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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the electronic submission template to be used for medical device 510(k) submissions.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...
Africa
The Health Sciences Authority (HSA), Singapore’s regulating agency in the sphere of healthcare products, has published a detailed guidance document describing the most important aspects associated with the registration of medical devices in order for them to be...
Canada
Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices already placed on the market. The document is intended to assist medical...
