Korea MFDS Implements Medical Device Monthly Reporting Requirements June 28, 2022/in Latest Updates, South Korea/by Sarah BaikThe Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
South Korea Releases Guidance for Software using Big Data, AI, and Machine Learning September 18, 2020/in South Korea/by Sarah BaikThe South Korean regulator, the Ministry of Food and Drug Safety (MDFS), recently released multiple guidance documents related to software using AI, Big Data and Machine Learning.