AMDD Submits Proposals for the 'Basic Policy on Economic and Fiscal Management and Reform 2026'

The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD, located in Minato-ku, Tokyo, Chairman: Tomoyuki Morikawa) has submitted the following proposals for this fiscal year's "Basic Policy on Economic and Fiscal Management and Reform (Honebuto Policy)", aiming to work together as a public-private entity to promote innovation and continue providing high-quality healthcare. [Proposal 1] Examination of flexible insurance reimbursement pricing for medical devices and IVDs in response to changes in the external environment such as inflation - Responding to continuous cost increases such as rising prices and wages - Appropriate response to the "negative margin" where the purchasing price for medical institutions exceeds the reimbursement price - Implementation of appropriate and flexible increases in material prices [Proposal 2] Promotion of international harmonization of pharmaceutical regulations toward eliminating device lag and device loss in Japan - Ensuring international consistency in pharmaceutical regulations (review requirements, assurance of reliability of real-world data, etc.) - Environmental development to revitalize medical device and IVD development in Japan - Standardization of processes related to clinical trials and studies [Proposal 3] Promotion of the introduction of digital health technologies contributing to the operational efficiency of medical institutions and reducing the burden on healthcare workers - Improving the operational efficiency of medical institutions and reducing the burden on medical 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 contributing to productivity improvement [Proposal 4] Establishment of a mechanism allowing the public to access accurate information regarding diagnosis and treatment using medical devices and IVDs - Organizing rules regarding information dissemination from manufacturers and distributors - Promoting the provision of accurate and easy-to-understand information regarding medical devices and IVDs for the public to proactively choose diagnostics and treatments - Promotion of educational activities contributing to improving the health literacy of the public [Proposal 5] Promotion of secondary use of medical data through public-private partnerships and the promotion of database linkage including medical device/IVD identification information - Promotion and acceleration of medical device and IVD product development utilizing medical data - Linkage of various databases including medical device and IVD identification information - Strengthening public-private partnerships through sharing issues and case studies with relevant government departments AMDD will continue to advance its activities to contribute to people's health and the development of Japanese medicine while cooperating with many stakeholders, including the US and Japanese governments, related industry associations, academic societies, and medical professionals. *Please download the full text of this proposal from here. About the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) AMDD is comprised of companies dealing in medical devices and in vitro diagnostics (IVDs) that are primarily headquartered in the US or do business in the US. By collaborating with a wide range of stakeholders, including the US and Japanese governments, related industry associations, academic societies, and medical professionals, we aim to contribute to the development of Japanese healthcare through the provision of the latest medical technologies (diagnostic and therapeutic technologies) and information. For details, please visit the AMDD website.