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Medical device application and report forms - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
    Application for a Medical Device Licence Amendment for a Private Label Medical Device; New Class III Medical Device Licence Application Form; …

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 - Canada.ca Canada.ca Health Drug and health products Licensing, authorizing and manufacturing drug and health products Medical …

New Class III Medical Device Licence Application Form

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/application-new-class-medical-device-licence.html

    Guidance on how to complete the …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-complete-application-new-medical-device-licence.html
      This guidance provides information to manufacturers and regulatory correspondents on how to complete an application form for a new medical device …

    Medical Device Establishment Licence (MDEL) …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/medical-device-establishment-licence-application-form-instructions-0292.html

      Application Information - Canada.ca

        https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information.html
        Application Information. In Canada, manufacturers must receive a medical device licence for certain health products defined as a "device" under the Food and …

      Application for a New Medical Device Licence for a …

        https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/application-new-medical-device-licence-private-label-medical-device.html
        Application for a Medical Device Licence Amendment for a Private Label Medical Device; New Class III Medical Device Licence Application Form; Application for a …

      Fees for Medical Devices - Canada.ca

        https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html
        Guidance Document: Management of Application for Medical Device Licenses [2019-11-08] Medical Device License Application Fee Form [2022-04-16] …

      Health Canada Guidance on Private Label …

        https://www.regdesk.co/health-canada-guidance-on-private-label-medical-devices/
        Both application forms could be accessed via the official website of the regulating authority. Duly filled application forms should be submitted to the Information …

      Health Canada Notice on Interpretation of …

        https://www.regdesk.co/health-canada-notice-on-interpretation-of-significant-changes/
        As mentioned, the present Health Canada guidance explains in detail the concept of a “significant change” in the context of requirements related to the …



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