Unique Device Identification Consent to Supply process

Unique Device Identification (UDI) requirements became 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 UDI requirements need to seek consent from the TGA to import and supply these devices under sections 41MA and 41MAA of the Therapeutic Goods Act 1989.

The Medical Device Regulations include a reduced fee that supports a streamlined process for submitting and assessing UDI consent to supply (CtS) applications.

The UDI CtS application fee is currently $80 for the first Australian Register of Therapeutic Goods (ARTG) entry and $10 for each such additional entry included in the same application. 

For up-to-date fees please see: Summary of fees and charges to applications submitted to the TGA. 

Sponsors should use the streamlined approval process and the reduced fee for UDI CtS.