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Andrew Durfor
MFP Year
2014-2015
MFP Class
19
Home Agencies
U.S. Department of Health and Human Services, U.S. Food and Drug Administration
Host Agencies
Pharmaceuticals and Medical Devices Agency, Ministry of Health, Labour and Welfare
Objective
Gain insight into the pressures and priorities that influence medical device regulation in Japan; with attention to the risk management elements used for foreign manufacturers. Additionally, increase mutual understanding of the inspection paradigm for determining compliance with applicable GMP/Quality System requirements in the United States and Japan with the goal of increasing cooperation and mutually satisfactory outcomes.