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Guide to Recall of Medical Devices (GUI-0054) - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-devices-recall-guide-0054.html
    Use the Medical Device Recall Reporting Form - Initial (FRM-0360) to complete your initial recall report. Submit a section 65 final report to your nearest Health Canada regional office as soon as possible after completing the recall. Use the Medical …

Incident reporting for medical devices: Guidance …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html
    A correction can also be a recall to address nonconforming devices in distribution. Note: A nonconformity may include a problem or malfunction with the device Corrective Action …

Recalls - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls.html
    ARCHIVED - Product Recall Procedures; Summary of Drug and natural health products recall guide; Compliance and Enforcement RSS Feeds; What’s new: …

Recall policy for health products - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/recall-policy-0016/policy.html

    Health Canada Guidance on Recalls: …

      https://www.regdesk.co/health-canada-guidance-on-recalls-basics/
      Jul 22, 2021. Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to medical device recalls. The …

    PRODUCT RECALL PROCEDURES TABLE OF …

      https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/recall_proc-marche_retrait-eng.pdf
      The Health Protection Branch will provide scientific, technical and operationaladvice to the recalling firm in the development of the recall strategy as well as evaluate …

    Mandatory Medical Device Problem Reporting Form for …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-medical-device-problem-reporting-form-industry-adverse-reaction-reporting.html
      Corrective actions taken as a result of the investigation: Includes information on actions taken to correct the problem, including any postmarket surveillance, recalls, or corrective …

    Drug and natural health products recall …

      https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls/guidance-drug-natural-health-products/document.html
      If consignees do not respond to the initial notification, you must follow up. “Non-responders” are people from whom you do not receive a return fax, e-mail, courier or phone message. Health …

    Health Canada Guidance on Recalls: Notification and …

      https://www.regdesk.co/health-canada-guidance-on-recalls-notification-and-corrections/
      During the first two stages of a recall process, the party responsible for a medical device (e.g., medical device manufacturer) identifies the need in recall and …

    ARCHIVED - Product Recall Procedures - Canada.ca

      https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/recalls/product-recall-procedures.html
      The recalling firm is given every opportunity to contribute to the information on which the health hazard evaluation is made by the Health Protection Branch who, on the basis of …



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