Chief Regulatory Officer
Nobuko Matsunaga
Before founding Japan MDC with Kunihiko Mitsuda, Nobuko Matsunaga worked in the area of regulatory affairs in the medical device field. At Japan MDC, she has worked on product registration for various types of medical devices.
In addition to the daily work of regulatory consulting, she contributes to improving the regulatory environment in Japan as a member of the regulatory sub-committee of the EBC (The European Business Council in Japan).
In 2008, MHLW set up "the joint working comittee". It is composed of three major groups (MHLW, PMDA and Medical Devices Industry group). The purpose of comitee is to improve the Japanese regulatory system. She also is selected as a member of the committee .
Nobuko Matsunaga is one of the few regulatory specialists for medical devices who are trusted experts.
Publications
- “Market Report, Medical Device Market Japan 2007”
Edited & planned by the Embassy of Switzerland’s Swiss Business Hub Japan
Issued by OSEC Business Network Switzerland
Lectures/Presentations
- January 2006: “Japan’s New Medical Device Law” Clinical Device Group, Inc (USA)
- July 2006: “GCP and Japanese specific requirements for clinical trials” Clinical Device Group, Inc (USA)
- September 2007: “Conducting clinical evaluation in Japan,” London, UK
- January 2009: "Revision of Japan's GCP Regulations" Clinical Device Group, Inc (USA)
- September 2009: "Workshop, Regulatory Challenges in the JapaneseMedical Device Market" Zurich, OSEC (Switzerland)
