*Note: This English translation is for reference purposes only. In the event of any discrepancy between
the Japanese original and this English translation, the Japanese original shall prevail.

May 14, 2024
Takanao Tamai, Chairperson
American Medical Devices and Diagnostics Manufacturers’ Association

AMDD’s Policy Proposal on theBasic Policy on Economic and Fiscal Management and Reform 2024
We are navigating unprecedented changes, including the pandemic and its societal
impacts, escalating geopolitical uncertainties, evolving economic fluctuations,demographic shifts, and the advancement of generative AI. The Japanese healthcare
system is also in need of transformation, and at AMDD, we are relentlessly working toensure stable medical supplies and continue to deliver the benefits of cutting-edge
medical technologies to patients.
Innovation and partnerships are key to adapting to these constant changes. Sharing thedirection of the Basic Policy on Economic and Fiscal Management and Reform, andaiming at the extension of healthy life expectancy and advancement of medical
innovation through public-private partnerships, AMDD proposes the following.
1. In order to promptly and effectively deliver digital health technologies and othermedical technologies to patients, AMDD proposes:a. Central unification and organization of the form on cybersecurity measures by
the government, which is required to be submitted by manufacturers to
medical institutions when implementing cloud-based or internet-connected
medical devices and in vitro diagnostics (IVD) in medical facilities.
b. Further clarification of assessment criteria and enhancement of the assessment
scheme in health insurance reimbursements for digital health technologies andother innovative medical technologies (including application of MedicalExpenses Combined with Treatment Outside Insurance Coverage).
2. Global price hikes for commodities including materials and currency exchange
fluctuations are significantly impacting our product cost structures and posing
1issues for the stable supply of products to the clinical environment and patients.
This situation is impacted further by the “2024 Logistics Problem” stemming fromthe work style reform in the industry.
Against this backdrop, AMDD proposes that the public and private sectors continue
to work together hand-in-hand to resolve the diverse factors that interfere withstable product supply, including the dialogue at the Council for the Improvement ofCommercial Transaction Practices of Medical Device, which was held for the firsttime in seven years last year.
3. Pertaining to the amendments to the Act on Securing Quality, Efficacy and Safetyof Products Including Pharmaceuticals and Medical Devices expected in FY 2025,
AMDD proposes:
a. Revision of regulations on advertising considering the attributes of medicaldevices.
b. Organization and simplification of legal systems concerning clinical trials andclinical studies to enhance medical device development in Japan.
c. Shifting the classification and positioning of IVDs from pharmaceuticals to
medical devices (for international harmonization), and the review andstreamlining of pre-approval studies at the National Institute of Infectious
Diseases.
4. As abundant information on medicine and treatment is available online today, there
is a crucial need to improve people’s health literacy as well as to build a system forappropriate information delivery.
In this context, AMDD proposes that the government leads the development andoperation of a system that will enable patients, their families, and the general public
to access reliable medical information in a timely and easy manner.

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