Foreign risk notification for medical devices guidance document: Monitoring, compliance and enforcement

Foreign risk notification for medical devices guidance document: Monitoring, compliance and enforcement Requirements for manufacturers and importers for collecting medical device safety information and provide notification to Health Canada. A monitoring process should be in place to ensure compliance. 2024-03-30 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyForeign risk notificationmedical devicesguidance documentmonitoringcomplianceenforcementrequirementsmanufacturersimportersmedical-device safety informationprovide notificationa monitoring process Foreign risk notification for medical devices guidance document: Monitoring, compliance and enforcementHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/monitoring-compliance.html Foreign risk notification for medical devices guidance document: Monitoring, compliance and enforcementHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/monitoring-compliance.html

Requirements for manufacturers and importers for collecting medical device safety information and provide notification to Health Canada. A monitoring process should be in place to ensure compliance.

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