Cracking the Code: South Korea's MFDS for FDA-Approved Devices

This episode explores the process for medical device manufacturers to enter the South Korean market after receiving FDA approval. We delve into the specifics of the Ministry of Food and Drug Safety (MFDS) requirements, comparing its risk-based classification and submission pathways to the U.S. system. The discussion focuses on the practical steps for leveraging existing FDA testing data, the critical need for Korea Good Manufacturing Practice (KGMP) certification, and the role of a local Korea License Holder (KLH). Key Questions: • How does South Korea's four-class risk system for medical devices compare to the FDA's? • Can performance and clinical data from an FDA submission be used for MFDS approval? • What are the three distinct regulatory submission pathways in South Korea? • Is an ISO 13485 certificate sufficient for quality system compliance in Korea? • What is a Korea Good Manufacturing Practice (KGMP) certificate and why is it essential? • What is a Summary Technical Documentation (STED) file and when is it required? • Do foreign companies need a local representative to register devices in South Korea? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.