In last month’s #WebinarWednesday, Canadian regulatory expert Ana Subramanian discussed significant changes occurring this year with Canadian medical device regulations. The two most significant changes discussed were new requirements related to foreign risk...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a detailed guidance document describing the rules to be applied when determining the class of an in vitro diagnostic medical device (IVDD). The document provides an...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...
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 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...