Designated Marketing Authorization Holder (DMAH) Service

Designated Marketing Authorization Holders (DMAHs) under the Foreign Special Approval System (FSAS) are required to establish a management system and implement and maintain post-marketing safety management activities based on the Ministry of Health, Labour and Welfare Ordinance No. 169 (QMS Ordinance), and the Ministry of Health, Labour and Welfare Ordinance No. 135 (GVP Ordinance).

Micren Healthcare has obtained a Type I Marketing Authorization Holder license from the Tokyo Metropolitan Government. By selecting us as an independent Designated Marketing Authorization Holder (DMAH), you can manufacture and market your products in Japan while ensuring compliance with laws and regulations such as the QMS Ordinance and the GVP Ordinance.