Speakers Introduction

ByungGwan Kim is the deputy director of the Medical Device Safety Bureau of Ministry of Food and Drug Safety (MFDS), which is health authority of South Korea.

ByungGwan joined MFDS in 2011 and worked in the Medical Device Policy division for 8 years, and he then moved to the Regulatory Reform and Legal office for 4 years. Based on his extensive experiences, he returned to the Medical Device Policy division and has continued to contribute to the advancement of medical device regulation & policy in Korea.

Recently, he has been in charge of the Digital Medical Product Act in Korea, which will provide regulatory governance for digital medical products such as digital medical devices (SaMD, AI/ML-enabled medical devices), digital convergence pharmaceuticals, digital medical/health supporting products.