SERVICE
01
DMAH(Designated Marketing Authorization Holder)
Acting as the "official contact point" in the Japanese market, MDREX performs the functions of a Marketing Authorization Holder (MAH).
Enable product sales in Japan without establishing your own corporate entity.
Enable product sales in Japan without establishing your own corporate entity.
Business Activities
• Role as the marketing authority and legal responsible entity for foreign corporate manufacturers in Japan
• Support for notifications and administrative procedures related to manufacturing, import, sales, and distribution
• Support for manufacturer, importer, and distributor registration procedures
• Management of product registration, modification, and renewal within Japan
• Others
＃01
DMAH
Designated Marketing Authorization Holder
DMAH
Designated Marketing Authorization Holder
If a foreign medical device manufacturer, such as from Korea, does not have a business establishment in Japan to sell medical devices, it must appoint a business entity that holds a marketing authorization in Japan.
The appointed Marketing Authorization Holder is referred to as a DMAH.
＃02
Role of the DMAH
Role of the DMAH
The DMAH holds the authorization for the product and must comply with quality management (QMS) and post-marketing safety management (GVP).
