UDI Consent to Supply approach and fees

Feedback updated 11 Mar 2026

We asked

We asked for feedback on a streamlined approach with commensurate reduced fees for UDI Consent to Supply.

You said

We received 23 submissions. Most were from sponsors, with 2 from industry bodies and a small number of manufacturers.

All respondents supported the introduction of a streamlined approach for UDI only consent to supply. Most supported one of the reduced fee options, though some requested no fee or bundling the fee into annual charges.

Respondents asked that the TGA provide clear instructions on how to complete a UDI Consent to Supply application. They noted this would support submission of high-quality applications and reduce administrative burden for both industry and the TGA.

We did

Based on the consultation outcomes, we will seek Government agreement to refine the Regulations. The proposed refinements would:

  • reduce the fees associated with UDI Consent to Supply applications
  • include a refund provision for sponsors who paid the full Consent to Supply fees before Regulation changes take effect.

We will update supporting documents and UDI Guidance following a decision from the Government on the proposed refinements and to address requests raised in the consultation.

Closed 30 Jan 2026

Opened 10 Dec 2025

Contact

UDI Support Team

udi@health.gov.au

Overview

In March 2025 the Therapeutic Goods (Medical Devices) Regulations 2002 were updated to include Unique Device Identification (UDI) requirements. Mandatory compliance is set to begin on 1 July 2026 for Class III and IIb medical devices, followed by lower device classes over later years.

Compliance with UDI requirements is a significant undertaking as it impacts manufacturing processes, quality management systems, IT systems and business processes. The safety risk from non-compliance with UDI requirements for devices already in market is low and is unlikely to impact the safety or performance of these devices.

Sponsors unable to comply with UDI requirements can submit an application for Consent to import, supply, or export medical devices that do not meet the Essential Principles. Given the low risk of not being UDI compliant, TGA is considering a streamlined approval process with commensurate reduced fees to allow continued supply while organisations work to meet their UDI requirements.

The attached paper outlines the streamlined approach proposed by the TGA and options for reduced fees.

Please review these and provide your feedback for our consideration.  

 

Events

  • From 17 Dec 2025 at 15:00 to 17 Dec 2025 at 15:55
    Teams Meeting

    This information session will detail the proposed Consent to Supply process for sponsors unable to comply with UDI requirements by 1 July 2026.

    Please email us at UDI@health.gov.au for details.

    Add to my Calendar (.ics)

Audiences

  • Sponsor

Interests

  • Compliance and enforcement
  • Unique Device Identification (UDI)