Canada
Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to completing the application for a new medical device license or medical device license amendment for a private label medical device....
Canada
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...
Canada
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...
Canada
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...
Canada
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...
Canada
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...
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