A foreign medical company instead may choose to use its Japanese distributor as the DMAH because this option, generally, is significantly cheaper.
The MAH or DMAH structure is composed of three controllers.
There are several different fee schedules for ongoing DMAH services.
Application of a good manufacturing practice (quality system management) conformity audit for the applied product--for both the foreign manufacturing site and the DMAH manufacturing site (placing a Japanese label instructions for use and even temporary storage are regarded as a part of manufacturing process at the DMAH)
As a regulatory representative, the DMAH executes the above documentations on behalf of foreign manufacturer.
Outsourcing to a DMAH may be one prudent way to fulfill the requirements.