Korea MFDS Implements Medical Device Monthly Reporting Requirements
The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
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The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.
The 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.