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Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
    Medical devices. The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Additional …

Medical device licensing - Canada.ca

    https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/licence-authorization-registration-forms-drug-health-products/medical-device-licensing.html
    Medical device licensing. Access forms and guidance documents to help you apply for a medical device licence. Also search for a licensed device using the …

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
    For more information about the import requirements of medical devices, contact Border Centres of Health Canada: Toll free (Canada and USA): 1-833-622-0414. From outside …

Approved in 2020: Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/drug-medical-device-highlights-2020/approved-2020-medical-devices.html
    The medical devices listed have been divided into categories according to the Global Medical Device Nomenclature system for naming and grouping medical devices. We …

Medical Devices Regulations ( SOR /98-282) - laws …

    https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/
    43.1 - Obligation to Submit Certificate. 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. 43.2 - Medical Devices to Be Sold for the Purposes of …

Health Canada Approval Process for Medical Devices: …

    https://www.joharidigital.com/medical-device-registration-in-canada/
    1. Investigational testing of Medical devices. The process of investigational testing involves evaluating the unlicensed devices for new uses or in new populations. …



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