Korea To Shorten Approval Times Of Innovative Medical Devices

Following quicker approval times for biopharmaceuticals in Korea, the Ministry of Food and Drug Safety (MFDS) will review and plan to expedite registration for innovative medical devices. Various government departments and medical institutions will determine within 30 days if the device meets the criteria to be designated as an innovative medical device. If it does, review times will be reduced from 250 to 80 days. Medical devices utilizing AI and new digital technologies will be included in the innovative medical device category. Devices designated as innovative will also be reviewed by the Health Insurance and Assessment Service (HIRA) for reimbursement more quickly.

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.