Committee Overviews

The STM (Special Treatment Materials) committee is engaged in the following activities in collaboration with AdvaMed and other industry associations in Japan and Europe to propose and implement a sustainable reimbursement system to ensure that innovative and valuable medical devices are promptly introduced into Japan and delivered to patients in a stable manner.

• Propose an appropriate evaluation system for innovative and valuable　medical devices (promotion of Value-Based Healthcare)
• Propose appropriate reimbursement repricing rules for existing products in accordance with the Japanese healthcare system.
• Propose an appropriate system to evaluate cost-effectiveness that considers the nature of medical devices.

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

The AMDD Orthopedics Committee comprises leading multinational companies that specialize in the research, design and manufacture of orthopedic medical devices. Committee member companies maintain significant business operations in Japan.

Orthopedic medical devices, which include reconstructive joint implants, spine implants, bone plates, screws and cement, sports medicine, biologic treatments and more, allow for a better quality of life for patients suffering from a variety of musculoskeletal conditions, including osteoarthritis and traumatic injuries. This is especially important for Japanese patients whose average life expectancy ranks among the top worldwide. Orthopedic devices can allow for a more active and healthy lifestyle, which, as recent studies have shown, can help improve cardiovascular health and reduce the risk of dementia. These devices also help yield significant benefits to Japan’s economy and social security system.

This Committee endeavors to communicate the benefits of orthopedic medical devices. The Committee is also committed to working with Japanese stakeholders in support of public policies, which recognize and value orthopedic medical devices, and ensure swift patient access to safe and effective devices.

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.

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.

The Public Affairs Committee works within AMDD and with external stakeholders to:

• Further increase awareness of AMDD and the value provided to patients/society by its products.
• Reduce Information Asymmetry in Healthcare to help patients be detected and treated by the best way at the best timing in a satisfied manner.
• Create venues to share information and to discuss on actions needed so we can provide valuable medical technologies and information for Japan sustainably.

The AMDD Advocacy Committee was launched in November 2009 in order to establish a platform through which different stakeholders can come together and collaboratively tackle and solve the challenges facing AMDD member companies. The Committee produces information and proposals that support and contribute to AMDD’s mission of “Enabling a Healthier Japan.”

In June 2010, the Committee was responsible for ensuring that recommendations on “Issues Regarding to Medical Device/IVD Market and Idea of Solutions - Proposals to realize better healthcare in Japan” were communicated to influential government ministers. Thanks to its ongoing communication with policymakers and wider stakeholder engagement, the Committee contributed to eliminating Japan’s “device lag” and the enacting of the “Pharmaceutical and Medical Device Act (PMD Act).”

In February 2020, the Advocacy Committee identified new challenges facing AMDD members and begun pro-active steps to solve these. Through these activities, AMDD aims to raise levels of public awareness and informed understanding of the latest innovations in medical devices, IVDs, and medical technologies and ultimately realize its vision of a society in which these are widely and safely adopted.

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.

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.

The purpose of the Distribution & IT Committee activities is to consider and evaluate requirements and element technologies that are needed to streamline efficiency in medical device distribution. The Committee also disseminates this information to AMDD member companies. The scope of activities include:

• Examine medical distribution requirements specified by public authorities and develop practical means for each member company to carry out these requirements
• Evaluate element information technology that can improve distribution efficiency, including RFID, AI, and RPA, and develop implementation strategies.
• Explore strategies for evaluation and implementation of automated distribution technologies such as EDI and cloud-based data platforms.
• Collaborate and exchange opinions with hospitals, dealers, public authorities, and other industry groups, in order to promote more efficient medical device distribution.

AMDD Digital Health Committee will promote four “connects” for the issues that member companies will tackle and aim to contribute to the digital transformation in medical & health care in Japan through solving the issues.

• Connect inside AMDD: Support member companies to have effective cooperation with each committee on the medical digitization related issues.
• Connect AMDD and stakeholders: Play a role as a window for AMDD in collaborating with various stakeholders to solve issues.
• Connect the world and Japan: Share the best practices of the world within Japan and support to demonstrate Japanese initiatives to the world.
• Connect present and future: Comprehend the future technologies accurately, anticipate issues from backcasting point of view, and propose countermeasures.