Designating a Japan DMAH The Ministry of Health, Labor and Welfare requires foreign medical device

Designating a Japan DMAH
The Ministry of Health, Labor and Welfare requires foreign medical device companies to appoint a Market Authorization Holder (MAH) or a Designated Marketing Authorization Holder (DMAH). A company in Japan is a MAH or DMAH if they are registered by the MHLW to provide market authorization holder services. A DMAH is the specific market authorization service provider in Japan that is used by a foreign company that does not have an office in Japan but exports their products there. A MAH or DMAH can be an (1) independent third party; (2) a distributor; or (3) the subsidiary of a foreign medical device manufacturer in Japan.

An independent third-party Japanese DMAH is the best option to control your medical device destiny in Japan, but it also happens to be one of the more costly options. The third-party entity will charge the foreign medical company a fee to register the product, in addition to monthly fees to cover
post-registration DMAH services. Some companies may prefer this route because registering the product via an independent third party will make a possible distributor switch in the future much easier. However, it is important to remember that there are currently only a few trustworthy and reliable Japanese DMAHs in the marketplace.

A foreign medical company instead may choose to use its Japanese distributor as the DMAH because this option, generally, is significantly cheaper. A Japanese distributor DMAH normally would pay for registrations costs and not charge a DMAH service fee. Nonetheless, using your distributor as your DMAH has some serious disadvantages. For example, when the distributor performs both the MAH services and distribution in Japan, an awkward situation may arise in the future, should you decide to change distributors. The Japanese distributor DMAH will not readily hand back the product license to the foreign company, especially if they predict a loss in their profitable business. In this scenario, to change distributors, a foreign device company would need to re-register its products from scratch or undertake an expensive buyout.

If the foreign medical device company has its own office or a subsidiary in Japan, that office can act as the MAH and hold registrations in the company’s name. In this case, changing Japanese distributors should be an easy process.