data submission via HL7 SPL. All HL7 SPL users must test their messages in the Pre-Production environment before Production access is granted.
All submission methods
  • Allow Unit of Use DI to be reused across UDI records
  • Changes directly impact all users.

Release: 14 May 2025

Area of impactDescription
AusUDID portal
  • Links to TGA Business Services (TBS) replaced with ‘Sign out’ option.
  • Changes may impact users.
Australian UDI Bulk Upload Template
  • Bulk Upload template updated to version 2.7. Users must use the updated version to submit UDI records. Use of previous versions of this template will result in an error.
  • Updated the template to fix errors that are received when optional worksheets are left blank.
HL7 SPL submission method
  • Support for Machine to Machine HL7 SPL submission method has resumed. Note that any testing must be completed in the AusUDID Pre-Production environment before sending data via HL7 SPL to Production.
  • For more information, please see Machine to Machine (M2M) HL7 SPL
  • Changes impacts users using the HL7 SPL submission method.
National Product Catalogue (NPC) submission method
  • The National Product Catalogue submission method continues to be unavailable.
Supporting Documents functionality
  • Changes impacts users using the Bulk Upload submission method.
  • Added supporting document type ‘Instructions for Use (IFU)’. Users can now add IFUs to the AusUDID.
  • Changes impacts users using the supporting document functionality.

Release: 28 March 2025

Area of impactDescription
AusUDID Production Environment
  • First release of the AusUDID for sponsor use
  • The following features were included in the release:
    • Online portal to submit and manage UDI record(s)
    • Bulk Upload Microsoft Excel Template to submit UDI record(s)
    • Microsoft Excel Template to link ARTG ID(s) to UDI record(s)
    • Search, view, download UDI record(s)
  • The following features are not yet available:
    • Machine to Machine HL7 SPL submission method
    • National Product Catalogue submission method
  • Changes impacts all users.
Product types
Topics