The Australian Government has strengthened the assessment of surgical mesh devices as part of the Reforms.
From 1 December 2018, all new applications for surgical mesh devices (including urogynaecological mesh devices) seeking approval from the TGA were required to meet the higher evidentiary requirements of a Class III medical device.
Urogynaecological mesh devices, a two-year transition period applied. This means sponsors needed to lodge a reclassification application by no later than 1 December 2020.
Any other type of surgical mesh, a three-year transition period applied. This means sponsors needed to lodge a reclassification application by no later than December 2021.