About AMDD
Organization Structure
Organization Chart
Committee Overviews
STM Committee
The STM (special treatment material) Committee engages in a range of activities in cooperation with AdvaMed and related associations in Japan and Europe. The purpose of these activities is to establish appropriate reimbursement pricing to speed up the introduction of advanced medical technology and to facilitate a stable supply of products required in Japan.
Activities include undertaking research, comparing market environments (including the cost of doing business) in Japan and foreign countries and submitting recommendations on the Japanese insurance reimbursement system. Through regular meetings with the Ministry of Health, Labour and Welfare (MHLW) and by implementing industry hearings at the Central Social Insurance Medical Council the STM committee aims to influence reimbursement revisions undertaken every two years.
Takeo Morooka, Chairman, STM Committee
Covidien Japan Inc
Vice President
Government Affairs
Capital Equipment Committee
The Capital Equipment Committee consists of eleven corporate members working in the field of “medical instruments and devices including those used for imaging diagnostics and treatments” which fall under in the category of Medical Devices Eligible for Specific Medical Fee (i.e. medical devices other than medical materials and in-vitro diagnostics) for the purpose of remuneration for medical treatment under the Health Insurance System in Japan. We will focus on the promotion of the latest medical technologies from the U.S. and other countries, early approval/installation, advancement of safety-oriented environment for medical devices, as well as the international harmonization of the Japanese regulatory system concerning medical devices.
As one of the committees working under the AMDD, we are committed to building collaborative relationships with diverse stakeholders while maintaining our strong alliance with the American Chamber of Commerce in Japan (ACCJ).
Michael Bobrove, Chairman, Capital Equipment Committee
Representative Director and President, Nihon Medrad K.K.
Orthopedics Committee
The Orthopedics Committee is a high level forum for leaders of the orthopedic companies belonging to the AMDD. The Committee is a means by which many of the different and often interrelated issues associated with supplying orthopedic products to the market in Japan can be brought together and discussed.
It is a committee constantly looking for solutions to these issues with the aim of helping companies to bring the very best of their technologies to the patients and medical professionals of Japan.
Kazuya Ogawa, Chairman, Orthopedics Committee
President and Representative Director, Zimmer K.K.
IVD Committee
The IVD Committee represents in-vitro diagnostics (IVD) companies in their efforts to carry out a range of activities contributing to medical treatment that enhances patient quality of life (QOL) in Japan. Activities include the submission of recommendations concerning the reimbursement system for clinical examinations, and the pharmaceutical regulatory system for IVD and medical measurement equipment. The Committee also promotes the value of IVD and clinical testing.
IVD plays a key role within the Japanese healthcare system as clinical testing is necessary in the prevention, diagnosis, treatment and prognosis of diseases. The IVD Committee believes access to appropriate clinical testing will contribute to improving patient QOL, as well as the quality and price of patient treatment.
The Committee works in cooperation with other organizations including the Japanese Promotion Council for Laboratory Testing and Japan Association of Clinical Research, and will continue its efforts to raise awareness of IVD.
Isao Ikeda, Chairman, IVD Committee
President and CEO, Abbott Japan Co., Ltd.
RAQA Committee
The RAQA (regulatory affairs and quality assurance) Committee aims to speed up the introduction of global-standard medical devices to patients in Japan. To achieve this, the Committee engages in the following activities;
- Participates in a joint task force and action program review panel to achieve realization of the Ministry Health, Labour and Welfare’s (MHLW) action program to accelerate the approval process for medical devices
- Collaborates with the GCP Committee, Japan Federation of Medical Devices Association (JFMDA) to work towards standardizing and reducing the financial burden of medical device clinical trials
- Collaborates with MOSS (Market-Oriented Sector Selective) talks to submit recommendations regarding the abolition of the concept of “product specific QMS Confirmity Assessment” and the adoption of a system for simple registration of foreign manufacturing facilities from the current “Foreign Manufacturer Accreditation System,” with a view of reforming the Pharmaceutical Affairs Law
There is a major disparity in the access to medical devices in Japan (device lag), compared to the United States and Europe. A study conducted by RAQA Committee members last year, ‘The 2008 Device Lag Study’, revealed that patients in Japan have access to approximately half of the products available in the U.S. and EU. For at least the next five years the Committee will focus on eliminating the ‘device lag’ and speeding up the approval process.
Noriko Sato, Chairman, RAQA Committee
Biomet Japan, Inc.
Senior Manager, Regulatory Affairs Dept.
Public Awareness Committee
The AMDD’s member companies have worked together since 2002 to build an advocacy program to raise awareness of the value of advanced medical technology. Since 2002, AMDD member companies have worked in cooperation with the government to speed up the introduction of advanced medical technology to patients in Japan with the aim of enhancing their quality of life (QOL).
The Public Awareness Committee works to influence government policy and reform the healthcare system by presenting;
- Medical technology as part of a solution to high healthcare expenditure in Japan
- The link between improving patient quality of life and availability of the latest technology
- The need for a less burdensome and faster approval process to enable patients in Japan to benefit from the latest advances in medical technology
The Public Awareness Program Committee will continue to proactively provide information concerning the benefits of medical technology in order to respond to the increasing public interest in medical related information.
Bruce J. Ellsworth, Chairman, Public Awareness Committee
Director, Government Affairs Japan, Johnson & Johnson K.K.
Advocacy Committee
A new Advocacy committee was formed in AMDD in November 2009. Its duty is to report various proposals, critical concerns and information at directors' meetings and individual committees' meetings to stakeholders in all directions. This is necessary because innovations in new medical devices, in-vitro diagnostics, and medical technology, need to be recognized in the community and receive appropriate evaluation.
In order to provide detailed service and products that can respond to the needs of society, we must thoroughly discuss the medical care system in Japan with policy planners and associations concerned with medical treatment. We wish to contribute to creating an environment that makes it easy to introduce medical technology which improves the welfare and treatment of patients, by cooperating with the Public Awareness Committee, which transmits information to society.
We are already coordinating the points at issue in administrative body-private company dialogues, providing input concerning strategy for the growth of the medical devices field, and cooperating with business associations in Japan and overseas to accompany these activities. We sincerely hope for your cooperation.
Mitsunobu Sato, Chairman of AMDD Advocacy Committee
Director of Japan Healthcare Economics and Government Affairs
Medtronic Japan Co., Ltd.
