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.

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Title (French) Lignes directrices sur la notification des risques survenus à l’étranger liés aux instruments médicaux : Surveillance, conformité et l’application de la loi
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Open Canada Date Published 2022-01-31 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["Notification des risques étrangers", "dispositifs médicaux", "document d'orientation", "surveillance", "conformité", "application", "exigences", "fabricants", "importateurs", "informations sur la sécurité des dispositifs médicaux", "fournir une notification", "un processus de surveillance"], "en": ["Foreign risk notification", "medical devices", "guidance document", "monitoring", "compliance", "enforcement", "requirements", "manufacturers", "importers", "medical-device safety information", "provide notification", "a monitoring process"]}
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