Foreign risk notification for medical devices guidance document: Background

Foreign risk notification for medical devices guidance document: Background This guidance document is to help holders of Canadian authorizations for medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN). 2024-03-30 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyForeign risk notificationmedical devicesguidance documentbackgroundauthorizations for medical-devicesregulatory requirementscomply with regulatory-requirements Foreign risk notification for medical devices guidance document: BackgroundHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/foreign-risk-notification-medical-devices-guidance.html Foreign risk notification for medical devices guidance document: BackgroundHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/rapports-publications/medeffet-canada/risques-etrangeres-orientation-instruments-medicaux.html

This guidance document is to help holders of Canadian authorizations for medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN).

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