Guidance Document: Pre-market Requirements for Medical Device Cybersecurity

Description

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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Name Format Description Link
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity HTML 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 Cybersecurity HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/information-demandes/lignes-directrices/cybersecurite/document.html#a1.3

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