About AMDD

 

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.

Tamura Makoto

Toshifumi Hayashi, Chairman, STM Committee
Director, Government Affairs
Zimmer Biomet G.K.

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Capital Equipment Committee

The Capital Equipment Committee consists of corporate members working in the field of “medical instruments and devices including those used for imaging diagnostics and treatments” (i.e. specific medical supplies other than medical materials and in-vitro diagnostics). And we discuss for the purpose of promoting policy to accelerate introduction of medical technologies contributing to improving medical practice and patients quality of life.

  • Promoting transparency, prompt approval and introduction and rewards to innovative advanced medical technology
  • Promoting safety management of medical devices
  • Promoting global harmonization of medical device regulations in Japan
Eriko Asai

Masumi Iwama, Chairman, Capital Equipment Committee
Director, Government Affairs and Policy
Intuitive Surgical G.K.

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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

Kazuya Ogawa, Chairman, Orthopedics Committee
Chairman
Zimmer Biomet G.K.

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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 QOL and health promotion in Japan. To speed up to introduce advanced IVD technology in Japan, our activities include the submission of recommendations concerning the reimbursement system for clinical testing and the regulatory system for IVD. The Committee also promotes the value of IVD and clinical testing.

IVD plays a key role within the Japanese healthcare system and is used in various stages in medical care, i.e. 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 medical treatment.

The Committee works in cooperation with other organizations including the Japan Association of Clinical Reagents Industries, European Business Council in Japan and Advanced Medical Technology Association and will continue its efforts to maximize the value of IVD.

Haruyoshi Sakamoto

Shinobu Sato, Chairman, IVD Committee
Director, Business Excellence
Abbott Japan Co., Ltd.

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RAQA Committee

The RAQA (regulatory affairs and quality assurance) Committee aspires to:

  • Shorten the introduction period of necessary medical devices and IVDs in Japan in order to provide the latest medical technologies to the Japanese people
  • Develop proposals on the ideal post market regulations of medical devices and IVDs
  • Provide administrative training opportunities related to pre/post market regulations in order to make Japanese regulations internationally consistent.

In order to align with the global situation on pre/post market regulations, the RAQA Committee commits to providing timely information and proposals, and contributing to improving rules and regulations. The RAQA Committee also works towards collecting global information on relevant regulations while simultaneously conveying those of Japan globally.

Based on past achievements of “shortening device lag” and “accelerating the approval process,” the RAQA Committee continues to work on new issues, such as balancing pre/post market regulations.

Masanori Otake

Aya Saeki, Chairman, RAQA Committee
Director
Regulatory Affairs, VCC Division
Edwards Lifesciences Limited

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Public Awareness Committee

Along with raising awareness of AMDD, the Public Awareness Committee disseminates a variety of information regarding advanced medical technology, and also works in cooperation with other committees to promote AMDD’s proposals to improve the Japanese medical system.

Under AMDD’s mission of “improving the welfare of patients in Japan by using the latest medical technologies,” the PA committee’s activities focus on the following messages:

  • Promote understanding of the role and value of advanced medical devices and IVDs in improving patients’ QOL.
  • Increase awareness of the seriousness of the “device lag” and “device gap” issues, in which some advanced medical devices widely used in Western countries are not available in Japan, and AMDD’s proposal to resolve these issues.
  • Increase awareness of AMDD’s proposal to establish a regulatory system that takes into account devices’ attributes.

The PA committee will increase awareness of AMDD’s activities and provide information from a global perspective in order to contribute to healthcare in Japan.

Yoko Mukai

Yoko Mukai, Chairman, Public Awareness Committee
Associate Director, Communications
Nippon Becton Dickinson Company, Ltd.

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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.

Jun Sekiguchi

Jun Sekiguchi, Chairman, Advocacy Committee
Director, Government Affairs & Policy
Johnson & Johnson Family of Companies in Japan

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Legal & Compliance Committee

The Legal Compliance Committee aims to build and strengthen a compliance system in order to ensure that AMDD member companies’ corporate activities are carried out in accordance to laws and regulations. The committee gathers and analyzes information related to legal compliance both in Japan and overseas, and makes proposals on the necessary steps required to achieve compliance to the AMDD’s Executive Committee.

Masahiko Oka

Koichiro Miyata, Chairman, Legal & Compliance Committee
Senior Director, General Counsel, Legal Division
Medtronic Japan Co., Ltd.

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Membership Committe

The Membership Committee invites new companies to join AMDD and organizes internal events to promote communication among member companies, such as the Monthly Meeting, General Meeting, and New Year Party. The committee also conducts a satisfaction survey to gather feedback from member companies on AMDD activities.

Shigeyuki Masukawa

Shigeyuki Masukawa, Chairman, Membership Committee
Vice President, Operations & Corporate Support
Boston Scientific Japan K.K.

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