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Compliance and enforcement of medical devices

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices.html
    Guidance on Medical Device Compliance and Enforcement (GUI-0073) - Canada.ca Guide to reporting medical device shortages and discontinuations (GUI-0137) …

Medical Devices Compliance Program – Health Canada

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/medical-devices-program.html
    Medical Devices Compliance Program. The Medical Devices Compliance Program (MDCP) of the Regulatory Operations and Enforcement Branch oversees post-market …

Guidance on Medical Device Compliance and …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/guidance-medical-device-compliance-enforcement-0073.html
    This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act …

Compliance and enforcement: Drug and health products

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement.html
    Food and Drugs Act Liaison Office. For industry information about COVID-19, visit our COVID-19 health product industry section. Compliance and enforcement activities are …

Medical Devices Compliance Program Bulletin - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin.html
    compliance, investigation and enforcement; reporting and mitigation of medical device shortages; Through compliance promotion activities, MDCP strives to …

Medical devices - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
    The Regulatory Operations and Enforcement Branch is responsible for managing the national compliance and enforcement program for medical devices. This …

Regulatory Operations and Enforcement Branch

    https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/regulatory-operations-enforcement-branch.html
    ROEB strives to achieve excellence in all compliance and enforcement activities. These activities may include: field inspection product sampling compliance verification …

Compliance and enforcement policy framework - Canada.ca

    https://www.canada.ca/en/health-canada/corporate/mandate/regulatory-role/what-health-canada-does-as-regulator/compliance-enforcement-framework.html
    Health Canada's compliance and enforcement actions and decisions are based on the best available evidence, information and science. Evidence is assessed objectively and is based on Health Canada's Decision Making …

Medical Device Complaint Form (FRM-0317) - Canada

    https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/health-product-complaint-form-0317.html
    If you represent a company whose device is linked to an incident and qualifies as a Mandatory Problem Report, please use Mandatory Medical Device Problem Reporting …

Guidance on Medical Device Compliance and …

    https://open.canada.ca/data/en/dataset/6096a2d3-f97e-40fa-8508-f95582de8ccc
    Guidance on Medical Device Compliance and Enforcement (GUI-0073) This document outlines the strategy and provides guidance for the medical device industry on Health …



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