As interest has grown in Korea in the rapidly developing applications of medical software to diagnose, treat, cure or prevent disease, regulators have increasingly turned their attention to digital healthcare, particularly Software as a Medical Device (SaMD) technologies.
With clinical trials of SaMD in the country up by more than 300% since 2018, and the type of SaMD products on the market skyrocketing, Korean health and safety authorities have responded by reforming regulations of the technologies. Under the reforms instituted by the new Digital Health Regulation Support Division established by the Korean Ministry of Food and Drug Safety (MFDS), the number of product categories classified by authorities will increase, and revised guidelines for the use of SaMD are underway to better regulate the labeling, advertising, downloads and installation and imports of SaMD products.
Under the new regulations, SaMD that use medical records will be exempt from review by MFDS as long as their clinical trials are approved by committees as medical institutions opting to use the technologies.
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.imdrf.org/sites/default/files/2022-09/IMDRF%20Korean%20Regulatory%20Updates_220911_FINAL.pdf