神戸バイオ・デバイス開発研究所 Product Lineup

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.

• Other Consulting Services
• Product Development

■ "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

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Our company provides consulting services for medical devices and related regulatory affairs, including approval application processes for medical devices, in vitro diagnostic products, and functional foods. We also assist with STED preparation, consultations with PMDA, and responses to PMDA inquiries. Additionally, we support the acquisition of business types such as manufacturing and sales, preparation of standard operating procedures, manufacturing, ISO 13485, and sales. We offer regulatory consulting for applications related to medical devices, in vitro diagnostic products, and other bioproducts, ensuring accurate and prompt responses for various PMDA pre-consultations, inquiries, and the preparation of application documents and STEDs. Furthermore, we provide support for the preparation of standard operating procedures and the acquisition of business types related to manufacturing, manufacturing and sales, and ISO 13485, based on precise advice. Please feel free to contact us if you have any requests. 【Features】 ■ 10 years of experience as a regulatory consultant ■ Consulting for over 30 companies ■ 30 years of experience and achievements in the industry ■ For those who wish to "manufacture and sell medical devices," "import and sell medical devices," or "sell functional foods." *Please download the application form as a PDF.

• Other Consulting Services
• Product Development