Korea has recently rolled out a more robust series of regulatory reforms and actions aimed at streamlining patient access to cutting-edge medical technologies over the past year. The advances signal Korea’s growing ambition to become a global leader and incubator in the digital health and advanced medical device sectors.
Market Access System Pathway for Innovative Devices
In November 2024, Korea implemented the Immediate Market Entry Medical Technology System. This system is designed to bring innovative medical devices into Korea, such as medical robots, AI-based diagnostics, and digital therapeutics. Previously, the registration approval process could take up to 490 days to complete. The new approval workflow helps eligible devices enter the market quicker – 80 to 140 days from when the clinical evaluation is completed. The clinical evaluation will take into account clinical data, international registrations, publications from experts, and real-world use in advanced healthcare markets.
Importantly, the confirmation of the clinical evaluation will trigger the Health Insurance Review & Assessment Service (HIRA – Korea’s device reimbursement agency) to start its reimbursement review process at the same time. Approved innovative devices will be kept under close observation for safety and effectiveness for 3 years. After this period, the Ministry of Food and Drug Safety (MFDS) will determine the long-term reimbursement pathway. Devices that show better efficacy than initially thought will be eligible for higher reimbursement. To further support this program, the Ministry of Health and Welfare (MOHW) has stated plans to establish a Digital Health Promotion Agency to facilitate research and development in the digital health space.
New Guidelines for Generative AI and Cybersecurity
In light of the rapid growth of artificial intelligence in healthcare, the MFDS announced in January 2025 that it would adopt the first regulatory guideline in the world for medical devices using generative AI. A group of medical device experts initiated a special working group that will evaluate overall international regulatory trends and identify what will be required for registration reviews of generative AI devices.
Meanwhile, the MFDS increased its baseline expectation of cybersecurity requirements with the release of the Digital Medical Device Electronic Intrusion Security Guidelines. These rules cover cybersecurity requirements for the entire product lifecycle: encryption, access control, secured communications, and real-time monitoring of vulnerabilities. The guidelines bring Korea in line with the U.S. FDA and EU MDR, which illustrates their commitment to safety as much as to innovation. In addition, the MFDS updated the usability documentation requirements of stand-alone digital medical device software to set clearer expectations for manufacturers of stand-alone digital health products.
Combined GMP and MDSAP Audit
In March 2025, the MFDS proposed amendments to its Standards for Medical Device Manufacturing and Quality Management that would allow manufacturers to undertake combined reviews for Korea’s domestic Good Manufacturing Practice (GMP) certification and the Medical Device Single Audit Program (MDSAP). This initiative sought to simplify the burden on device manufacturers, follow the trend of certification and audit programs in other global regulatory systems, and allow quicker access to new markets.
To take this even further, GMP assessments for Class III devices may now be conducted by specialized quality management review organizations. The MFDS has solicited public comments on the proposed changes, further exemplifying its spirit of collaboration and willingness to reform its regulatory processes.
Conclusion
These recent reforms represent a significant transformation of Korea’s medical device regulatory system. For foreign manufacturers interested in the Korean market, these changes have opened up new opportunities for earlier registration and market access while calling for closer attention to rapidly evolving standards in clinical validation, cybersecurity, and quality management.
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.