Quick Korean Medical Device Regulatory Updates

On January 24, the Korean MFDS made public that it would put together and publish the world’s first Guideline for Approval and Review of Medical Devices Using Generative Artificial Intelligence (AI). To this end, the MFDS has formed a special group of key experts, including people from industry, academic institutions, and the medical community. The goal will be to examine regulatory trends related to devices that use AI and outline what needs to be included in the registration evaluation process. In addition, the MFDS also outlined requirements for the “Usability Documentation” for stand-alone digital medical device software in Korea.

On January 24, the MFDS recently published the “Digital Medical Device Electronic Intrusion Security Guidelines.”  These guidelines set a global benchmark in protecting digital medical devices from cyber threats while guaranteeing patient safety through holistic security measures. The guidelines include technical and physical security, risk management throughout the life cycle of the product, and continuous vulnerability monitoring and responses. Key provisions include encryption, access controls, secure communication, and real-time risk assessment to mitigate cyberattacks. This initiative brings Korea in line with international cybersecurity efforts and complements similar regulations from the U.S. FDA and the EU MDR.


Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.