IMDRF 2023

Dr. Chungkeun Lee serves as a regulator (premarket reviewer) in the Ministry of Food and Drug Safety.

He has a B.S in biomedical engineering and, a M.S and a Ph.D in Electric & Electronic Engineering from Yonsei University. As a post-doctoral scholar, he worked at cardiovascular division, Yonsei University Hospital.

In November 2014, he joined the Medical Device Evaluation Department, MFDS. Since the he and has been evaluated medical electric devices with high risk classification in premarket area. In 2023, he joined the Digital Health devices division in MFDS and has been reviewing SaMD such as MLMD and DTx. He has a keen interest about real world data and evidence, and regulatory science for digital health medical devices.