Korea Will Utilize Real World Evidence (RWE) to Expedite Digital Medical Device Approvals

Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices that utilize digital technology like AI, Big Data, and some software applications. The MFDS also said that it may require consultations with applicants to confirm the use of RWE prior to device approval.

The MFDS also points out that RWE must be reliable, and the data must be of high quality. To ensure this, the FDS says that the people gathering and examining the data must be qualified to do so. The RWE selection and exclusion criteria must be systematic. Finally, results from RWE must be double-checked and clearly explainable before it can be used.


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://globalforum.diaglobal.org/issue/june-2022/real-world-evidence-regulatory-landscape-in-asia-pacific-australia-china-japan-south-korea-and-taiwan/