FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices, has published a guidance document dedicated to the applicable classification rules. At the same time, the MDCG emphasizes that the document...
Uncategorized
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the recent changes in the regulatory framework for software-based medical devices. The new...
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has initiated a public consultation on the risk classification of standalone medical mobile applications (SaMD) and qualification of clinical decision support...
Canada
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the current classification of in vitro diagnostic medical devices (IVDDs). The document provides an...
