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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. Medical Devices Annual Review Documents. Application for a Manufacturer's Certificate to Cover Export of Medical …

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 …

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
    Health Canada’s guidance on Medical Device Compliance and Enforcement (GUI-0073) states that if a regulated party does not voluntarily respond to Health Canada requests, such as inspections, request for …

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
    What is the signed attestations portion of the Medical Device Establishment Licence (MDEL) application form and who is required to sign that section of the MDEL application? 16. Do I still need to hold a …

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 …

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 …

Fees for the Review of Medical Device Establishment …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-medical-device-establishment-licence.html
    Medical Device Establishment Licence Application: Form and Instructions (FRM-0292) Related acts and regulations Food and Drugs Act Medical Devices …

Health Canada on Medical Device Establishment Licensing

    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 framework for medical devices and other …



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