Japan: Update on Marketing Authorization Holder Requirements Under the New PAL

As the official implementation date of the new PAL approaches (April 2005), Japan’s MHLW continues to make announcements of new medical device regulations. One of the most significant changes affecting both foreign and domestic companies selling medical devices in Japan will be the new Market Authorization (MAH) system. Once this new system goes into effect, the MAH will act as a regulatory control mechanism and grant final permission for the release of the products into the Japanese market. The MHLW devised this new system to increase the quality and safety controls of medical devices in Japan.

Any companies that are currently ICCs can go through a simple application process to officially become MAHs. According to an announcement made by the MHLW on January 17, 2005, current ICCs can submit a one-page application form by February 4, 2005 to designate them as a MAH and will not have to undergo an inspection. Those ICCs that do not plan to become a MAH should submit a letter to the MHLW stating this fact, also by February 4, 2005. Additionally, they should also try to find a replacement MAH for their current medical device customers. The MHLW will still continue to accept MAH applications after the February deadline, but the application process will be lengthier and the potential MAH will most likely be required to undergo an inspection by the MHLW or a prefectural government.

All companies selling devices in Japan will be required to have a MAH. A company has the option of using a distributor, importer, third party, or designating themselves as their MAH. A MAH should be located in Japan and can purchase or import products from a manufacturer and sell products to sales organizations. In this last case, a company can designate a subsidiary or representative office in Japan as their MAH, as long as the MAH meets the MHLW’s requirements. However, a MAH may not perform any type of manufacturing activities.

The MHLW requires that a MAH designate up to three people who will act as controllers and be responsible for overseeing the manufacturing, distribution and market release of the device. The number of controllers required for a MAH depends on the classification of the medical device the MAH is overseeing. A MAH for Class III and IV products will require three people, one designated as each controller: General Manager, Quality Assurance Controller and Post-Marketing Safety Controller. A MAH for Class II products will require two people to carry out the functions of the three controllers. For Class I products, a MAH is only required to appoint one person, who will perform the functions of all three controllers.