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.

  • Magnetic Resonance Guided Focused Ultrasound Systems (FUS)
  • Surgical lasers
  • Neurosurgical Devices
  • Cochlear Implants
  • Central Intravenous Catheters
  • Transplantation of Stem Cells
  • Vascular Ultrasound devices
  • Stents and Catheters for Cardiovascular
  • Stents and Catheters for Urology
  • ESWL (Extracorporeal Shock Wave Lithotripsy)
  • Dental equipment
  • Dental implants
  • Light source therapeutic devices
  • Bone density measuring equipments
  • Metabolic syndrome measuring equipments
  • Disposable products (catheters, stents, respiratory tubes, biopsy needles)
  • Drug delivery Medical devices
  • Acoustic Instruments
  • Implant equipments
  • Program Medical Devices
  • Reconstruction Devices
  • etc.

Company Qualification

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

Membership and Relationship

Japan MDC is a member of EBC (European Business Council in Japan) and SCCJ (The Swiss Chamber of Commerce and Industry in Japan).
Japan MDC is registered as a supportive organization in the Embassy of United states of America, in the Embassy of Swiss and in the Embassy of Israel.

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