The article describes the regulatory changes proposed by the Canadian authority and clarifies their potential impact on the market and all the parties involved. Table of Contents Health Canada, the country’s regulating authority in the sphere of...
Health Canada, the country’s regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to inspections of medical device establishments. The document outlines the main principles of inspections to be carried...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published detailed guidance dedicated to all the aspects related to the medical device establishment license (MDEL). Apart from the regulatory procedures to be followed by an...
Health Canada, the Canadian regulating authority in the sphere of medical devices, has published a guidance document describing the most important aspects related to the medical device establishment license (MDEL), special permission necessary to carry out the...
Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other healthcare products, has published guidance dedicated to the licenses an entity shall obtain to be allowed to perform certain regulated activities. In...