FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published an information notice dedicated to Automated Endoscope Reprocessors (AERs) – medical devices used to reprocess endoscopes of various...
Canada
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published guidelines dedicated to medical device shortages and actions to be taken by parties involved in this regard. In particular, the document describes measures to be taken in...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the regulatory requirements for medical devices based on Artificial Intelligence (AI) technology. In...
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to software as in vitro diagnostic medical devices. The initial version of the document was published in September 2013....
FDA
The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the eSTAR Pilot Program, which is a part of the 510(k) Program Pilots together with the 510(k) Review...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, the regulating authority in the sphere of medical devices, has published questions & answers on clinical investigation. Please note that the document does not represent the...
