Australian UDI Database Pre-Production environment: Release notes

Read the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.

Last updated

12 October 2026

On this page:

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 Pre-Production environment.

Release: 12 October 2026

Changes do not impact existing UDI records. No action is required by users.

Area of impact	Description
All submission methods	Upgraded to .NET 10 to maintain ongoing Microsoft support as previous .NET versions reach end of support in November 2026. Changes do not impact users.
AusUDID Portal	Improved screen prompts when creating or managing UDI records using the AusUDID Online Portal. Removed ARTG address information from UDI records while discrepancies in the displayed data are being reviewed. ARTG address information remains available through the ARTG public summary. Changes impact all users of the AusUDID Portal.

Release: 3 August 2026

Changes impact a small number of UDI records affected by ARTG sync issues. No action is required by users.

Area of impact	Description
All submission methods	Patch applied to restore inadvertently omitted data due to ARTG synchronisation issues. Changes directly impact all users regardless of submission method used.
AusUDID Portal	Patch applied to restore download functionality, and improved the performance, for browse and search results. Users can now view or download up to 5,000 UDI records at a time. Download files no longer include the name of the organisation who last edited the UDI record. Added Publish column to enable sorting of results on the Devices tab. Improved the readability of the Full UDI record Excel download by including the version number and version status on each worksheet. This only applies to downloads for the View the change history of my UDI records on the Manage Data tab. Changes impact all users of the AusUDID Portal.
Australian UDI Sponsor Link Template	Patch applied to resolve auto publishing issues that occurred when using the To Publish worksheet. Since the June release, when the scheduled publish date was reached the draft UDI record was published but not removed from the My Drafts display. Published UDI records will no longer incorrectly display in the My Drafts tab of the AusUDID online portal. Changes impact all users of the Australian UDI Sponsor Link Template.

Release: 9 June 2026

No impact - Changes do not impact existing UDI records in the AusUDID Pre-Production environment.

Area of impact	Description
All submission methods	Modified validation rules to allow UDI records to contain both a Direct Marked DI and Unit of Use DI (aligned with the Australian UDI Data Dictionary). Improved routine synchronisation performance with other TGA systems. Changes directly impact all users regardless of submission method used.
AusUDID Portal	Enhanced the search feature to improve relevancy of search results when searching on multiple keywords. Searching using double quotation marks will show results that include all words within the double quotation marks at the top of the search results list. For example, searching “medical devices” will display all results with “medical devices” as a keyword at the top of the search results list. Added Manage data tab to the UDI Management Centre for current and future UDI record management features. Implemented the View the change history of UDI records feature on the Manage data tab. This allows the user to view updates and corrections of your UDI records, including changes from other organisations in a multiple sponsor scenario. Implemented the Delete test UDI records in bulk feature on the Manage Data tab to allow bulk deletion of UDI records. Please note: this feature is only available in the AusUDID Pre-Production environment to support testing. It will not be available in AusUDID Production. Replaced CSV downloads with Excel format for Downloads. Improved file naming and consistency across all download formats. This allows the user to receive the same information regardless of the download format they choose. Extended the download capability to My UDI records, My drafts, Link my ARTG ID and Manage data. This enhances options for downloading records filtered to your organisation. Added download capability to Browse by GMDN to support healthcare and public users. Download capability relocated from the Supporting documents page to the History page. This allows users to access all version history in one location. Changes impact all users of the AusUDID Portal.
Australian UDI Bulk Upload Template	Updated Australian UDI Bulk Upload Template to Version 2.9.1. Version 2.9.1 includes a fix to the cell format of the Sponsor Package Commercial Distribution End Date on row 606 onwards. Please note: If you are submitting more than 600 Package identifiers on the Sponsor Package Commercial Distribution End Date worksheet you must use version 2.9.1 of the template. If not submitting more than 600 Package Identifiers you can use either version 2.9 or version 2.9.1. Users are not impacted unless they wish to use the Sponsor Package Commercial Distribution End Date data element when submitting their data.
Australian UDI Sponsor Link Template	Renamed the template from Australian UDI ARTG ID Bulk Mappings Template to Australian UDI Sponsor Link Template. Updated Australian UDI Sponsor Link Template to Version 2.0. Improved the template to allow users to add or edit all Sponsor specific data. Please note: the following known issues with this template: The number of rows that can be submitted in a single worksheet is limited. The current maximum is 50 rows per worksheet. The ‘To Publish’ worksheet does not function as intended and should not be used. We are continuing to investigate improvement options. Changes impact all users of the Australian UDI Sponsor Link Template.
National Product Catalogue (NPC) submission method	Removed Manufacturer GMDN value from data submission to prevent submission errors. Changes impact all users of the NPC
HL7 SPL submission method	Please note: There is no impact to M2M HL7 SPL submissions based on the updates to the M2M HL7 SPL – Implementation Package - AusUDID.
Document updates	Australian UDI Data Dictionary updated to V1.4 Australian UDI Sponsor Link Template updated to V2.0 Australian UDI Bulk Upload Template updated to V2.9.1 M2M HL7 SPL – Implementation Package – AusUDID updated to V1.5 to reflect changes to support processes only. The following documents within the package have been updated: M2M HL7 SPL – Read Me First updated to V1.4 M2M HL7 SPL – User Guide – AusUDID update to V1.5 M2M HL7 SPL – Implementation Specification – AusUDID updated to V1.5 M2M HL7 SPL High Level Overview updated to V1.1

