Holding qualifications for manufacturing and sales (D-MAH) as well as manufacturing! We handle everything from the import to distribution of overseas medical devices! We provide comprehensive support from notification to storage!
We provide support services as a Manufacturer and Marketing Authorization Holder (MAH), Designated Marketing Authorization Holder (D-MAH), and Manufacturer (Storage) for overseas medical device manufacturers.
◎ On behalf of overseas medical device manufacturers aiming to enter the Japanese market, we will handle notification and registration tasks.
1. We will apply for permits and notifications to the PMDA/Ministry of Health, Labour and Welfare on behalf of foreign manufacturers.
(Foreign manufacturers can directly submit marketing notifications as the notifier. We will assist with this.)
2. We will act on behalf of foreign manufacturers for their manufacturing registration tasks.
3. We will handle correspondence with authorities regarding QMS/GVP.
4. We will respond to the Ministry of Health, Labour and Welfare/PMDA/prefectures.
"Third-Class Medical Device Manufacturing and Sales License Number: 28B3X10031"
◎ As a manufacturing registration holder (storage), we will store your medical devices.
1. Temporary storage of imported medical devices (advanced medical devices, controlled medical devices, general medical devices)
2. Please use our warehouse for the packaging, labeling, and storage of your medical devices.
We provide comprehensive support from import to distribution. We also accept inquiries regarding pharmaceutical affairs, so please feel free to contact us if you have any questions.
*For more details, please download the PDF.