Guidance Document: Pre-market Requirements for Medical Device Cybersecurity - Summary

From Health Canada

Overview

This guidance document is intended to provide advice to manufacturers and regulatory representatives on the practices, responses and mitigation measures, which can improve the cybersecurity of their medical device.

Who this guide is for

Medical device manufacturers and regulatory representatives.

In this guide

• 1. Introduction
  • 1.1 Scope and application
  • 1.2 Policy objectives
  • 1.3 Policy statements
  • 1.4 Abbreviations and Definitions
    • 1.4.1 Abbreviations
    • 1.4.2 Definitions
• 2. Guidance for implementation
  • 2.1 Medical Device Cybersecurity Strategy
    • 2.1.1 Secure Design
    • 2.1.2 Device-Specific Risk Management
    • 2.1.3 Verification and Validation Testing
  • 2.2 Monitoring and Response to Emerging Risks
  • 2.3 Medical Device Licence Applications: Cybersecurity Requirements
    • 2.3.1 Device Label, Package Label and Documentation
    • 2.3.2 Marketing History
    • 2.3.3 Risk Assessment
    • 2.3.4 Device-Specific Quality Plan
    • 2.3.5 Safety and Effectiveness or Performance Studies
      • 2.3.5.1 Standards
      • 2.3.5.2 Cybersecurity Testing
      • 2.3.5.3 Traceability Matrix
      • 2.3.5.4 Maintenance plan
• References
• Appendices
  • Appendix A - Manufacturers' Cybersecurity Risk Management Framework
  • Appendix B - Four Diagrams Outlining the Relationship between Cybersecurity Risk Management and Safety Risk Management
  • Appendix C - Corresponding sections of Health Canada Guidance Document or Table of Contents (TOC) Folder Structure

View complete guide

Download PDF (327 KB, 24 pages)

Details and history

Published: June 17, 2019

Consulted: December, 2018 - February, 2019

Part of topic(s): Guidance documents

Contact Us

Device Licensing Services Division
Medical Devices Bureau
Therapeutic Products Directorate
Health Canada
11 Holland Avenue
Address Locator: 3002A
Ottawa, Ontario
K1A 0K9

By email: devicelicensing-homologationinstruments@hc-sc.gc.ca
By Telephone: 613-957-7285