American Medical Device and IVD Industry Association (General Incorporated Association)
AMDD submits recommendations for “Basic Policy for Economic and Fiscal Management and Reform 2024”
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The American Medical Devices and Diagnostics Manufacturers’
Association (AMDD), located in Minato-ku, Tokyo, Chairman: Takanao Tamai, is pleased to announce the recently formulated Basic Policy for Economic and Fiscal Management and Reform. We have made the following recommendations in order to share the direction of reform under the “Basic Policy for 2024” and to work together with the public and private sectors to achieve this, particularly with the aim of extending the nation’s healthy life expectancy and promoting innovation in medical care.
-summary*-
Recommendation 1: Develop an environment to quickly and appropriately provide medical technology such as digital health technology ・Central aggregation and unified development by the government of “Forms for responding to cyber security”
・Further clarification of evaluation criteria for innovative medical technology and improvement of evaluation system
Recommendation 2: Efforts to resolve factors that impede the stable supply of medical devices and in vitro diagnostic drugs
・Based on the background of global price and material cost hikes, exchange rate fluctuations, and the 2024 logistics problem, we will continue to hold meetings on improving the distribution of medical devices and other in vitro medical devices. Promote public-private efforts to resolve various factors that impede the stable supply of diagnostic drugs (IVDs)
Recommendation 3: Proposal for the revision of the Pharmaceutical and Medical Device Act (Pharmaceutical Device Act) scheduled for 2025 ・Review of advertising regulations based on the characteristics of medical devices
・Organize and simplify the legal system related to clinical trials and clinical research to revitalize medical device development in Japan ・Review and rationalization of classification and positioning of in vitro diagnostic drugs (IVD) and pre-approval testing
Recommendation 4: Establishment and operation of a medical information provision system
・Construction and operation of a government-led medical information provision system in response to the need for an appropriate
information provision system as people improve their health literacy. AMDD will continue to work together with the governments of Japan and the United States, related industry groups, academia, medical professionals, and many others in order to contribute to people’s health and the development of medical care in Japan. .
that’s all
*Please download the full text of this proposal here
(https://prtimes.jp/a/?f=d139421-2-d5bb35df9d56452fd561fcbac8304a98.pdf). About the American Medical Device and IVD Industry Association (AMDD) An industrial association primarily comprised of companies that handle medical devices and in vitro diagnostic drugs (IVD) that are headquartered in or do business in the United States. We aim to keep Japan healthy by providing the latest medical technology (treatment technology and diagnostic technology) and information in response to the needs of Japanese medical sites and patients. The member companies of this industry association not only import and sell products, but also engage in close cooperation with the Japanese medical device industry, including research and development and manufacturing in Japan, and the use of parts developed and manufactured in Japan in their products. have a relationship.
Name: American Medical Device and IVD Industry Association
Address (secretariat): 5th floor, Shiodome City Center, 1-5-2 Higashi-Shinbashi, Minato-ku, Tokyo 105-7105
Representative: Chairman Takanao Tamai
AMDD homepage: https://amdd.jp/
[The press release can also be viewed as a PDF version here. ] https://prtimes.jp/a/?f=d139421-2-103d0a6765b794cd90ba8582942bd3d0.pdf More details about this release:
https://prtimes.jp/main/html/rd/p/000000002.000139421.html