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Guidance Document - Medical Device Licence Renewal …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/medical-device-licence-renewal-fees-right-sell-licensed-2019/document.html
    This guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device licence. The renewal process has two purposes: the first is to confirm whether the medical device will continue to be sold in Canada and the medical … See more

Guidance Document - Medical Device Licence Renewal …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-medical-device-licence-renewal-fees-right-sell-licensed.html
    This guidance document provides medical device manufacturers and their regulatory correspondents with the steps involved in renewing a medical device licence. …

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 …

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 …

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 …

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 …

Fees for Medical Devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html
    The Medical Device Licence Application Fees apply only to Class II, III and IV medical device licence applications. The following types of medical devices are exempt …

What MDEL holders need to know about annual licence …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2022.html
    To continue doing business, holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year …

Health Canada MDEL renewal for 2022 - AXSource

    https://regulatory.axsource.com/health-canada-mdel-renewal-for-2022/
    To maintain an active Medical Device Establishment Licence (MDEL) must apply to renew their licence before April 1 each year. The purpose of the Annual Licence Review (ALR) …

Medical Devices Active Licence Listing (MDALL) - Your …

    https://health-products.canada.ca/mdall-limh/index-eng.jsp
    From Health Canada Dear visitor, We have reorganized our Web site. Selecting the Active Licence Search link takes you to the Medical Devices Active …



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