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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 a drug. Management of Applications and Performance for Drug Establishment …

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 Devices Establishment Licence Listing

      https://health-products.canada.ca/mdel-leim/index-eng.jsp
      From Health Canada. A Medical Device Establishment Licence (MDEL) is a licence issued to Class I manufacturers as well as importers or distributors of all device classes …

    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
      Getting and managing your establishment licence Types of MDEL applications Applying for an MDEL How to apply When will you hear from us? Checking your application status …

    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
      Medical Device Establishment Licence (MDEL) – a licence issued to Class I manufacturers as well as importers or distributors of all device classes to permit them to import or distribute a medical device in …

    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 …

    Fees for Medical Devices - Canada.ca

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/fees.html
      Medical Device License Application Fee Form [2022-04-16] Medical devices establishment licence fees. A Medical Device Establishment Licence (MDEL) is issued …

    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 …

    Route to Licensure | Medical Council of Canada

      https://mcc.ca/about/route-to-licensure/
      Whether you are in Canada or abroad, there are several steps you can take to get started on the path to licensure: 1. Confirm that your medical degree is recognized in Canada 2. Verify the requirements for medical …

    Health Canada on Medical Device Establishment Licensing

      https://www.regdesk.co/health-canada-guidance-on-mdel-applications/
      Medical Device Establishment License Requirements The particular MDEL requirements to be applied will depend on the type of activity an entity intends to conduct. According to the document, a …



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