Jul 14, 2021
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....
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Jul 8, 2021
Canada
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...
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Jul 6, 2021
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...
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Jun 23, 2021
Canada
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...
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Jun 21, 2021
Canada
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...
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