UDI: News and updates

Upcoming events

We continue to engage with sponsors, manufacturers, consumers, and healthcare professionals through a series of UDI webinars and Working Groups.

We will publish details of upcoming events on this page.

News and updates

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 - external site).

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 - external site.

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.

You can find the full release notes on our website.

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.

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