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Company Profile

Company name
Japan MDC, LLC
Date of
Foundation
14th July 2003(Delaware, USA)
25th September 2003(Tokyo, Japan)
Address
2-2-6 Minami-Aoyama, Minato-ku, Tokyo, 107-0062 Japan
President&CEO
Kunihiko Mitsuda
Official
members
The member of the Swiss Chamber of Commerce and Industry in Japan (SCCIJ)
The member of the European Business Council (EBC)
The member of of the committee of the TaskForce WG7 (*1)
The member of the committee of the Educational Seminars SIG (*2)
(*1) MHLW, PMDA and industrial groups of medical devices have established nine Working Groups to achieve accelerated review duration for approvals. The WG7 is one of the 9 WGs, and where contents, system and quality of PMDA consultation system have been discussed to improve them.
(*2) Educational Seminars SIG organizes regulatory seminars for medical device industries periodically, in cooperation with MHLW, PMDA, and Task Force WGs.

Company History

Japan MDC was founded by Kunihiko Mitsuda and Nobuko Matsunaga in July 14th, 2003, focusing on marketing and regulatory consulting specialized in Medical Devices. The first office was on 30th floor of Park-tower building at Shinjuku in Tokyo.

Company Experiences

Japan MDC contributed product registration for class I-IV medical devices, including new medical devices.

  • Cerebrovascular Devices
  • Cardiovascular Devices
  • Surgical Lasers
  • Neurosurgical Devices
  • Cochlear Implants
  • Central Intravenous Catheters
  • Stents and Catheters for Cardiovascular
  • Vascular Ultrasound devices
  • Transplantation of Stem Cells
  • Stents and Catherters for Urology
  • High Intensity Focused Ultrasound (FUS, HIFU)
  • Extracorporeal Shock Wave Lithotripsy (ESWL)
  • Dental equipments
  • Dental implants
  • Light source therapeutic devices
  • Bone density measuring equipments
  • Metabolic syndrome measuring equipments
  • X-ray diagnosis equipments
  • Disposable products (catheters, stents, respiratory tubes, biopsy needles)
  • Drug delivery Medical devices
  • Acoustic Instruments
  • Implants equipments
  • Program Medical Devices
  • Reconstruction Devices

Company Qualification

The 1st Class MAH※ of Medical Device
※MAH＝Marketing Authorization Holder

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