The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and requests associated thereto. The document provides an overview...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the De Novo classification process and regulatory framework associated thereto. Table of Contents Due...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulating authority, has initiated a public consultation regarding the regulatory framework for medical devices. In particular, the authority encourages medical device manufacturers and other...
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the registration of medical devices. Apart from the general requirements for registration of medical devices...
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the procedures and processes associated with medical device product registration. The initial article on the matter...