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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.
After product registration in Japan, a foreign medical device company's products and the classifications of those products will be the basis of the services required for a MAH or DMAH. There are several different fee schedules for ongoing DMAH services.
The new system allows foreign manufacturers to obtain marketing approval through a DMAH for their own products by pursuing the following actions and documentations:
* 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.
However, by introduction of the DMAH system, Japan has become an open market with big opportunities for middle, small and virtual companies.
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- DMA Software Measurements and Metric Analysis Handbook
- Dmanisi (paleoanthropology)
- Dmanisi Province, Ottoman Empire