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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
    Guide to Recall of Medical Devices (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) ARCHIVED - How to Submit a Trade Complaint; ARCHIVED - Medical Device Problem Reporting by Health Care …

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
    Medical devices recall guide (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) Guidance on Risk Classification of …

Problem Reporting - Canada.ca

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting.html
    Medical device initial recall reporting form (FRM-0360) Medical device final recall reporting form (FRM-0360) Guide to Recalls of Medical Devices (GUI-0054) Guidance on …

GUI-0054 | Guide to Recall of Medical Devices | Document …

    https://www.document-center.com/standards/show/GUI-0054
    GUI-0054 - 2016 EDITION - CURRENT How to Order Standards We Provide Updating, Reporting, Audits Copyright Compliance Guide to Recall of Medical Devices This …

Health Products and Food Branch Inspectorate

    https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/prob-report-rapport/gui-0065_md-im_problem_doc-eng.pdf
    Guidance on Investigation of Reported Medical Device Problems (GUI-0054) / March 25, 2011 Page 5 of 33 Control number: a unique series of letters, numbers or symbols, or …

HC-GUI-0054 | Health Products and Food Branch Inspectorate, …

    https://www.document-center.com/standards/show/HC-GUI-0054
    HC-GUI-0054 - 2016 EDITION - CURRENT Show Complete Document History How to Order Standards We Provide Updating, Reporting, Audits Copyright Compliance Health …

Medical Device Recall Reporting Form - Initial

    https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/compli-conform/prob-report-rapport/frm_0360_medical_device_initial_recall_reporting-eng.pdf
    Purpose: To capture the information manufacturers and importers are required to report to Health Canada on or before undertaking a recall, as per S. 64 of the Medical Devices …

Guide To Recall Of Medical Devices Gui 0054 | Day of Difference

    https://dayofdifference.org.au/g-medical/guide-to-recall-of-medical-devices-gui-0054.html
    Guide to Recalls of Medical Devices (GUI-0054) Guidance on Investigation of Reported Medical Device Problems (GUI-0065) Mandatory Problem Reporting for Medical …

How Health Canada inspects medical device …

    https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html
    Replaces: GUI-0064v5, How Health Canada inspects medical devices establishments, November 17, 2016. Disclaimer: This document does not constitute …

Medical Devices Compliance Program – Health Canada

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



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