RIKEN GENESIS supports the entry of foreign manufacturers of in vitro diagnostics (IVDs) into Japan by providing Designated Marketing Authorization Holder (DMAH) services.

Designated Marketing Authorization Holder (DMAH) Services

The revision of the Pharmaceutical Affairs Law effective April 2005 requires that a foreign manufacturer without an office in Japan and planning to market in vitro diagnostics, nonprescribed ethical drugs, proprietary drugs, or medical devices in Japan apply through "Approval System for Foreign Manufacturers". The foreign manufacturer can apply for pre-market approval, and retain the authorization, but a marketing authorization holder or DMAH based in Japan must be designated.
RIKEN GENESIS CO., LTD. has acquired"The Second-Class Drugs Marketing Authorization Holder License", which certifies RIKEN GENESIS to serve as a Marketing Authorization Holder for IVDs.
For medical devices (MDs) , "The Second-Class Medical Devices Marketing Authorization Holder License" has been acquired for serving as a Marketing Authorization Holder for MDs in Japan.
The DMAH becomes responsible for quality control based on GQP Ordinance and for conducting monitoring after sale based on the GVP Ordinance within Japan and is also responsible for carrying out various other requirements in the approval process, including product approval applications.
RIKEN GENESIS supports the entry of foreign manufacturers into Japan by providing DMAH services. We have reached agreements related to GQP and contracts related to GVP with domestic manufacturers licensed to package, label and store IVDs and with domestic distributers licensed to sell these products.

Pharmaceutical affairs support for introducing IVDs into the Japanese market

Designated Marketing Authorization Holder (DMAH) activities
Manufacturing support including packaging/labeling/storage
Support for the creation and operation of a Quality Management System (QMS)
Support for the preparation of product master file
Interpretation of regulations and notifications related to the revised Pharmaceutical Affairs Law and providing advice
Support for various pharmaceutical business-related activities
Support for foreign manufacturing site compliance with QMS Ordinances (acquiring ISO 13485 certification)

Information/Consultation Center

For information on our DMAH services feel free to contact us by telephone, fax, or e-mail.
Company Name : RIKEN GENESIS CO., LTD., DMAH Services Section
Address : 1-2-2 Osaki, Shinagawa-ku, Tokyo 141-0032 JAPAN
TEL : +81 3 5759 6041
FAX : +81 3 5759 6043


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