Before marketing its products in Japan, a medical device manufacturer must first obtain two types of documents from the Ministry of Health, Labor and Welfare (MHLW), the kyoka (license) and the shonin (approval). A kyoka essentially grants a medical device manufacturer or a distributor permission to market its product in Japan. It is required for each manufacturing plant and representative office in Japan. The shonin is granted for each separate product once the MHLW is satisfied with the safety and efficacy of a medical device. It is required for each specific product that the medical device manufacturer markets in Japan.
When reviewing their shonin, foreign medical manufacturers must be careful to make sure that the Japanese version of the document, when translated into English, accurately describes their products and features. It is also important that foreign medical device manufacturers ensure that partial amendments to their original shonin remain current with any new versions or upgrades of their medical device. This can be done either directly from the foreign manufacturer’s office in Japan or via an In-Country-Caretaker. Sometimes what occurs is that a foreign company receives a shonin and after several years in the marketplace, their distribution continues to rely on the original approval even though the product has already undergone several upgrades. If a problem were to develop (a person is injured or dies from using the device) and the MHLW were to discover any difference between the original shonin and the upgraded devices that are currently being imported (differences in color, shape, features, etc.), this may lead the MHLW to clamp down on the foreign medical device manufacturer. In a worst-case scenario, the MHLW may even close down the foreign business.