UDI news and updates
Read the latest news and information related to Unique Device Identification (UDI) in Australia.
Subscribe to UDI updates
Subscribe to the UDI mailing list to receive:
- UDI implementation updates
- new and updated guidance
- AusUDID releases and system updates
- upcoming webinars, workshops and stakeholder events
- consultation opportunities and regulatory announcements
To subscribe, email TGASubscriptions@health.gov.au and request to join the UDI mailing list.
Latest updates
UDI consent to supply consultation
We are seeking feedback on a proposed consent to supply process for sponsors who may be unable to meet UDI requirements by the applicable compliance date.
The proposal includes options for a streamlined application process and reduced fees to support the continued supply of devices while organisations work towards compliance.
Consultation period
- Opened: 10 December 2025
- Closed: 23 January 2026
Read UDI - Consent to Supply consultation
Australia's UDI framework now in effect
Australia's UDI regulatory framework commenced on 27 March 2025.
Sponsors and manufacturers can voluntarily comply with UDI requirements and submit data to the Australian Unique Device Identification Database (AusUDID) ahead of mandatory compliance dates.
Access the latest guidance, technical documentation and implementation resources through the UDI Hub.
AusUDID updates
This section includes updates about:
- AusUDID releases and enhancements
- new system functionality
- planned maintenance and outages
- technical documentation updates
- machine-to-machine submission changes
Refer to AusUDID technical resources for the latest release notes and technical documentation.
Upcoming events
We regularly host webinars, workshops and stakeholder forums to support UDI implementation.
Details of upcoming events will be published here when registration opens.
To receive event notifications, subscribe to the UDI mailing list.
Previous updates
Farewell to the UDI Project lead Gary Pascoe!
TGA's UDI Team has said goodbye to a truly valued member as our UDI Project Team Lead, Gary Pascoe, retired on Friday 12 June.
Over the past 6 years, Gary has made an outstanding contribution to the implementation of UDI in Australia. He has been a trusted source of knowledge and humour, both within the TGA and on the international stage.
While he will be greatly missed, the UDI Team will continue to build on the strong foundations he has helped create.
Thank you Gary - we wish you all the very best for your next adventure!
29 May 2025
In March 2025, after more than 4 years of work by many in the TGA, Australia’s UDI system for medical devices was introduced through updates to the Medical Device Regulations.
On Thursday 29 May, TGA staff and partners joined sponsors, industry bodies and overseas experts in celebrating the official launch of Australia’s UDI system. The launch took place at the Regulatory and Technical Consultative Forum for Medical Devices (RegTech) meeting.
With the UDI launch, manufacturers supplying medical devices in Australia will identify their devices through bar coding on all packaging and labelling and submit this data to the TGA. Mandatory UDI compliance for implanted devices will start from July 2026. The UDI information can be used in hospital systems, patient records including MyHealth Record to clearly identify the model of medical device used or implanted. A public database of UDI information will be maintained by the TGA, allowing patients to access the relevant information about their device.
27 March 2025
Australia’s UDI regulatory framework is now in effect.
The UDI amendments to the Medical Device Regulations have been approved and finalised by the Australian Government and registered on the Federal Register of Legislation on 24 March 2025 (Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025.
You can now voluntarily comply with UDI requirements until the compliance start date for your medical device(s) or in vitro diagnostic (IVD) device(s). You can also submit your UDI data to the Australian UDI Database (AusUDID).
For more information on AusUDID, see: Australian UDI Database.
To support you complying with the UDI requirements and using the AusUDID, we have published a range of resources. These include:
- UDI Guidance
- UDI Implementation Timing Guidance
- Australian UDI Data Dictionary
- Bulk Upload Microsoft Excel Template
- Glossary.
We have also updated the UDI hub with the most current information, including:
- Sponsor and manufacturer obligations
- UDI labelling requirements
- Information on UDI requirements for specific medical device types
- How to access the AusUDID and methods for submitting data to the AusUDID
- How to use the AusUDID to find information about medical devices
- Infographics and small videos to help general understanding of UDI and our requirements.
We will continue to keep our UDI information up to date with regular publishing of new and updated resources and support products to the UDI hub.
The initial release of the AusUDID, only offers 2 methods for submitting UDI records to the TGA: the online portal and the Bulk Upload template.
The 2 machine to machine methods for submitting UDI data - via HL7 SPL and the National Product Catalogue (NPC) - are not yet available. We will publish more information about these submission methods, including user guides and implementation specifications in April 2025.
12 December 2024
We have published the draft UDI Guidance, Complying with the Unique Device Identification regulations for medical devices, on the TGA Consultation Hub for external review.
We have drafted this guidance to help sponsors and manufacturers of medical devices understand their regulatory obligations under therapeutic goods legislation.
Specifically, this information covers:
- medical devices and in vitro diagnostic (IVD) medical devices included in UDI regulations
- labelling requirements
- data submission requirements
- specific device requirements.
This document outlines the processes to get and apply a UDI and submit and maintain UDI data in the Australian UDI Database (AusUDID).
You can find the document and provide your comments via our survey Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices.
29 November 2024
We deployed a major package of enhancement to the AusUDID Pre-Production environment on 27 November, 2024 and the Pre-Production version is now re-open for sponsor use and feedback.
These enhancements include:
- Changes to the Australian UDI Database (AusUDID) based on the multiple sponsors for the same medical device consultation
- Changes to the AusUDID database structure
- Fixes to system issues
- Removal of all existing data
- Updates to the Bulk Upload Microsoft Excel Template.
What this means for sponsors and manufacturers
The AusUDID Pre-Production environment is now available for use. You can submit individual UDI records through the online portal, or many at a time with the Bulk Upload template. Because of the changes to the database, the Bulk Upload template has changed and you will need to download and use Version 2.3 of the template. The new template is available in the AusUDID portal.
The Machine to Machine (M2M) submission methods
HL7 SPL and National Product Catalogue (NPC) submission methods are still being system and regression tested and should not be used at this time. A future release for both M2M submission methods, and the associated technical documentation, is coming soon. We will publish an update when these M2M capabilities are available.
The Australian UDI Data Dictionary has also been updated to reflect the system changes. You can find Version 0.9 on the UDI Hub on our website.
Contact us
If you cannot find the information you need, contact UDI@health.gov.au or request a meeting for complex UDI implementation or AusUDID enquiries.