Supply of Surgical Mesh Devices Following Up-classification On 1 December 2021
In Australia, all surgical mesh devices will be up-classified from Class IIb to Class III on 1 December 2021.
Sponsors who have an existing entry in the Australian Register of Therapeutic Goods (ARTG) for a surgical mesh device are required to complete two actions to ensure uninterrupted supply of their mesh devices:
- Have a Class III conformity assessment certificate for the device; and
- Have applied to the TGA for a Class III ARTG inclusion for the device prior to 1 December 2021.
From 1 December 2021, mesh devices that are included as Class IIb entries that have not been subject to the above actions will need to be cancelled from the ARTG. The cancellation of these devices is expected to take effect from mid-January 2022, due to legislative timeframes for regulatory decisions. Sponsors may cancel their own entry at any time and will be encouraged to do so if they have not met the transition requirements above.
Following cancellation, practitioners:
- can continue to use existing stock on hand;
- source Class III devices that are included in the ARTG; or
- apply under the Special Access Scheme (SAS) (category B) or Authorised Prescriber (AP) schemes to import or supply cancelled Class IIb devices.
Between 1 December 2021 and mid-January 2022 (when a cancellation may take effect) the supply of Class IIb surgical mesh devices by a manufacturer or sponsor may be unlawful if the mesh device has not met the transition requirements.
Sponsors may request payment for Class IIb devices on order before 1 December 2021 so that supply (by the sponsor) is taken to have occurred (even if delivery of the devices is not expected by that date).
It is unlikely that all sponsors will proceed with up-classification, or the assessment and approval processes may not be completed by 1 December 2021 for those sponsors that are up-classifying their devices. There might be potential or actual supply disruption of these devices.
Advice has been published on the TGA website encouraging healthcare facilities to work with sponsors to ensure an uninterrupted supply of surgical mesh devices, as appropriate.
The web page will continue to be updated as surgical mesh devices are included in the ARTG as Class III medical devices or if they meet the transition requirements and can continue to be supplied as Class IIb medical devices.