ABSTRACT
Japan is an island nation in East Asia, located in the Pacific Ocean with around 127 million people as of January 1, 2020, according to the Ministry of Internal Affairs and Communications. The Ministry of Health, Labour and Welfare (MHLW) designs and implements social systems and structures that are closely related to people’s lives throughout their lifetime and entire life cycle. The Pharmaceutical Safety and Environmental Health Bureau is working to ensure quality, efficacy, and safety of pharmaceuticals, etc., and to prevent the occurrence/expansion of health risks through approval reviews and safety measures of pharmaceuticals/medical devices manufactured and sold in Japan and by development of pharmacy/pharmacist systems. The Pharmaceuticals and Medical Devices Agency (PMDA) is Japanese regulatory agency, working together with the MHLW. Medical device administration in Japan is maintained in accordance with a number of laws concerned.
