Hello, this is JNPMEDI.
As digital technologies continue to converge, the functionality of medical devices is advancing rapidly—making systematic cybersecurity responses an essential requirement. In response, the Ministry of Food and Drug Safety (MFDS) enacted and published the “Security Guidelines on Electronic Infringement of Digital Medical Devices” on April 29, 2025.
These guidelines, based on Articles 14 and 32 of the Digital Medical Products Act, aim to establish both legal and technical frameworks that enable the early identification of security vulnerabilities and a prompt, coordinated response in the event of cyber intrusions.
“A Systematic Framework for Securing Digital Medical Devices”
The guidelines consist of seven chapters and 23 articles, centering on the establishment of a security management system that spans the entire lifecycle of digital medical devices. Key elements include:
- Implementation of physical and technical security measures
- Establishment of incident response protocols
- Ongoing monitoring and mitigation of security vulnerabilities
- Documentation of all security-related activities and mandatory periodic review
In addition, manufacturers are required to comply with specific technical standards such as secure communications, user authentication, file integrity verification, and encryption key management. All of these activities must be clearly documented through internal guidelines and formal reports.
For digital medical devices incorporating AI technologies, the guidelines mandate the implementation of dedicated AI security systems to prevent data manipulation and cyberattacks. This reflects the growing need for advanced cybersecurity capabilities aligned with evolving technological environments.
Moreover, the scope of the guidelines extends beyond preventive measures to include post-incident response requirements. In the event of a security breach, immediate notification must be made to the MFDS, medical institutions, and affected users. Root cause analysis and the development and sharing of recurrence prevention measures are also explicitly required by law.
“Security Responsibility Extending Beyond End-of-Service”
The guidelines clarify that security responsibilities continue even after a digital medical device has reached the end of its operational life. For legacy systems that are no longer supported, the following follow-up measures are required:
- Establishment of security patch and vulnerability response plans
- User notifications and security guidance
- Clear instructions on personal data deletion procedures
Manufacturers must also predefine the software components used in each digital medical device through a Software Bill of Materials (SBOM) and establish a tracking and response system for associated vulnerabilities. This requirement also covers open-source risk management and enhances product transparency.
To ensure the effectiveness of the guidelines, the MFDS plans to conduct a validity review and regulatory revision every three years, with the first reference point set as January 1, 2025. This approach aims to adapt to evolving technological landscapes and continuously improve the practical applicability of the guidelines.
This security guideline marks a pivotal shift in institutional policy to strengthen the safety and reliability of digital medical devices—and is expected to elevate the overall standard of cybersecurity across the digital healthcare industry.
At JNPMEDI, we remain committed to proactively responding to regulatory changes and fostering a safer, more sustainable digital medical device ecosystem.
Thank you.
📌 For inquiries: Contact Us
Hello, this is JNPMEDI.
As digital technologies continue to converge, the functionality of medical devices is advancing rapidly—making systematic cybersecurity responses an essential requirement. In response, the Ministry of Food and Drug Safety (MFDS) enacted and published the “Security Guidelines on Electronic Infringement of Digital Medical Devices” on April 29, 2025.
These guidelines, based on Articles 14 and 32 of the Digital Medical Products Act, aim to establish both legal and technical frameworks that enable the early identification of security vulnerabilities and a prompt, coordinated response in the event of cyber intrusions.
“A Systematic Framework for Securing Digital Medical Devices”
The guidelines consist of seven chapters and 23 articles, centering on the establishment of a security management system that spans the entire lifecycle of digital medical devices. Key elements include:
In addition, manufacturers are required to comply with specific technical standards such as secure communications, user authentication, file integrity verification, and encryption key management. All of these activities must be clearly documented through internal guidelines and formal reports.
For digital medical devices incorporating AI technologies, the guidelines mandate the implementation of dedicated AI security systems to prevent data manipulation and cyberattacks. This reflects the growing need for advanced cybersecurity capabilities aligned with evolving technological environments.
Moreover, the scope of the guidelines extends beyond preventive measures to include post-incident response requirements. In the event of a security breach, immediate notification must be made to the MFDS, medical institutions, and affected users. Root cause analysis and the development and sharing of recurrence prevention measures are also explicitly required by law.
“Security Responsibility Extending Beyond End-of-Service”
The guidelines clarify that security responsibilities continue even after a digital medical device has reached the end of its operational life. For legacy systems that are no longer supported, the following follow-up measures are required:
Manufacturers must also predefine the software components used in each digital medical device through a Software Bill of Materials (SBOM) and establish a tracking and response system for associated vulnerabilities. This requirement also covers open-source risk management and enhances product transparency.
To ensure the effectiveness of the guidelines, the MFDS plans to conduct a validity review and regulatory revision every three years, with the first reference point set as January 1, 2025. This approach aims to adapt to evolving technological landscapes and continuously improve the practical applicability of the guidelines.
This security guideline marks a pivotal shift in institutional policy to strengthen the safety and reliability of digital medical devices—and is expected to elevate the overall standard of cybersecurity across the digital healthcare industry.
At JNPMEDI, we remain committed to proactively responding to regulatory changes and fostering a safer, more sustainable digital medical device ecosystem.
Thank you.
📌 For inquiries: Contact Us