Voluntary compliance date will change
The TGA has been working towards supporting sponsors to voluntarily comply with the Unique Device Identification requirements from 1 July 2023.
Due to the number of government Bills and Budget measures being drafted, the UDI regulations will not be in place by July 2023, therefore the voluntary compliance date will be deferred.
The UDI team will provide updated advice on revised timeframes for voluntary and mandatory compliance dates when known.
Consultation status
Submissions and feedback from the third UDI consultation paper are now available. Read responses to the Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework. Information about UDI timelines will be available here on the UDI hub when they are confirmed.
Final guidance and relevant regulatory changes will be published here on our website, following approvals by the Government.
Australian Unique Device Identification database (AusUDID)
The next iteration of the AusUDID is the AusUDID Pre-Production which is planned for release in April 2023.
The production version of the AusUDID is planned to go-live to support voluntary submission of UDI data from 1 July 2023. This date depends on the date the regulatory framework takes effect.
Two users registered in the AusUDID Sandpit as health professionals. A number of hospitals are participating in early adopter projects.
Basic UDI-DI is not required
The Australian UDI system will not require a Basic UDI-DI. Basic UDI-DI is a data element that is specific to Europe for submissions to the EUDAMED database.
UDI in hospitals and hospital software products
The TGA is working with the Commission on Safety and Quality in Health Care on this issue. We are communicating the progress of the regulatory timelines for UDI to hospital sectors and the Medical Software Industry Association. Healthcare professionals should discuss and then develop their own internal processes for:
- the implementation or adoption of UDI in hospitals and healthcare organisations
- the software products used in a healthcare organisation.
Tracking adverse events
UDI will support adverse event tracking. We will require the UDI to be included in adverse event reports and recall notices.
UDI requirements for specific situations
Information on the UDI requirements for specific device types and scenarios will be provided in the UDI guidance documentation. This will be published following the regulatory requirements being agreed by the Government.
Our guidance will include information on issues like:
- patient matched, 3D printed, and patient specific devices being used
- reprocessed devices like orthopaedic screws and plates
- inputting data when multiple sponsors exist for the same device.