BSI’s Understanding the Japanese medical device market and Pharmaceutical Affairs Law (PAL) provides participants with the vital information they need to open their businesses to the world's second-largest medical market. This course 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. Participants will gain an understanding of the requirements for obtaining approval to sell medical devices in Japan, information on classification of their devices, and an understanding of quality management system requirements under PAL.
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 receive comprehensive course manuals with reference materials.
Students should have a basic understanding of medical device manufacturing and quality management systems based on ISO 13485 before taking this course.
