Medical devices reforms: Reclassification of surgical mesh

Project overview

Strengthened regulation of surgical mesh protects patient safety.

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):

• For urogynaecological mesh devices, a two year transition period applies. This means sponsors will need to lodge a reclassification 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 reclassification application by no later than December 2021.

For more information on critical dates for surgical mesh medical devices see Reclassification of surgical mesh devices.

Guidance for industry

For guidance on supplying surgical mesh medical devices in Australia while meeting the new requirements, see Reclassification of surgical mesh devices.

For more information on surgical mesh, see the Transvaginal (urogynaecological) surgical mesh hub.

Consultations

For more information see Consultations and reviews.