Surgical Mesh Reclassification Update January 2022
The TGA reminds USANZ Members that 1 December 2021 was the deadline requiring all surgical mesh devices to be up-classified to high risk (Class III) devices.
For continued supply, sponsors were required to either:
- Submit an application for a Class III TGA conformity assessment before 1 December 2021; or
- Submit a Class III application for inclusion in the ARTG before 1 December 2021.
The TGA had previously communicated a list of surgical mesh devices (non-urogynaecological) that have met the above requirements and can continue to be supplied from 1 December 2021.
For some of these models, the Class III application for inclusion in the ARTG has been withdrawn. As a result, these models are no longer eligible for the transition arrangement and cannot be supplied under their current Class IIb ARTG entry. The models are:
Sponsor: Medical Specialties Australasia Pty Ltd
Product range: Mesh, surgical
- TiLENE Guard Set
- TiLENE Guard
- TiLENE Inguinal
- TiLENE Strip
These models will be excluded from the list of available devices published on the TGA website.