Cybersecurity and AI Requirements in Medical Devices in Asia

Cybersecurity and AI Requirements in Medical Devices in Asia – Whitepaper Overview

Increasing connectivity and software integration in medical devices is creating new cybersecurity challenges that directly impact patient safety and data protection. Adaptive, lifecycle-based frameworks to maintain trust, safety, and resilience amid growing digital threats in healthcare is of growing importance.

This whitepaper examines the evolving landscape of cybersecurity and AI requirements in medical devices in Asia. It reviews the regulatory frameworks and guidelines issued by key Asian jurisdictions – South Korea, Japan, Taiwan, China, Hong Kong, and Singapore – emphasizing lifecycle risk management, data security, and system robustness.

It also discusses emerging AI-specific controls and how these countries are balancing innovation with patient safety through binding laws and evolving guidance.

This Whitepaper Covers:

• National regulatory frameworks for medical device cybersecurity and AI oversight in South Korea, Japan, Taiwan, China, Hong Kong, and Singapore
• Detailed analysis of key regulations, standards, and guidance documents including legislative acts, technical standards, and certification requirements
• Cybersecurity principles including risk management, secure software development, vulnerability handling, and post-market surveillance
• AI-specific regulatory controls addressing data governance, model development, monitoring, transparency, and continuous learning in AI/ML medical devices
• Differences and commonalities in regulatory approaches across Asian countries, including binding laws versus voluntary guidance
• Emerging trends in cybersecurity labeling, best practices, and harmonization efforts within the region
• Recommendations for manufacturers on compliance, quality management, and ongoing risk assessment throughout the device lifecycle
• The impact of AI integration on regulatory expectations and patient safety considerations in medical device development and deployment

*This whitepaper was originally published on 20th August, 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

Authors

Kahyeon Seo, Regulatory Product Compliance Analyst, Compliance & Risks

Kahyeon is a Regulatory Product Compliance Analyst in the Global Regulatory Compliance Team, specializing in medical devices, cosmetics, and South Korean regulatory frameworks. 

With deep expertise in navigating complex compliance requirements, she provides critical insights to ensure product safety, market access, and adherence to evolving regulations. As a subject matter expert, Kahyeon supports global regulatory strategies and fosters alignment with international standards across healthcare and consumer product sectors.

Kahyeon holds a Bachelors in Neuroscience and Sociology of Law, Crime, and Deviance.