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

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. …

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 …

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 …

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. …

Frequently asked questions: Medical …

    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
    How do I check the status of my Medical Device Establishment Licence (MDEL) application? 14. What is the signed attestations portion of the Medical Device Establishment Licence (MDEL) …

CANADA: MDEL renewal by April 1st, DM …

    https://www.thema-med.com/en/2021/02/22/canada-mdel-license-renewal-within-1-april-and-commissions-update-for-md/
    The Medical Device Establishment License (MDEL) is an establishment licence issued to Class I Medical Device Manufacturers and to MD Importers and Distributors of all four …



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