Release: 8 April 2026

Inactive manufacturers previously displayed on UDI records will be removed. No action is required by users.

Area of impact	Description
ARTG AusUDID link	Patch applied to resolve system issue affecting ARTG inclusions created on or after 11 March 2026 that resulted in these ARTGs not appearing in the AusUDID. Changes impact all users.
AusUDID Portal	Following the patch, the previous update to remove inactive manufacturers details being incorrectly displayed on the ARTG details screen will support all UDI records. Changes impact all users.

Release: 13 February 2026

Changes do not impact existing UDI records in the AusUDID Pre-Production environment.

Area of impact	Description
Grace Period	The Grace Period in the AusUDID Pre-Production environment remains at one day to support timely testing of UDI record submissions and the application of UDI Trigger rules and corrections. The Grace Period in the AusUDID Production environment was extended from 7 days to 30 days to allow users additional time to correct errors with their initial data.
All submission methods	No changes that impact all the submission methods. See individual submission method notes.
AusUDID Portal	Updated to remove inactive manufacturers details being incorrectly displayed on the ARTG details screen. Implemented performance and security enhancements. Changes impact all users.
National Product Catalogue (NPC) submission method	Removed the ability to submit UDI package configuration changes during Grace Period to prevent errors or loss of package data due to unintended differences in the NPC message. If a UDI package configuration requires change, the changes need to be made using the AusUDID Portal. Resolved issues when submitting a Unit of Use DI for some NPC configurations. Changes impact all users of the NPC channel submission method.
HL7 SPL submission method	Removed the ability to submit UDI package configuration changes during Grace Period to prevent errors or loss of package data due to unintended differences in HL7 the message. If a UDI package configuration requires change, the changes need to be made using the AusUDID Portal. Changes impact all users of the HL7 SPL channel submission method.
Document updates	M2M HL7 SPL – Implementation Package – AusUDID updated to V1.4. with the following documents in the package: M2M HL7 SPL – Read Me First updated to V1.3; references new version of the M2M HL7 SPL – Implementation Specification – AusUDID. M2M HL7 SPL - Implementation Specification – AusUDID updated to V1.4; clarifies the process for changing UDI package configuration information. Changes impact all users of the HL7 SPL channel submission method.

Release: 29 October 2025

Changes do not impact existing UDI records in the AusUDID.

Area of impact	Description
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. Updated page header to green in the AusUDID Pre-Production environment for easier identification. 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 impact	Description
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 ready for Pre-Production testing with GS1 Updated error messages to provide more specific information Fixed issues including: where omitting a clinical size value was incorrectly defaulting to zero issues identified with replacing existing supporting documents issues identified for ‘Device required to be labelled as “Containing natural rubber latex or dry natural rubber”’ and ‘Device labelled as “Not made with natural rubber latex”’. Changes directly impact all users testing data submission via the NPC.
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 submission methods	Allow Unit of Use DI to be reused across UDI records Changes directly impact all users.

