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Lili Duan

MFP Year

2022-2023

MFP Class

Home Agencies

U.S. Department of Health and Human Services, U.S. Food and Drug Administration

Host Agencies

Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Health, Labour and Welfare (MHLW), Ministry of Education, Culture, Sports, Science and Technology (MEXT), Agency for Medical Research and Development (AMED), Office of Hon. Hanako Jimi, National Diet

Objective

Gain an insider’s view of Japan's medical device review system, explore opportunities for regulation and standard harmonization, and utilize this knowledge to advance FDA regulatory policy development and international collaboration in this area upon return. Contribute to future U.S.-Japanese collaborations intended to improve patients’ access to safe, effective, and high-quality IVD medical devices in both countries.