Medical device reforms: Benchmarking against international assessment timeframes

Project overview

The Review of Medicines and Medical Device Regulations identified that timeframes for the TGA's conformity assessment should be reviewed after benchmarking with comparable overseas regulators.

In 2019, an independent review of the TGA's conformity assessment timeframes for medical devices in relation to those for other international regulators was undertaken. While comparisons are difficult, TGA timeframes compare well internationally. Conformity assessment (or equivalent) timeframes vary between jurisdictions, and while direct comparison is difficult due to differences in regulatory approaches, the TGA timeframes are broadly in line with comparable international regulators (Europe, Canada, UK, USA, Brazil and Singapore). Therefore, no changes to statutory timeframes were made.

Australia was also the only jurisdiction examined in the report to split the conformity assessment (or equivalent) and market authorisation steps. This split relates to the extensive use in Australia of approvals from comparable overseas regulators, with other jurisdictions using fewer or no overseas approvals.

Advice has been published on medical device processing times, including the Report on TGA processes and timeframes for the regulation of medical devices and access to market: International benchmarking.

Medical device applications are subject to two statutory timeframes under the Therapeutic Goods Act 1989 (the Act). Further information including application processing timeframes can be found in the Medical Devices section of the TGA's Annual performance statistics report.

Guidance for industry

Further information is available about the medical device inclusion process  and  conformity assessment.