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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 device licence will r… 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 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
    Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) In light of COVID-19, please only email any completed MDEL application forms, amendments …

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
    The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada. Class I medical devices do not require a medical device licence and …

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 …

Health Canada MDEL renewal for 2022 - AXSource

    https://regulatory.axsource.com/health-canada-mdel-renewal-for-2022/
    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 …

Health Canada Guidance on MDEL: Annual …

    https://www.regdesk.co/health-canada-guidance-on-mdel-annual-review-updating-cancellation-and-suspension/
    How Can RegDesk Help? Submitting an Annual License Review Application According to the applicable legislation, any and all holders of the medical …

Medical Device License Health Canada …

    https://qualitysmartsolutions.com/health-canada-medical-device-establishment-licence-and-class-i-ii-iii-iv-medical-device-licensing-solutions/
    A Medical Device Establishment Licence (MDEL) is an authorization granted by Health Canada to a person in order to manufacture, import, advertise or sell medical devices …



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