Japan’s new Pharmaceutical Affairs Law (PAL), implemented on April 1, 2005, outlines a shorter and less complicated application procedure for Class I medical devices. Class I medical devices are not required to have each product shonin or ninsho approved by a notified body or the Pharmaceutical and Medical Devices Agency (PMDA). However, information on the medical device such as the product name, manufacturer’s certificate number, operation manual, and guidelines for use must be reported to the PMDA.
Under the new PAL, Japan introduced the Marketing Authorization Holder (MAH) system, which requires foreign companies to designate an MAH in order to release products into the Japanese market. Foreign companies without offices in Japan that produce Class I medical devices are not required to designate an MAH at the time of application submission. However, it is essential for the importer in Japan to have a marketing license for Class I devices. The importer must apply for a marketing license at its prefecture government.
A foreign manufacturer that is exporting Class I medical devices to Japan for the first time must also obtain a foreign manufacturer certificate. The dossier file for obtaining the foreign manufacturer’s certificate must include information on the plant manager’s background, detailed descriptions of the goods to be exported to Japan, and their manufacturing process. If the packaging, labeling, and storing of the medical device will be done in Japan, the Japanese importer also needs to obtain a manufacturer license from the PMDA for labeling, packaging, and storage.
Since the implementation of the new PAL, the Japanese Ministry of Health, Labor, and Welfare (MHLW) has continued to issue new guidelines on the medical device application procedure. Japan’s regulatory system categorizes medical devices into three classes according to the risk associated with the device, with Class I being the lowest risk and Class 3 being the highest risk. It is important that foreign medical device companies that wish to enter the Japanese market are aware of the guidelines on dossier submissions for each device classification type.