UDI consultations and forums

Current consultations

UDI consent to supply consultation

In March 2025, the Therapeutic Goods (Medical Devices) Regulations 2002 were updated to include Unique Device Identification (UDI) requirements. 

Mandatory compliance begins 1 July 2026 for Class III and IIb devices, with lower classes phased in over later years.

To support sponsors who may not meet UDI requirements by the deadline, we are proposing a streamlined consent to supply process with reduced fees, allowing continued supply while organisations work toward compliance. 

This approach reflects the low safety risk for devices already on the market.

The consultation attachment outlines the proposed process and fee options.
Opened: 10 December 2025
Closes: 23 January 2026

Review the consultation and give us your views: UDI consent to supply consultation.

You can also access the consultation via the QR code below.

Previous consultations

A series of consultations have informed the planning and design of Unique Device Identification (UDI) implementation in Australia. Consultations have included public consultation papers, stakeholder workshops, webinars, targeted discussions and technical, regulatory and consumer working groups.

Consultation papers via the links below:

• UDI Consultation Paper 1 (2019) - Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
• UDI Consultation Paper 2 (2020) - Exploring options for the introduction of an Australian Unique Device Identification (UDI) System
• UDI Consultation Paper 3 (2022) - Detailed considerations for implementing the proposed Australian medical device UDI regulatory framework