Korea Medical Device Registration: Digital Healthcare Update 2024

Recently, South Korea has been making significant progress in transforming its approach to healthcare, specifically through the integration of AI and digital technologies in medical devices. The Ministry of Food and Drug Safety (MFDS) is at the forefront of these efforts and paves the way for a potentially transformative period for the Korean healthcare system.

Real World Evidence Used in Approvals

On July 10, 2023, the MFDS made an announcement that could change the speed at which new medical devices reach the market. By allowing Real World Evidence (RWE) as valid clinical data for the registration of digital medical devices, South Korea is cutting through previous red tape. This is not only about speeding things up, but it is also about utilizing high-quality, real-world data to ensure that new technologies are both effective and safe. The careful scrutiny of this data ensures that it is compliant and reflects a meticulous approach to innovation.

US-Korea Cooperation

The collaboration between the MFDS and the US FDA, solidified through a Memorandum of Cooperation signed on June 5, 2023, highlights a shared vision for harmonizing regulations on AI medical products. This cooperation is aimed at making life-saving technologies accessible at a faster rate to benefit both populations who need them most. Korea’s proactive approach in reaching out to other nations to discuss similar harmonization shows a commitment to not just being an innovator, but also a global leader in the healthcare sector.

Supporting Homegrown Innovation

Korea is not only focused on bringing in innovative global technologies but also nurturing its own products too. The recent overhaul in Korean standards for medical devices — introducing new standards and revising existing ones — reflects a determination to boost the local medical device industry. The growth in Korea’s AI healthcare sector is impressive, with projections suggesting an increase to $2.11 billion by 2030. Recent regulatory reforms, such as categorizing digital health products and simplifying clinical trial requirements, show an agile approach to device regulation that matches the pace of technological advancement. In addition, introducing e-labels for drugs, which employ QR codes, offers patients transparency and up-to-date information at their fingertips.

New Freedom for AI Medical Devices

Under the new rules announced in February 2024, AI medical devices deemed to have lower risks can now be registered without undergoing clinical trials by the MFDS. Furthermore, AI medical devices that do require local clinical trials can now use non-MFDS approved sites for these studies. This marks a significant departure from previous requirements, where all AI medical devices had to be clinically tested at MFDS-approved locations for regulatory approval. The MFDS aims to enhance the accessibility of AI medical devices for patient diagnosis in Korea. Leveraging the country’s global leadership in internet usage and its advanced health-tech infrastructure, the new regulations are set to further boost Korea’s healthcare capabilities.


Korea’s recent regulatory reforms in healthcare represent a deep commitment to promoting the intersection of healthcare and technology. As Korea continues to adapt and innovate, it sets an ambitious but still achievable benchmark for other healthcare systems to follow.

Written by: Tran Doan – Director, Pacific Bridge Medical (PBM)
Ms. Doan leads Asian regulatory and business development consulting projects for both drug and medical device companies. She graduated with a B.A., Phi Beta Kappa, in Mathematics and Economics from Franklin and Marshall College.

Source used in the article: https://www.mfds.go.kr/eng/index.do