Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a guidance document dedicated to software for use with COVID-19 rapid antigen self-tests. Apart from other aspects, the document describes...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has announced regulatory flexibilities for certain medical devices. The appropriate notice has been published on the official website of the Federal...
EU MDR/IVDR
Swissmedic, the Swiss regulating authority in the sphere of medical devices, has published an official notice describing upcoming changes in applicable regulatory requirements. The announced changes related to the procedures to be performed when placing new medical...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC), focused on further improvement of medical device regulations, has developed a guidance document dedicated to the state of the art rapid antibody tests intended for use in...
MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published the Target product profile (TPP) for the tests intended for the point of care use to detect the virus SARS-CoV-2 (the “novel...
