ABSTRACT
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. The Ministry of Health, Labour and Welfare (MHLW) covers a wide range of areas from medical care to employment and childcare support and each department of the ministry serves "for people, for life, and for the future" on a daily basis. The Pharmaceutical and Food Safety Bureau sets consistent regulations from production to sales and post-marketing safety measures based on the Pharmaceutical Affairs Act, in order to ensure the efficacy and safety of drugs, medical devices, etc. The Pharmaceuticals and Medical Devices Agency (PMDA) conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. Quality management system (QMS) inspections are conducted for medical device manufacturing facilities in Japan and in other countries based on the requirements set by the QMS Ordinance.
