Hyewon Roh is the Director General of Medical Device Evaluation Department at the Ministry of Food and Drug Safety in South Korea. The department is responsible for the review and approval of medical devices to assure the safety, effectiveness and quality of medical devices. She received her Ph.D in Pharmacy from Ewha Womans University in 2009. Since she started her career at the MFDS in 1997, she has held a number of positions, comprehensively involved in various tasks from scientific review and research to policy on and planning for medical device evaluation, QMS inspection, standards development, IVD regulations, GCP, innovative medical devices and others.