UDI consultations and forums

Current consultations

UDI consent to supply consultation

In March 2025, amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 introduced UDI requirements for medical devices.

Mandatory compliance begins from 1 July 2026 for Class III and Class IIb devices, with requirements for other device classes introduced in stages over subsequent years.

We are consulting on a proposed consent to supply process for sponsors who may be unable to meet UDI requirements by the relevant compliance date. The proposal includes options for a streamlined application process and reduced fees to support ongoing supply while compliance activities are completed.

The consultation paper outlines the proposed approach, eligibility criteria and fee options.

Consultation period

• Opened: 10 December 2025
• Closes: 23 January 2026

Have your say

Scan the QR code below to access the consultation.

Review the consultation paper and provide your feedback:

UDI consent to supply consultation

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) – Introducing a UDI system in Australia
• UDI Consultation Paper 2 (2020) – Exploring implementation options
• UDI Consultation Paper 3 (2022) – Proposed regulatory framework