TGA Update on the Reclassification of Urogynaecological Mesh
The Therapeutic Goods Administration (TGA) has issued the following information in relation to the supply of urogynaecological mesh devices following up-classification on 1 December 2020.
In Australia, all urogynaecological mesh devices will be up-classified on the Australian Register of Therapeutic Goods (ARTG) from Class IIb to Class III on 1 December 2020.
Sponsors who have an existing ARTG entry for an urogynaecological mesh device need to complete two actions:
- 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 2020.
From 1 December 2020, the TGA will commence cancelling urogynaecological mesh devices in the ARTG as Class IIb entries who have not completed the 2 actions above. The cancellation of these devices is expected to take effect from mid-January 2021.
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 2020 and mid January 2021 (when a cancellation takes effect) the supply of Class IIb devices by a manufacturer or sponsor may be unlawful.
Sponsors may request payment for Class IIb devices on order before 1 December 2020 so that supply (by the sponsor) is taken to have occurred (even if delivery is not expected by that date).
It is unlikely that all assessment and approval processes will be completed and new ARTG entries in place for all devices by 1 December 2020.
The TGA website will be updated with additional information to assist and encourage sponsors to work with healthcare facilities to ensure uninterrupted supply of Class IIb urogynaecological mesh devices, as appropriate.