Korea forms new regulatory guidelines for AI, big data-based medical devices
TechnologyNov 23, 2017
South Korea’s Ministry of Food and Drug Safety said Thursday it has established formal approval criteria for the new generation of medical devices leveraging artificial intelligence and big data. By clarifying for the first time what type of products can be considered AI or big data-based medical devices, rather than conventional software, the guidelines are expected to help companies build their products more efficiently and in compliance with local regulations, the ministry said. According to