Medical device and IVD registration in South Korea

South Korea is one of the most promising medical device markets in Asia. The Ministry of Food and Drug Safety (MFDS) regulatory process is well established, and demand for high-quality medical technology is robust. However, submission requirements are complex and it can be difficult to navigate the MFDS process, especially for regulatory professionals not fluent in Korean. In this free webinar, we will take a closer look at medical device registration requirements in South Korea.


• Regulatory structure in South Korea
• Overview of key medical device laws and regulations
• Medical device and IVD classification schemes
• Registration pathways, technical file requirements, and clinical data requirements
• Quality management system (KGMP) and in-country representation requirements
• And much more.


Christine Hall is the Manager, International Operations at Emergo. In this role, Christine supervises client relations and business development activities in Asia and Latin America, and spends considerable time helping clients access the Korean market in cooperation with our office in Seoul. Christine also has expertise in regulations related to Brazil, Mexico, Israel, China, and Taiwan.