Release: 14 May 2025

Area of impact	Description
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. Changes impacts users using the Bulk Upload submission method.
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 Submitting UDI records using 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	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 impact	Description
AusUDID Portal	Useability improvements – updates to page headings, menu labels and on-screen text Device Overview page – removed device status and made changes to display of ARTG details Device History page – added organisation name for each history entry About AusUDID page – minor editorial changes Browse by GMDN feature re-enabled Supporting Documents – removed IFU from available document types AusUDID page footer – added links to terms of use and disclaimers Device export files – updated display of GMDN definition in device export files CSV export files – fixed an issue with device commercial distribution end date in the file Changes may directly impact all users.
Australian UDI Bulk Upload Template	Updated to Version 2.6 Changes may directly impact users.
Australian UDI Bulk ARTG to UDI Link Template	Updated to Version 1.04 Changes may directly impact users.
HL7 SPL submission method	Full system and regression testing is still underway as at time of this release.
National Product Catalogue (NPC) submission method	Full system and regression testing is still underway as at time of this release.

Release: 31 January 2025

Area of impact	Description
AusUDID Portal	Updates to History tab to not display user names and ensure update actions are shown correctly. Minor fixes and enhancements and improvements to system performance. Note that there is a known issue with the Browse by GMDN feature when searching for devices. This will be resolved in a future release. Changes may directly impact all users.
Australian UDI Bulk Upload Template	Updates to the Bulk Upload Microsoft Excel template (v2.4) to: Address an issue with the Sterilisation dropdown Address an issue where isKit was the only missing mandatory field Include additional validation where conflicting values are provided for Unit of Use DI and Direct Marked DI More comprehensively display field validation error messages Address minor theming inconsistencies. Changes directly impact all users. All users must download the new version of the Bulk Upload Microsoft Excel template (V2.4) from the AusUDID. You will not be able to upload data if you use an older template.
HL7 SPL submission method	No change, noting full system and regression testing is still underway as at time of this release.
National Product Catalogue (NPC) submission method	No change, noting full system and regression testing is still underway as at time of this release.

Release: 27 November 2024

Area of impact	Description
AusUDID data	Remove all UDI record data from the Pre-Production environment. Changes directly impact all users.
AusUDID Portal	User interface updated to support multiple sponsor functionality. Edit function automatically switches to a Correction when a trigger field is changed, or when a common field is changed on a Multiple Sponsor record Incomplete mandatory fields now highlighted in red ARTG ID text (not a link) shown when a UDI record is linked to a Cancelled ARTG record Removal of Scan a Barcode functionality. Removal of Device History changes diff viewer Full system and regression testing completed on this functionality Changes may directly impact all users.
Australian UDI Bulk Upload Template	Updates to the Bulk Upload Excel template (v2.3) to incorporate new and changed data fields and to apply editorial updates Updates to the Bulk ARTG Excel template (v1.03) to apply editorial updates Full system and regression testing completed on this functionality. Changes directly impact all users. All users must download the current version of the Excel templates from the AusUDID.
HL7 SPL submission method	Development changes for multiple sponsor functionality Note that full system and regression testing has not been undertaken on this functionality as at time of release. Changes directly impact users of the Machine to Machine HL7 SPL submission method.
National Product Catalogue (NPC) submission method	Development changes for multiple sponsor functionality Note that full system and regression testing has not been undertaken on this functionality as at time of release. Changes directly impact users of the NPC submission method.
Data Model	UDI Record - Version Timestamp, Version Number and Version Status added to support recording versioning and channel information Revised to support multiple sponsors functionality. Refer to Data Dictionary v0.9 for full details of the current data elements implemented across all 4 submission methods. https://www.tga.gov.au/sites/default/files/2024-04/ausudid-data-dictionary.xlsx Changes will directly impact all users.
Multiple Sponsor	Modified edit rules for which role can edit some data elements in a multiple sponsor scenario UDI record updates – devices are no longer restricted to a single sponsor during Grace Period. When multiple sponsors are associated with a UDI record, changes to common fields outside of Grace Period require a Correction. Sponsor-specific fields – Catalogue Number, ARTG, Supporting Documents, Device Commercial Distribution End Dates and Package Commercial Distribution End Dates. These can be modified by a sponsor at any time without the use of a Correction Manufacturer Global Medical Device Nomenclature (GMDN) and device risk class are optional and can be different to the values stored on the corresponding ARTG inclusion. These will be included in sponsor views and downloads. No sponsor supplied GMDN and device risk class will be included in public views or downloads Packaging – modified to record the manufacturer's standard packaging configurations as well as sponsor-specific packaging configurations Catalogue number - changed from a single-entry field to multiple, allowing for different catalogue numbers for each sponsor. Each catalogue number is associated with a single ARTG Commercial Distribution End Date - changed from a single-entry field to multiple, supporting different distribution dates for each sponsor. Each date is associated with a single ARTG Package Commercial Distribution End Date - changed from a single-entry field to multiple, supporting different packaging for each sponsor. Each Date is associated with a single ARTG Changes may directly impact all users.

