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    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html
    The Medical Devices Regulations (Regulations) utilize a risk-based approach to regulating products within its scope. The safety and effectiveness evidence required to support a medical device …

Guidance documents – Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html
    Guidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
    The term Medical Devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis …

Draft Health Canada IMDRF table of contents for medical …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/international-medical-device-regulators-forum.html



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