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
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Our company provides consulting services for medical devices and related regulatory affairs, including regulatory consulting for medical devices, pharmaceuticals, and in vitro diagnostic products. With extensive experience and a proven track record, 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 STED. Additionally, we support the creation of procedures related to manufacturing and marketing under ISO 13485 and other business acquisitions based on precise advice. Please feel free to consult us if you have any requests.