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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 for an … 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 - Canada.ca Medical Device Establishment Licences Medical Devices Annual Review Documents Application for a …

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
    Medical device establishment licence application: form and instructions (FRM-0292) Guidance document – Fees for the Review of Medical Device Establishment Licence …

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
    What is a medical device? The term 'medical device' covers a wide-range of …

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
    Health Canada’s guidance on Medical Device Compliance and Enforcement (GUI-0073) states that if a regulated party does not voluntarily respond to Health Canada requests, such as inspections, request for …

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 …

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 …

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 …

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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