The Japanese Pharmaceutical Affairs Law (PAL) provides the legal framework for the regulation of medical devices, in-vitro diagnostic reagents, pharmaceuticals, drugs and cosmetic products in the Japanese market. Administration and oversight of the PAL 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.
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 issue marketing certificates required to legally sell medical devices in Japan. In order to be certified, medical device must demonstrate compliance with specified Japanese Industrial Standards (JISs), which define product safety and performance requirements.
In addition, manufacturers must implement a quality management system at each manufacturing site, which is subject to annual auditing. Companies must also register their manufacturing sites and obtain a foreign manufacturer accreditation (FMA) from the PDMA if the facility is located outside of Japan. Applications for FMAs must be submitted in Japanese. Further, manufacturers based outside of Japan must appoint a marketing authorisation holder (MAH), a company based in Japan who is the legally responsible party for certified medical devices.
TÜV SÜD Japan was the first certification body registered by Japan’s Minister of Health, Labour and Welfare, and is an RCB for all Class II medical devices and in-vitro diagnostic reagents. Currently, TÜV SÜD Japan is one of the leading RCBs in Japan, based on the number of marketing certificates issued each year, and TÜV SÜD group subsidiaries collectively have the largest number of GMP auditors on staff. These credentials, along with TÜV SÜD’s global network of medical device technical experts, provide manufacturers worldwide with an effective single source for assistance in the assessment and certification of medical devices in accordance with Japan’s requirements.
- Click here to find out how to transfer to TÜV SÜD, the Notified Body of choice