Understanding processing timeframes for medical device applications

The Government accepted MMDR recommendation 21 to 'establish target timeframes that reflect international benchmarks and the typical lifecycle of a medical device' for assessment and inclusion in the ARTG.

In 2019, an independent reviewer compared the TGA's processes and timeframes against international regulators, including the USA, Canada, Japan, Brazil and the European Union (using the UK and the Netherlands as examples). Overall, it was difficult to compare them due to the differences between regulatory systems. Table 1 in the report provides a summary comparison across jurisdictions.

As outlined in the report, conformity assessment (or equivalent) timeframes vary between jurisdictions, and in many jurisdictions they also vary in line with the risk of the medical device being assessed. Of the compared jurisdictions, only Australia splits the conformity assessment (or equivalent) and market authorisation steps (i.e., inclusion in the ARTG). We do this to allow the use of approvals from comparable overseas regulators, while other jurisdictions use few to no overseas approvals.

Medical device applications are already subject to two statutory timeframes under the Therapeutic Good Act 1989- external site (the Act) and further information can be found in the Medical Devices section of the TGA's Annual performance statistics report. After considering the report findings, no changes are proposed to these statutory timeframes.

All applications are assessed individually, and actual processing times can vary due to circumstances including:

• whether the application lodged is complete and includes all necessary supporting information.
• how quickly a sponsor responds to any requests for additional information.
• Whether the clinical information provided aligns with the requirements of the Australian Clinical evidence guidelines documents for medical devices.

The Australian Regulatory Guidelines for Medical Devices contains information on the inclusion process for medical devices and IVD and the conformity assessment processes for medical devices and IVDs.

Sponsors should note the requirements for each type of application and have all documentation ready when an application is submitted. This will help reduce the TGA needing to request further information from Sponsors and will help speed up the assessment process. Sponsors are also encouraged to quickly respond to requests for information to avoid delaying the application progress.

July to December 2021

The TGA processing times for conformity assessment applications and applications for inclusion on the ARTG are calculated using the TGA Half-yearly Performance Snapshot 2 July to 31 December 2021.

From October 2020, changes were made to align the inclusion process for Class I medical device applications with other medical device applications. This means that an assessment will be undertaken to ensure the requirements for inclusion have been met, and where necessary an application may be selected for audit.