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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
    If you sell or import any class of medical devices in Canada, you must apply for and maintain a Medical Device Establishment Licence (MDEL), unless you meet exemption(s) in section 44 of the Medical Devices Regulations. You must use this form to apply for an MDEL. Use this application form to: 1. apply … See more

Medical Device Establishment Licences - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-device.html
    Medical Device Establishment Licences. Medical Devices Annual Review Documents. Application for a Manufacturer's Certificate to Cover Export of Medical …

Guidance on Medical Device Establishment Licensing …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016.html
    This document provides guidance on regulatory requirements in relation to medical device establishment licence (MDEL), such as when and how to apply for an MDEL, as well as …

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 …

Guidance on Medical Device Establishment Licensing …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-medical-device-establishment-licensing-0016/document.html
    Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in …

Establishment Licences - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html
    All Canadian drug establishments must hold, since January 1, 1998 an establishment licence to fabricate, package, label, distribute, import, wholesale, or test …

Medical Devices Active Licence Listing (MDALL)

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences/medical-devices-active-licence-listing.html
    Health Canada is the federal regulator of therapeutic products, including medical devices. We do not provide medical advice on the use of the products identified in this listing. The …

Fees for Medical Devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html
    A Medical Device Establishment Licence (MDEL) is issued for activities of importing or distributing (selling) medical devices for human use in Canada. MDELs are …

Health Canada on Medical Device Establishment Licensing

    https://www.regdesk.co/health-canada-guidance-on-mdel-applications/
    Health Canada on Medical Device Establishment Licensing May 17, 2021 Health Canada, the Canadian authority responsible for the regulatory framework for medical devices and other …



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