Regulation Impact Statement for Unique Device Identification System for medical devices

On 6 October, as part of the 2020-2021 Budget, the Australian Government announced it will establish a Unique Device Identification (UDI) database for medical devices.

The UDI database will be administered by the Therapeutic Goods Administration (TGA) and the information can be used to support tracking and tracing of medical devices to enable timely clinical and regulatory actions if medical device safety issues are identified.

Consistent with the Government's Regulation Impact Statement (RIS) requirements, the Department of Health has certified that the Review of Medicines and Medical Devices Regulations (MMDR) undertook a process and analysis similar to a RIS. The OBPR assessed that the analysis in the independent review is sufficiently related to the UDI proposal.

The Department has estimated that there will be no increase in regulatory burden associated with the implementation of this measure.

The certification letter has been posted on the central online RIS register maintained by the Office of Best Practice Regulation (OBPR) at Unique device identification system for medical devices. Further information on Independent Reviews, RIS-like Processes and the Regulation Impact Statement Requirements can be found on the OBPR website.