FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft guidance providing additional details regarding eSubmissions. The document is intended to assist medical device manufacturers...
Europe 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...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the electronic submission template to be used for medical device 510(k) submissions. The document is...
Asia The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a guidance document dedicated to the regulatory requirements for promoting and advertising medical devices. The document is intended to provide...
FDA 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 regulatory requirements for reprocessing medical devices in healthcare settings. It is important...
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...
