The Saudi Food & Drug Authority (SFDA), the country’s agency responsible for regulations in the sphere of medical devices, has published a second version of its guidance on approval requirements for medical device advertising. The current version of the document...
The Food and Drug Administration (FDA or the Agency), the US regulating authority responsible for healthcare products, has published a guidance document dedicated to off-the-shelf software use in medical devices. The latest version of the document was issued in...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper dedicated to the proposed refinements to the regulation of personalized medical devices. Table of Contents...
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...
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...