ABSTRACT

Japan is an island nation in East Asia, located in the Pacific Ocean, with a population of over 127 million. Regarding the international harmonization of medical device, Japan has been a founding member of the Global Harmonization Task Force and currently is a member of the International Medical Device Regulators Forum. Production, import and export values of medical devices have been 1713 (1576), 1055 (1074) and 453 (475) billion yen, respectively, in FY2010 (FY2009).1