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January 14, 2026
Approximately 5 minutes
Guidance on Cybersecurity for Medical Devices – Health Canada Expectations
Guidance on Cybersecurity for Medical Devices – Health Canada Expectations
Purpose and Scope
This guidance document provides recommendations for manufacturers on addressing cybersecurity risks in medical devices throughout their lifecycle, in alignment with the Medical Devices Regulations and international standards such as IEC 81001-5-1 and IMDRF principles. It applies to all classes of connected or network-capable medical devices, including software as a medical device (SaMD), where cyber threats could affect safety, effectiveness, or data integrity. Source: Guidance on Cybersecurity for Medical Devices - Canada.ca
Key Cybersecurity Expectations
Risk Management Integration
- Incorporate cybersecurity into the overall risk management process per ISO 14971
- Identify cybersecurity threats and vulnerabilities as foreseeable hazards
- Assess exploitability, severity of impact on patients/users, and likelihood
- Implement risk controls proportionate to identified risks
Secure Design and Development
- Apply security by design principles from the outset
- Use secure coding practices and threat modeling
- Implement authentication, authorization, encryption, and secure communication protocols
- Ensure secure boot, firmware integrity checks, and secure update mechanisms
Vulnerability Management
- Establish processes for monitoring, identifying, and assessing vulnerabilities
- Maintain a Software Bill of Materials (SBOM) where feasible
- Develop and communicate coordinated vulnerability disclosure policies
- Provide timely patches and mitigations for identified vulnerabilities
Post-Market Surveillance and Incident Response
- Monitor cybersecurity information sources and threat intelligence
- Have procedures for detecting, responding to, and reporting cybersecurity incidents
- Notify Health Canada of reportable incidents per Medical Devices Regulations
- Maintain capability for ongoing secure updates throughout device lifecycle
Labelling and Documentation
- Include cybersecurity information in labelling and instructions for use
- Provide recommendations for secure configuration, network isolation, and user responsibilities
- Document cybersecurity controls and residual risks in technical files
Practical Implementation Considerations
- Adopt IMDRF and international guidance (e.g., FDA premarket cybersecurity guidance) where consistent
- Conduct regular penetration testing and security assessments
- Engage with supply chain partners to ensure component-level security
- Plan for end-of-support scenarios and legacy device risks
This guidance supports manufacturers in building cyber-resilient medical devices and aligns Canadian expectations with global best practices. Detailed recommendations, risk assessment examples, and references to supporting standards are provided in the official Health Canada cybersecurity guidance for medical devices. Source: Guidance on Cybersecurity for Medical Devices - Canada.ca
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