Ministery of Food and Drug Safety said on the 12th that it will certify outstanding corporations for artificial intelligence (AI) digital medical devices. Unlike traditional medical devices, digital medical devices use intangible AI or software to help treat patients.
Ministery of Food and Drug Safety will assess four competencies, including AI control measures and safety management. A certification review committee made up of experts will conduct document and on-site reviews and certify an excellent management system for suitable corporations.
If certified by Ministery of Food and Drug Safety, some documents, such as clinical trial evaluation data, may be exempted during the approval process. In this case, it is deemed to have passed the digital medical device manufacturing quality management system (GMP) conformity assessment.
Ministery of Food and Drug Safety is providing guidance containing these details through its website ((www.mfds.go.kr). Kim Myeong-ho, Ministery of Food and Drug Safety medical device safety bureau chief, said, "AI digital medical devices are advancing rapidly," adding, "We will continue regulatory support for corporations."