Marketing Authorization Holder (MAH) for Medical Devices and Pharmaceuticals/Drugs in Japan

In 2005, Japan replaced the previous In-Country Caretaker (ICC) system with the new, more complicated Marketing Authorization Holder (MAH) system under the new Pharmaceutical Affairs Law (PAL). Only local entities in Japan qualified as MAHs may import and sell medical products onto the Japanese market.

The MAH system is significantly stricter than the previous ICC system. The system was implemented to ensure that all imported medical products have a local company in Japan that can take full regulatory responsibility for the imported medical products.

To qualify as an MAH, an entity must be able to handle the functions of quality assurance and post-marketing safety management for its medical products. Generally, the local MAH must hire 1-3 qualified full-time regulatory employees, depending on the medical product's risk classification. The three main roles of an MAH include a General Manager, a Safety Manager, and a Quality Manager. An MAH may be a foreign firm's distributor, its own local Japanese branch or subsidiary, or an independent third party contracted to fill the role. In the last case, it is called a Designated Marketing Authorization Holder, or D-MAH.

PBM can act as your D-MAH in Japan. Appointing an independent third party as your MAH as opposed to a distributor allows for more marketing flexibility and increased control. In this situation, product registrations/licenses can be under the manufacturer's name instead of the distributor's name.

For more information on the MAH system in Japan, please see the following PBM publications and/or contact us to discuss your specific needs.

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