Independent Review – Department of Health
On 6 October, as part of the 2020-21 Budget, the Australian Government announced it will establish a unique device identification database for medical devices.
The unique device identification database will be administered by the Therapeutic Goods Administration 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 occur.
Consistent with the Government’s Regulation Impact Statement (RIS) requirements, the Department of Health (the Department) has certified that the Review of Medicines and Medical Devices Regulation undertook a process and analysis equivalent to a RIS. The Office of Best Practice Regulation (OBPR) does not assess the quality of independent reviews used in lieu of a RIS, but does assess whether the options analysed in the independent review are relevant to the regulatory proposal. The OBPR assessed that the analysis in the independent review is sufficiently relevant to the unique device identification proposal.
The Department has estimated there will be no increase in regulatory burden associated with the implementation of this measure.