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Reclassification of surgical mesh medical devices
The Australian Government has strengthened the assessment of surgical mesh devices as part of the broader regulatory reform agenda set by the Review of Medicines and Medical Devices Regulation.
From 1 December 2018, all new applications for surgical mesh devices (including urogynaecological mesh devices) seeking approval from the TGA will need to meet the higher evidentiary requirements of a Class III medical device.
A transition period will apply for surgical mesh devices included in the Australian Register of Therapeutic Goods because of an application made before 1 December 2018 (whether the inclusion day for the entry occurred before, on or after 1 December 2018). Further details (including critical dates) can be found in the new guidance:
- For urogynaecological mesh devices, a two year transition period applies. This means sponsors will need to lodge a re-classification application by no later than 1 December 2020.
- For any other type of surgical mesh, a three year transition period applies. This means sponsors will need to lodge a re-classification application by no later than December 2021.
Guidance for industry
In consultation with the medical device industry, the TGA has developed guidance to assist sponsors of surgical mesh medical devices who wish to continue supplying their products in Australia while meeting the new requirements:
For general information about the Class III medical device application process, you can contact the Medical Devices Information Unit on 1800 141 144, or by email at email@example.com.