Description

Medical device licence holders and importers of Class II to IV devices must notify Health Canada when there’s a serious risk of injury to human health concerning a device authorized for sale in Canada

Resources

Name	Format	Description	Link
Foreign risk notification for medical devices guidance document: Responsibilities and notifiable actions	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance/responsibilities.html
Foreign risk notification for medical devices guidance document: Responsibilities and notifiable actions	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/risques-etrangeres-orientation-instruments-medicaux/responsabilites.html

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