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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
    Medical Device Establishment Licence (MDEL) application: instructions (FRM-0292) In light of COVID-19, please only email any completed MDEL application forms, amendments and/or notifications to the MDEL application email account at: [email protected]. We are unable to process … 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
    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 …

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 …

Guidance on Medical Device Establishment …

    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 …

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
    How much will the Medical Device Establishment Licence (MDEL) fee go up every year? 42. What if my licence was issued prior to April 1, 2020, and I am currently on …

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 …

Licences - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/licences.html
    Licences - Canada.ca Licences Establishment Licence Listings Medical Devices Licence Listings Medical Devices Active Licence Listing (MDALL) Purchase of …

Health Canada on Medical Device …

    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 …



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