Health Canada Cybersecurity Draft Guidance

Health Canada issued a draft guidance document titled, “Pre-market Requirements for Medical Device Cybersecurity.” Section 1.1 states: “Health Canada considers the inclusion of cybersecurity measures an important consideration in issuing medical device licenses. Therefore, this guidance document provides medical device manufacturers advice on the practices, responses and mitigation measures which can improve the cybersecurity of their device. This guidance also outlines the information to be submitted as part of a medical device licence or licence amendment application to demonstrate that their medical device, consisting of or containing software, is sufficiently secure from intentional or unintentional unauthorized access.” Table 1 lists some design principles to consider. Table 3 lists some types of cybersecurity testing (UL 2900-2-1) to consider including source and binary code analysis using tools. Section 2.2 lists information to include in license application to Health Canada. The full draft guidance is at the link provided: 2018 HealthCanada Draft Guidance Document Pre‐market Requirements for Medical Device Cybersecurity.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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