Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the risk-based classification system for in vitro diagnostic devices (IVDDs). The document is intended to provide medical device...
Health Canada, a Canadian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to inspections of medical device establishments. The current version of the document was published in November 2016 and replaced the...
Health Canada, the country’s authority responsible for medical devices regulation, has published guidance describing the risk-based classification system to be applied for medical devices that are not in vitro diagnostic ones (non-IVDDs). The aspects related to 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...
Health Canada, the country’s regulating authority in the sphere of medical devices, has published guidelines on special framework for importation and sale of medical device devices intended to be used in the context of the Coronavirus Disease 2019 (COVID-19) caused by...