Medical devices reforms: reclassification of surgical mesh

Project overview

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.

A transition period applied for surgical mesh devices already included in the Australian Register of Therapeutic Goods (ARTG):

• 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.

Consultations

More information

• Reclassification of surgical mesh devices.
• Transvaginal (urogynaecological) surgical mesh hub.