AMDD Submits Recommendations for "Basic Policy on Economic and Fiscal Management and Reform 2026"

The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD), located in Minato-ku, Tokyo, with Tomoyuki Morikawa as its Chairman, has submitted the following recommendations for this year's "Basic Policy on Economic and Fiscal Management and Reform" (often referred to as "Honebuto Hoshin"), aiming to foster innovation and ensure the continued provision of high-quality medical care through public-private collaboration.

*Summary* [Recommendation 1] Consideration of flexible insurance reimbursement prices for medical devices and IVDs in response to changes in external environments such as inflation ・Response to continuous cost increases such as price and wage hikes.

・Appropriate response to the "negative margin" situation where the purchase price by medical institutions exceeds the reimbursement price.

・Appropriate and flexible increase in material prices.

[Recommendation 2] Promotion of international harmonization of pharmaceutical and medical device regulations to resolve device lag and device loss in Japan ・Ensuring international consistency in pharmaceutical and medical device regulations (review requirements, reliability assurance of real-world data, etc.).

・Creating an environment to revitalize the development of medical devices and IVDs in Japan.

・Standardizing processes related to clinical trials and studies.

[Recommendation 3] Promotion of the introduction of digital health technologies that contribute to improving the operational efficiency of medical institutions and reducing the burden on healthcare professionals ・Improving the operational efficiency of medical institutions and reducing the burden on healthcare professionals through the introduction of digital health technologies.

・Introduction, continuation, and expansion of new evaluation systems or support systems for medical institutions.

・Promotion of demonstration research on digital health technologies that contribute to productivity improvement.

[Recommendation 4] Establishment of a system that allows the public to access correct information regarding diagnosis and treatment using medical devices and IVDs ・Clarification of rules regarding information dissemination from manufacturers and distributors.

・Promotion of accurate and easy-to-understand information provision about medical devices and IVDs to enable the public to make informed choices about diagnosis and treatment.

・Promotion of awareness activities that contribute to improving the public's health literacy.

[Recommendation 5] Promotion of secondary use of medical data through public-private collaboration and promotion of database linkage including identification information for medical devices and IVDs ・Promotion and acceleration of the development of medical device and IVD products utilizing medical data.

・Linkage of various databases, including identification information for medical devices and IVDs.

・Strengthening public-private collaboration through sharing of issues and case studies with relevant government departments.

AMDD will continue to work towards contributing to people's health and the development of Japanese healthcare by collaborating with the Japanese and US governments, related industry associations, academic societies, medical professionals, and many others.

*The full text of these recommendations can be downloaded from here.

About the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) AMDD is composed of companies primarily headquartered in the United States or conducting business in the United States that handle medical devices and in-vitro diagnostics (IVDs). By collaborating with a wide range of stakeholders, including the Japanese and US governments, related industry associations, academic societies, and medical professionals, AMDD aims to contribute to the development of Japanese healthcare by providing the latest medical technologies (diagnostic and therapeutic technologies) and information. For more details, please visit the AMDD website.