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For some of these models, the Class III application for inclusion in the ARTG has been withdrawn.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
ARTG: 97288
Product range: Mesh, surgical
Model Names:

  • TiLENE Guard Set
  • TiLENE Guard
  • TiLENE Inguinal
  • TiLENE Strip
  • TiSURE

These models will be excluded from the list of available devices published on the TGA website.
 


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