BSI’s Overview of Japan’s Pharmaceutical Affairs Law for medical devices provides participants with the vital information they need to open their businesses to the world's second-largest medical market. This webinar is designed specifically for manufacturers exporting medical devices to Japan and provides an understanding of recent regulatory developments, including the revised Pharmaceutical Affairs Law (PAL) of 2002, which came into force on April 1, 2005.
Note: BSI Japan is recognized by the Ministry of Health, Labor and Welfare (MHLW) in Japan under the revised PAL and, in conjunction with BSI in the USA and Canada, is beginning certification services for medical device manufacturers placing their devices into the Japanese market. With this global approach, BSI helps manufacturer’s access global markets with the minimum necessary duplication of regulatory and quality assessment. In this critical transition period, it is important to stay informed of further regulatory developments in Japan.
Students should have a basic understanding of medical device manufacturing before taking this course.
