Unique Device Identification (UDI) requirements will be mandatory for high-risk medical devices from 1 July 2026 under the Therapeutic Goods (Medical Devices) Regulations 2002 (the Medical Devices Regulations).
Sponsors with medical devices that do not comply with the new UDI requirements may need to seek consent from the TGA to import and supply these devices under sections 41MA and 41MAA of the Therapeutic Goods Act 1989.
Subject to approvals, the Medical Device Regulations will be updated to allow a streamlined process for submitting and assessing UDI consent to supply (CtS) applications and a reduced fee to commence from 1 July 2026.
The UDI CtS application fee is expected to be $80 for the first Australian Register of Therapeutic Goods (ARTG) entry and $10 for each such additional entry included in the same application.
Important note
The streamlined approval process and reduced fee will not be available to sponsors who submit a UDI CtS before 1 July 2026.
To assist the transition the TGA advises:
- Sponsors are not required to submit any UDI CtS application for Class III and Class IIb medical devices before 1 July 2026; and
- The TGA does not intend to take regulatory action where sponsors apply for a UDI CtS from 1 July 2026 and import or supply the devices during the period from 1 July 2026 and when the consent is granted.
Sponsors should use the streamlined approval process and the reduced fee for the UDI CtS from 1 July 2026.
The TGA will review this position in 2 months. Sponsors who need a consent to supply are encouraged to apply in a timely manner from 1 July 2026.
Note
The TGA will publish resources specifically for UDI CtS applications, including a user guide and additional information, in the coming weeks.