TGA Guidance on medical/surgical face masks and respirator standards

The Therapeutic Goods Administration (TGA) is currently undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG).

The TGA has advised that they aware that there are many different standards available to manufacturers and has identified common areas of non-compliance against claimed standards throughout its review process.

A guidance is available on the TGA website to assist manufacturers in choosing appropriate standards and to set out the TGA’s expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion on the ARTG.

Visit the TGA Website here for more information