UDI Consent to Supply approach and fees
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.
Give us your views
Events
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UDI Consent to Supply Information Session
From 17 Dec 2025 at 15:00 to 17 Dec 2025 at 15:55Location Teams MeetingThis 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.
Audiences
- Sponsor
Interests
- Compliance and enforcement
- Unique Device Identification (UDI)