Korea’s MFDS Looks to Improve Regulatory Hurdles for New Digital Products

Korea has been at the forefront of the development of healthcare AI and digital products. Accordingly, the Korean MFDS tried to incorporate regulation changes to accommodate these new and innovative technologies. Today, in Korea’s National Assembly, three important regulatory reforms are being debated.

First, with respect to medical products and new IT features, there is a proposal to divide them into 3 categories including digital convergence drugs, digital health buttressing devices (fitness), and digital medical devices. Secondly, an exclusion for clinical trials that are unlikely to affect the patient’s safety. Third, the introduction of e-labels for some drugs. Basically, QR codes would be used on some drug packaging that would bring forth information on the drug efficacy, safety dosage, etc. The QR code will connect to the drug manufacturer’s website so the patients can easily obtain updated information.

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.