As of 25 November 2014, the Japanese Pharmaceutical Affairs Law (also known as PAL) was revised, with its title changed to the “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” (abbreviated as the PMD Act). The PMD Act provides the legal framework for the regulation of medical devices, in vitro diagnostic reagents, pharmaceuticals, drugs and cosmetic products as well as regenerative and cellular therapy products in the Japanese market. Administration and oversight of the PMD Act legal framework is the responsibility of Japan’s Ministry of Health, Labour and Welfare (MHLW). Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory agency that works together with MHLW. It conducts scientific assessments of marketing application of pharmaceuticals and medical devices, monitoring their post marketing safety.
For more information about the Japanese regulation changes, please refer to our Med-Info on the “New Act on Medical Devices in Japan”.
Japan’s medical device classification system is based on Japanese Medical Device Nomenclature codes, which differ somewhat from the classification schemes used in the U.S. or the European Union. As of April 2005, third-party registered certification bodies (RCBs) are permitted to evaluate Class II devices and conduct marketing certification required to legally sell medical devices in Japan. In order to be certified, medical devices must demonstrate compliance with specified Japanese Industrial Standards (JISs), which define product safety and performance requirements. RCBs are also permitted to evaluate Class III “me-too” medical devices and provide marketing certification services as of 25 November 2014. In order to be certified, Class III “me-too” medical devices must demonstrate compliance with essential requirements, which have been harmonised to Global Harmonization Task Force (GHTF) documentation. Substantial equivalency to similar medical device(s) already legally marketed in Japan is also required.
In addition, companies must register their manufacturing sites located outside of Japan and obtain a manufacturer’s registration from the PDMA if the site performs one of the following functions:
- Design and development
- Production or sterilisation of medical devices
- Design and development or filling of in-vitro diagnostic reagents
Manufacturers based outside of Japan must also appoint a marketing authorisation holder (MAH), a company based in Japan who is the legally responsible party for certified medical devices. The MAH and registered manufacturing sites must establish and implement quality management system based on Japanese QMS ordinance. For more information about the revised J-QMS ordinance, please click here.