Sugical Mesh Classification Deadline
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).
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 website lists details of surgical mesh devices (non-urogynaecological) that have met the above requirements and can continue to be supplied from 1 December 2021.
The TGA will now progress cancellation action for those devices that have not met the requirements, which means access to cancelled devices may only occur through the Special Access Scheme.
For more information, visit the TGA website.