FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Health Canada Issues Guidance on Device Cybersecurity

Dec. 13, 2018

Health Canada released guidance for devicemakers on how to comply with premarket cybersecurity requirements.

The agency noted the draft guidance reflects international moves to protect the healthcare sector from cyberattacks as increasing global interconnectedness and data exchange can leave devices particularly vulnerable. 

“Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses,” the agency said. The guidance offers advice on practices, responses and mitigation measures that can improve device cybersecurity.

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