According to a recent announcement by Korea’s Ministry of Food and Drug Safety (MFDS), AI medical devices with reduced risks can be registered without the MFDS’ clinical trial requirement. In addition, for other AI medical devices that do require a local clinical trial, they can now be conducted at clinical locations not approved by the MFDS. This is a big change since before this new regulation, all AI medical devices needed clinical trials for MFDS approval, and such trials had to be performed at approved MFDS sites.
The goal of the MFDS is to make the use of AI medical devices more available to Korea’s patients, especially for diagnosis. Korea has always been a worldwide leader in the use of the Internet, and its highly developed health-tech architecture has been a boon to the country.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.mfds.go.kr/eng/brd/m_40/list.do