AI-based Medical Devices and Regulations in South Korea
The technological advancement is now an integral part of healthcare and Artificial Intelligence (AI) algorithms, along with other AI-powered applications supporting medical professionals in clinical settings. AI and Machine Learning (ML)-based Software as a Medical Device (SaMD) aid medical practitioners in decision-making for better patient care. South Korea’s Ministry of Food and Drug Safety (MFDS) has guidelines to regulate and monitor the use of AI and Big Data based medical devices.