Understanding International Medical Device Cybersecurity Guidance

As connected medical devices become increasingly common — in hospitals, clinics, and home environments — cybersecurity expectations are expanding across global regulatory frameworks.
This whitepaper analyzes and compares four key premarket guidance documents from the U.S. FDA, Health Canada, Australia’s Therapeutic Goods Administration (TGA), and France’s ANSM, highlighting both shared principles and region-specific differences.

The analysis maps over 70 unique requirements across these jurisdictions to help medical device manufacturers (MDMs) understand how to align cybersecurity design and documentation for global market readiness.

Medical device manufacturers can no longer design for a single market.
With connected devices deployed worldwide, teams must navigate different cybersecurity expectations across regulators — balancing compliance, cost, and interoperability.
This paper helps manufacturers:

Identify overlapping requirements that can streamline multi-region submissions.

Understand where expectations diverge (e.g., firmware authentication, encryption standards, or clinician education).

Build a unified cybersecurity-by-design strategy that satisfies both FDA and international regulators.

By harmonizing global requirements early, MDMs can reduce rework, accelerate approvals, and build security into devices from concept through postmarket.

• Regulatory Affairs professionals preparing multi-market submissions
• Product managers and executives developing global market strategies
• Software and firmware engineers designing connected medical devices
• Quality and compliance teams establishing security frameworks
• Cybersecurity professionals implementing international standards
• Consultants advising device manufacturers on regulatory strategy
• Business development teams evaluating international expansion

Key Findings from International Analysis:

• 70 requirement categories identified across four regulatory guidance documents
• Universal consensus: All four countries require software patching, encryption, access control, risk management, and threat modeling
• 9 unique FDA requirements including CBOM cross-referenced with NVD and variant analysis
• 11 unique ANSM (France) requirements including failsafe mode operation and "security by obscurity" ban
• Critical difference: FDA focuses on exploitability while others emphasize probability for risk assessment
• 29 of top 36 medical device manufacturers produce connected devices sold globally
• Manufacturers cannot "design for one" market—regional variations require strategic trade-offs

Background: The International Regulatory Landscape

Section I: Data and Methods

• Comparative analysis framework
• 70 requirement categories mapped across four countries

Section II: Universal Requirements (All Four Countries)

• Software patches and updates
• Update authentication approaches
• User access and access control
• Risk management and security documentation
• Secure network communication
• Encrypt data at rest and in transit
• Measuring risk: Exploitability vs. probability
• Threat modeling requirements
• Cybersecurity testing mandates

Section III: Regional Variations

• Requirements from Canada, TGA, and ANSM
• Unique FDA requirements (9 distinct mandates)
• Unique Health Canada requirements
• Unique TGA requirements
• Unique ANSM requirements (11 distinct mandates)

Section IV: Other International Guidance

• Japan's approach
• South Korea's guidelines
• European Union MDR framework

Key Hypotheses and Strategic Implications