Guidance Document: Pre-market Requirements for Medical Device Cybersecurity

Guidance Document: Pre-market Requirements for Medical Device Cybersecurity Health Canada considers cybersecurity a component of the medical device's design and lifecycle that can affect the safety and effectiveness of the medical device. Manufacturers should consider cybersecurity when designing their medical device. 2023-11-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetymedical devicecybersecuritypre-market requirementsmedical device's designsafety-and-effectiveness of medical-device Guidance Document: Pre-market Requirements for Medical Device CybersecurityHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/cybersecurity/document.html Guidance Document: Pre-market Requirements for Medical Device CybersecurityHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/cybersecurite/document.html#a1.3

Health Canada considers cybersecurity a component of the medical device's design and lifecycle that can affect the safety and effectiveness of the medical device. Manufacturers should consider cybersecurity when designing their medical device.

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