Medical device reforms: benchmarking against international assessment timeframes

Project overview

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, our 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.

Only Australia split conformity assessment (or equivalent) and market authorisation. This split relates to the extensive use in Australia of approvals from recognised comparable overseas regulators. Other jurisdictions us 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.

More information

• medical device inclusion process.
• conformity assessment.