Release: 9 May 2024

Area of impact	Description
AusUDID Portal	New functionality to link your ARTG from the ARTG details page on the device viewer. A ‘back to search results’ link is now incorporated into several site pages to preserve navigation and search history. Sort order is now maintained when exporting search results from the devices search screen. Addition of a confirmation screen when cancelling a device’s scheduled publishing. Minor name changes of various export files to make the presentation of dates consistent.
Australian UDI Bulk Upload Template	Version number of the bulk upload excel template is now verified upon upload.
HL7 SPL submission method	Additional validation has been added for the Author Code within HL7 SPL messages. The environment name (for example, Pre-Production) has been added in the HL7 SPL response header. Allow immediate publishing of HL7 SPL records if a future publish date was provided and then updated to a current or past date in a subsequent message.
National Product Catalogue (NPC) submission method	We have fixed an issue that prevented an ARTG from being replaced or added via NPC.

Release: 3 May 2024

Area of impact	Description
National Product Catalogue (NPC) submission method	Fix issue where AusUDID is removing leading zeroes from the GLN, resulting in invalid NPC response message being returned to GS1. Leading zeroes will now be retained for the GLN Changes will not impact users of other submission methods.

Release: 14 March 2024

Area of impact	Description
AusUDID Portal	Disallow manually entering past dates to be used as future publish dates Fix issue with undesirable table sorting after correction request Update to About/Confidentiality UDI Page Updated Microsoft Excel Bulk Upload template Fix issue of filtering of content for the delta download files not being applied Changes will directly impact users.
HL7 SPL submission method	Added timestamp in M2M error messages Amendments to Restricted number of uses field Amendments to DI and GMDN Codes Improvements to Author, OIDs and document effective time Removed reference to PrimaryDI when reusing SetID Enforce document root Fix incorrect error when brand name is left blank Improvements to validation rules for PrimaryDI, SecondaryDI and Direct Marking fields Fix validation error messages for Single Use Fix error message when providing more than one PreviousDI Fix error messages for Manufacturer Commercial Distribution End Date field Fix error message for Device Size Text Clinical Size Creation of AusUDID XSD. Added API enforcement of schema SetID/Version number feature Validate PackageDI Issuing Agency matches the Primary Disallow complete removal of ARTG IDs during Grace Period Fix to Author section of M2M message Disallow use of Correction reason in non-correction requests Changes will directly impact users.
National Product Catalogue (NPC) submission method	Minor fix for NPC numeric fields Fix for reference data for Device Classes Minor fix with UOM error messages Improvements to corrections when organisation has multiple agents Improved validation of Information Provider section. Changes will directly impact users.
Supporting Documents functionality	ARTG Centric Supporting Documents Search on Manage Documents page Fix validation issues for Supporting Document dates, use AEST for validation purposes M2M: If existing documents are not included after Grace Period, they are removed Changes will directly impact users.
Grace Period	Change Grace Period to 1 day Amendment to make records within Grace Period visible to the public Changes will directly impact users.
All submission methods	Complete removal of ContainsDEHP field Changes will directly impact users.

