Reclassification of surgical mesh devices

Due to serious concerns the Australian TGA will apply as of December 1st 2018 the new classification for surgical meshes, as already announced in the regulatory amendments of October 2017.


The revised classification rule as given in Clause 3.4 will now read as follows:


Clause 3.4 - Surgically invasive medical devices intended for long-term use and implantable medical devices


(4A) The device is classified as Class III if it is:


(b) Surgical mesh