Guidance Document: Pre-market Requirements for Medical Device Cybersecurity

Health Canada’s new premarket requirements on medical device cybersecurity came into effect

Health Canada’s new premarket requirements on medical device cybersecurity came into effect on 27 June 2019, following the adoption of the regulator’s final guidance document earlier this month.

The final guidance document introduces new information under certain pre- and post-market areas. Most updates address monitoring and responding to emerging risks, as well as license applications, including the Table of Contents (ToC) format. Considerations for monitoring and responding to emerging risks relate to post‐market vigilance, patching, disclosures of vulnerabilities and information sharing.

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