Designated Manufacturing and Sales Services for Medical Devices (D-MAH)
We will act on behalf of overseas medical device manufacturers aiming to enter the Japanese market to handle notification and registration tasks. *We also accept temporary storage of imported devices.
■ "Third Class Medical Device Manufacturing and Sales License Number: 28B3X10031" 1. Approval (notification) to PMDA/MHLW in Japan (Foreign manufacturers can submit manufacturing and sales notifications directly) 2. Registration of foreign manufacturers 3. QMS/GVP compliance 4. Compliance with the Ministry of Health, Labour and Welfare/PMDA/prefectural authorities ■ Manufacturer Registration (Storage) "Medical Device Manufacturing Registration Number: 28BZ200196" 1. Temporary storage of imported medical devices (advanced controlled medical devices, controlled medical devices, general medical devices) 2. Use of our warehouse for packaging, labeling, and storage of your medical devices
- Company：神戸バイオ・デバイス開発研究所
- Price：Other