Release: 30 November 2023

Area of impact	Description
AusUDID platform architecture	Upgraded to improve security and resilience. Changes will not directly impact users.

Release: 3 November 2023

Area of impact	Description
Australian UDI Bulk Upload Template	Updated to version 1.7. Updated template incorporates the latest reference value changes and a new Direct Marked DI Issuer column. The number of UDI records per file increased to 200. Changes will directly impact users.
All submission methods	Direct Marked DI is not allowed to contain a value if “Device Subject to Direct Marking (DM) but Exempt” is True. If Direct Marked DI is provided, Direct Marked DI Issuing Agency must also be provided as it may or may not be the same as the Primary DI Issuing Agency. If Device Count is greater than one, then either a Unit of Use DI or Direct Marking DI can be provided, but not both. “Software in a Medical Device” renamed to “Medical Device incorporating software”. “Restricted number of uses” renamed “Restricted Number of Reuses” and validation amended to “Must be a number between 1 and 999999 if Single Use is No, else leave blank”. “Commercial Distribution End Date” renamed “Manufacturer Commercial Distribution End Date”. “Package Commercial Distribution End Date” renamed “Manufacturer Package Commercial Distribution End Date”. “Contains DEHP?” renamed as “Device labelled as contains DEHP?” Changes will directly impact users.
Corrections functionality	Users may now request a correction via the portal for the Machine to Machine (M2M) and National Product Catalogue (NPC) channels. Once a correction request is submitted, the next record update on the selected channel sent by the requestor organisation will automatically be treated as a correction. Changes will directly impact users.

Release: 28 September 2023

Area of impact	Description
AusUDID Portal	Introduction of Corrections functionality via the Online Portal. Users now able to use ‘Make a Correction’ functionality via the Online Portal. Any data submitted into AusUDID Pre-Production will now have a 7-day window in which changes can be applied before the trigger rules apply. Feedback module removed. Users now unable to submit feedback via the module. Updated Manufacturer Editor to provide clearer user experience. Updated ARTG Editor to provide a clearer user experience. Changes will directly impact users.
HL7 SPL submission method	Introduction of Machine to Machine HL7 SPL to the platform. Users now able to submit data via this channel. Changes will directly impact users.

Area of impact

Description

AusUDID Portal

Introduction of Corrections functionality via the Online Portal.
Users now able to use ‘Make a Correction’ functionality via the Online Portal.
Any data submitted into AusUDID Pre-Production will now have a 7-day window in which changes can be applied before the trigger rules apply.
Feedback module removed. Users now unable to submit feedback via the module.
Updated Manufacturer Editor to provide clearer user experience.
Updated ARTG Editor to provide a clearer user experience.
Changes will directly impact users.

HL7 SPL submission method

Introduction of Machine to Machine HL7 SPL to the platform. Users now able to submit data via this channel.
Changes will directly impact users.

Release: 20 July 2023

Area of impact	Description
AusUDID Portal	Changes to device records to require an ARTG to be present on the record for the record to appear in public search results. Changes will directly impact users.
All submission methods	Additional validation error if both “Device contains Latex” and “Device does not contain Latex” are selected. Changes will directly impact users.
Supporting Documents functionality	Introduction of dedicated Supporting Documents section in the Device Creator and Editor. Documents can be accessed via the Find Supporting Documents tab in the menu bar. Changes will directly impact users.

Release: 15 June 2023

Area of impact	Description
AusUDID Portal	Updated ‘About AusUDID’ page to reflect Pre-Production environment. Updated ‘Confidentiality Undertaking’ page to reflect Pre-Production environment. Updated the Device Create/Edit screens to relocate the ARTG Editor. ARTG Editor now in its own dedicated section which appears prior to the manufacturer linking screen. Added validation rule to make ARTG required for sponsor/manufacturer organisations who enter a different manufacturer to their own organisation. Changes will directly impact users.