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 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 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 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...