South Korea has long stood at the forefront of technological advancement in Asia, with a robust healthcare system and a rapidly growing digital health ecosystem. In line with its reputation as a global innovator, South Korea has recently introduced several major regulatory reforms in the medical device sector. These changes, implemented or announced between late 2023 and early 2025, reflect the government’s intention to promote innovation, facilitate faster market access, and ensure the safety and effectiveness of new technologies.
Led by the Ministry of Food and Drug Safety (MFDS) and supported by other agencies such as the Health Insurance Review and Assessment Agency (HIRA) and the Ministry of Health and Welfare, these regulatory developments span areas including artificial intelligence (AI), generative AI, cybersecurity, usability documentation, and manufacturing quality systems.
Clinical Trial Reform for AI Medical Devices
In February 2024, the MFDS announced a significant relaxation of its clinical trial requirements for medical devices that incorporate artificial intelligence. Under the updated policy, AI medical devices that are considered low-risk can now be registered without undergoing a local clinical trial. Additionally, for higher-risk AI devices that still require clinical trials, the MFDS has removed the restriction that trials must take place only at MFDS-approved institutions. Developers can now conduct studies at other clinical sites, potentially accelerating the development process and broadening the scope of research opportunities.
This reform marks a departure from previous regulations, where all AI-based devices were subject to clinical trials conducted exclusively at certified Korean institutions. By lowering these barriers, the MFDS is aiming to facilitate broader use of AI technologies in diagnosis and treatment, helping to integrate them more quickly into everyday clinical practice. The shift is especially important in Korea, which has a high rate of digital connectivity and a healthcare infrastructure well-suited to digital health innovation.
Expedited Market Entry for Innovative Devices
Another major policy introduced in November 2024 is the “Immediate Market Entry Medical Technology System,” which is designed to reduce the time to market for highly innovative medical devices in Korea. Previously, the registration process for such technologies could take up to 490 days. Under the new system, approval can now be granted within 80 to 140 days following clinical evaluation.
Devices eligible for this pathway include medical robots, digital therapeutics, and AI diagnostic tools. Clinical evaluation under this system is flexible and can include a wide range of supporting evidence, such as clinical data, prior market experience in advanced countries, international scientific publications, and reports from physicians.
Crucially, once the clinical evaluation begins, HIRA will simultaneously start its review process for reimbursement. This dual-track review is expected to reduce the overall time for patient access and lower the administrative burden on manufacturers.
To ensure patient safety, products entering the market through this fast-track pathway will undergo a three-year period of post-market surveillance. After this period, devices that demonstrate clear clinical benefits may be eligible for enhanced reimbursement rates. The MFDS has also committed to offering consultation services to help developers determine whether their products qualify as “innovative” under the new program.
In tandem with this initiative, the Ministry of Health and Welfare has announced the creation of a Digital Health Promotion Agency. This new body will lead efforts to integrate digital technologies into Korea’s healthcare system, oversee related research and development, and support the safe deployment of new solutions.
Guidelines for Generative AI Devices
In January 2025, the MFDS revealed plans to develop and publish the world’s first guideline for the registration, review, and approval of medical devices that use generative artificial intelligence. This emerging category includes devices that can generate new content or data—such as images, predictions, or treatment suggestions—based on deep learning models.
To develop the registration guideline, the MFDS has formed a task force made up of experts from academia, healthcare institutions, and the medical device industry. The group will examine international regulatory trends, assess risk factors, and define specific evaluation criteria for generative AI applications.
This initiative reflects Korea’s proactive stance on regulating cutting-edge technologies. As generative AI models become more prominent in diagnostics, clinical support, and patient engagement, establishing a clear regulatory framework will be essential to manage their safe and effective use.
Cybersecurity Standards for Digital Medical Devices
Alongside the generative AI guidelines, the MFDS has issued the “Digital Medical Device Electronic Intrusion Security Guidelines,” another forward-thinking policy aimed at protecting digital health tools from cybersecurity threats. Published in January 2025, these guidelines establish comprehensive requirements for security throughout the product life cycle.
Key elements of the guidelines include data encryption, secure communication protocols, user access controls, real-time vulnerability assessments, and continuous monitoring. They also outline responsibilities for risk management and define procedures for responding to cyberattacks.
With these guidelines, South Korea joins other major markets, such as the United States and the European Union, in setting clear cybersecurity expectations for medical device manufacturers. The goal is to protect patient safety in an increasingly interconnected healthcare environment while aligning Korean regulatory requirements with international best practices.
New Usability Documentation Requirements
Another important update in January 2025 was the MFDS’s announcement of new requirements for usability documentation in stand-alone digital medical device software. Usability is a critical aspect of software safety, especially when devices are used directly by healthcare providers or patients.
Although the full details are still being finalized, the MFDS is expected to require manufacturers to demonstrate that their software products have been designed with user-centered principles. This includes ensuring intuitive interfaces, minimizing the risk of user error, and documenting usability testing results.
These requirements bring Korea in line with global human factors engineering standards and underscore the growing importance of user experience in the regulatory review process for digital health technologies.
Harmonizing GMP with MDSAP
In March 2025, the MFDS announced proposed amendments to the Standards for Medical Device Manufacturing and Quality Management. These amendments aim to streamline the compliance process for device manufacturers by allowing for a combined application for Korea’s domestic Good Manufacturing Practice (GMP) certification and the Medical Device Single Audit Program (MDSAP).
MDSAP is a globally recognized program that allows manufacturers to meet quality system requirements across multiple countries with a single audit. By aligning its domestic GMP process with MDSAP, South Korea is reducing regulatory duplication and easing the burden on companies, particularly those involved in international trade.
In addition, the MFDS plans to delegate GMP assessments for Class 3 medical devices to specialized third-party review organizations. This change is expected to free up MFDS resources and speed up the approval process, especially for moderate-risk devices.
The above proposed changes are currently open for public comment, and industry feedback has generally been positive, citing the potential for faster approvals and improved harmonization with global regulatory systems.
Implications and Outlook
These recent reforms signal a major transformation in how South Korea approaches medical device registration. The focus is shifting from rigid, one-size-fits-all requirements to a more adaptive, risk-based framework that encourages innovation while maintaining high safety standards.
For medical device manufacturers, these changes create a more predictable and innovation-friendly environment. International companies will find it easier to enter the Korean market thanks to streamlined processes and global regulatory alignment.
For patients and healthcare providers, these reforms in Korea promise earlier access to advanced technologies, better data security, and more user-friendly tools—particularly in diagnostics, chronic disease management, and home health monitoring.
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.