The TGA has recently undertaken a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG) and identified common areas of non-compliance against claimed standards in this review process. Basing on the same, the TGA has devised a guidance intending to assist manufacturers in choosing the appropriate standards and to set out expectations for performance testing of respirators, surgical respirators and medical/surgical facemasks, before inclusion in the ARTG.
Medical Face Masks and Particulate Respirators - Decode SFDA’s Requirements and Recognized Standards
As it is well known, Medical masks to be launched in the Kingdom of Saudi Arabia (KSA), must obtain Medical Devices Marketing Authorization (MDMA). In reference to the same, the Saudi Food and Drug Authority(SFDA) has recently released a guidance to specify and clarify the requirements and recognized standards to streamline products’ market-entry.
The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply feasibility.