Selling Medical Devices In Canada

Guidance for exceptional importation and sale of medical …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/draft-guidance-exceptional-importation-sale-medical-devices.html

Importers, distributors and manufacturers seeking to import or sell designated medical devices in Canada must hold a valid medical device establishment licence (MDEL). How to submit an application An establishment that holds an active MDEL may ask Health …

https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/fees-respect-human-drugs-medical-devices/right-sell-licensed-class-medical-devices-funding-fees-drugs.html

Fees for the right to sell licensed Class II, III or IV medical devices Fee for the right to sell licensed Class II, III or IV medical devices as of April 1, 2023 Fee category …

Regulatory requirements for importing medical devices

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/regulatory-importing-medical-devices.html

Our Medical Devices Directorate (formerly the Medical Devices Bureau) helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. The Medical …

Frequently asked questions: Medical device …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/annual-review-documents/frequently-asked-questions-medical-device-establishment-licensing-fees.html

A Medical Device Establishment Licence (MDEL) is issued for the activities of manufacturing (class I), importing or distributing (selling) medical devices for human use in …