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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
    Health Canada's Compliance and Enforcement Policy for Health Products (POL-0001) and Guidance on Medical Device Compliance and Enforcement (GUI-0073) state that the primary responsibility of a regulated party is to understand its obligations under the Food and Drugs Act and its Medical … See more

Forward Regulatory Plan 2022-2024: Modernizing the …

    https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/modernizing-medical-device-establishment-licensing-framework.html
    The Modernizing Medical Device Establishment Licensing Phase II package is targeting pre-publication of proposed amendments to the Medical Devices Regulations in Canada …

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; Application for …

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
    Guidance on Medical Device Establishment Licensing (GUI-0016) - Summary From Health Canada’s Regulatory Operations and Enforcement Branch In light of COVID-19, …

Medical Devices Licence Amendment Minor Change …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms/medical-devices-licence-amendment-back-form-guidance-manufacturer.html
    Medical Devices Licence Amendment Minor Change Form - Guidance for Changes to the Manufacturer's Name and / or Address of Existing Device Licences Only …

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 …

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
    If it is determined upon review that a device is not in fact a medical device, Health Canada will not refund the Medical Device Establishment Licence (MDEL) fee. Note: it is the applicant's …

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

    https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/
    32 - Application for a Medical Device Licence 32.1 - Quality Management System Certificate 33 - Foreign Manufacturers 34 - Application for a Medical Device Licence Amendment …



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