Australian UDI Database release notes | Therapeutic Goods Administration (TGA)

We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.

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 database.

Release: 27 November 2024

Area of impact	Description
Pre-Production Data	Remove all UDI record data from the Pre-Production environment. Changes directly impact all users.
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.
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.
Bulk Upload	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.
Machine to Machine HL7 SPL	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	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.

Release: 9 May 2024

Area of impact	Description
ARTG	New functionality to link your ARTG from the ARTG details page on the device viewer.
Machine to Machine HL7 SPL	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	We have fixed an issue that prevented an ARTG from being replaced or added via NPC.
Bulk Upload	Version number of the bulk upload excel template is now verified upon upload.
Portal	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.

Release: 3 May 2024

Area of impact	Description
National Product Catalogue (NPC) submission	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
HL7 SPL Machine to Machine (M2M)	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	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.
Data field	Complete removal of ContainsDEHP field Changes will directly impact users.
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.
Industry impact notes	The UDI Data model has been revised to completely remove the ‘ContainsDEHP’ field Submissions via the Bulk Upload channel will need to use the latest updated template file The UDI records initial Grace Period has now been changed from 7 days to one day in Pre-Production to facilitate testing Records still within the initial Grace Period are now immediately publicly visible to facilitate testing. They will still require an ARTG to be associated with them to be visible A new AusUDID.xsd schema file has been developed for use in the testing and validation of M2M submissions. This will be provided to end users by the UDI Support Team Upon submission, M2M messages are now validated against this new AusUDID schema file by the UDI API Additional code system validation checks have been added Development on the M2M channel has continued to close existing gaps with the implementation spec. Including among others, use of AU Codes for Device Class, Author Handling and SetID/Version Number The search tools on the Manage Supporting Documents section of the portal now filters the results to be ARTG specific The time zone used when validating if the start date of the supporting document has been reached is now Canberra/AEST If you reuse an existing SetID with a different PrimaryDI, we now no longer show that other PrimaryDI in the error message. An issue with NPC Device Class codes has been resolved. Class Im and Class Is are now mapped to NPC values “Class I - measuring" and “Class I - sterile" Fixed up several validation issues with Supporting Documents on the M2M channel. For example, not including an existing supporting document you own after the initial Grace Period now removes it from the device.

Release: 30 November 2023

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

Release: 3 November 2023

Area of impact	Description
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.
Direct Marking DI Issuing Agency	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. 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.
Unit of Use DI and Direct Marking DI	If Device Count is greater than one, then either a Unit of Use DI or Direct Marking DI can be provided, but not both. Changes will directly impact users.
Data field	“Software in a Medical Device” renamed to “Medical Device incorporating software”. Changes will directly impact users.
Data field	“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”. Changes will directly impact users.
Data field	“Commercial Distribution End Date” renamed “Manufacturer Commercial Distribution End Date”. Changes will directly impact users.
Data field	“Package Commercial Distribution End Date” renamed “Manufacturer Package Commercial Distribution End Date”. Changes will directly impact users.
Data field	“Contains DEHP?” renamed as “Device labelled as contains DEHP?” Changes will directly impact users.

Release: 28 September 2023

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

Release: 20 July 2023

Area of impact	Description
ARTG	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.
Latex validation rule	Additional validation error if both “Device contains Latex” and “Device does not contain Latex” are selected. Changes will directly impact users.
Supporting Documents	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
About AusUDID page	Updated to reflect Pre-Production environment. Changes will not directly impact users.
Confidentiality Undertaking page	Updated to reflect Pre-Production environment. Changes will not directly impact users.
ARTG editor	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. Changes will directly impact users.
ARTG Editor	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.

Release: 1 March 2023

Area of impact	Description
AusUDID Pre-Production environment	Platform cleared of test data in preparation for external use. Changes will not directly impact users.

Topics