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.
With the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively. Accordingly, Singapore’s Health Sciences Authority (HSA) has issued guidance on facilitating access to safe and effective medical devices, intended for decontaminating used respirators through provisional authorization pathway.