News –
- The 22nd Regular Meeting on Approval Review and Safety Measures for Medical Devices and In Vitro Diagnostics was held (2024.10.07) (go to News section)
- Lecture and information exchange meeting was held to commemorate the 40th anniversary of the founding of the Medical Equipment and IVD Committee (2024.08.22) (go to News section)
- 2023 EBC Medical Equipment/IVD Committee Representative meeting and information exchange meeting was held on December 7, 2023. (go to News section)
- Public-private dialogue meeting to create innovative medicines, medical devices, regenerative medicine products, etc. was held on November 13, 2023. (go to News section)
- A regular opinion exchange meeting was held on September 14, 2023. (go to News section)
- A regular meeting with the Ministry of Health, Labor and Welfare was held on July 12, 2023. (go to News section)
- On Thursday 24 August 2023, the EBC Medical Equipment and IVD Committee organised a lecture and information exchange meeting at the Akasaka International Conference in Tokyo.(go to News section)
- Presentation materials for the meeting of representatives of the Medical Devices IVD Committee held on December 8, 2022 have been released.
(go to News section) - Presentation materials for Public Private Sector Dialogue held on November 28, 2022 have been released.(go to News section)
- Presentation materials for 20th periodic meetings to exchange opinions on approval reviews and safety measures for medical devices and in vitro diagnostics held on September 1, 2022 have been released.(go to News section)
- Webinar on “German DiGA Process – Update 2022” was held on November 7, 2022 (go to News section)
- A representative meeting was held on December 9, 2021 (go to News section)
- A representative meeting was held on December 10, 2020 (go to News section)
Japan’s national healthcare expenditures in fiscal 2021 amounted to ¥45.0359 trillion, or 8.18% of the gross domestic product (GDP), up 4.8% from the previous year. In many other respects, the main challenges remain as before, including changes to the overall disease profile driven by the ageing of the population and a rise in chronic conditions, and the promotion of medical innovation in parallel with controls on medical costs. On the other hand, the labor force is about to change greatly due to the labor participation of the elderly and the participation of women in society, but the improvement of labor productivity by digitalisation, which has been delayed globally due to the corona scandal, is slow, despite various policy guidance. The healthcare sector is also becoming increasingly complex, with the shortage of specialists, including ICU and disease, and delays in responding to infectious diseases leading to financial difficulties and bankruptcies at medical institutions. In addition, rising raw material prices stemming from Ukraine and large fluctuations in exchange rates that began in the United States have caused supply uncertainty.
To achieve this, it is urgent to reform the medical system in order to solve the stable construction of the medical supply system. Furthermore, in order to promote technological innovation centered on digital health, it is important to simultaneously promote the paradigm shift from “medical care to treat diseases” to “healthcare to prevent diseases” and the utilization of medical information and the efficiency improvement of medical services through it. In digital healthcare, it is important to detect early abnormalities by monitoring health conditions, make accurate and definitive diagnoses, securely share diagnosis results, and realise timely and efficient medical services. We believe that introducing and instilling these services in society as a system will reduce the burden on patients. At the same time it will also reduce medical expenses, increase the healthy population and labour force, and eventually lead to social and economic growth.
In order to continue to provide high-quality healthcare services in today’s environments, it is essential to properly introduce European innovative Medical equipment and healthcare materials and institutional designs. To do this, Japan should align its regulations and processes with international standards, allow use of European approvals and data, and improve the predictability of the reimbursement system. Moreover, information on the Japanese medical care system should be provided internationally in multiple languages to encourage more overseas businesses to participate in the Japanese market.
My Number cards, which are linked to bank information and licenses, have been introduced with medical checkup information and drug information inspection functions, but collaboration with PHR in the healthcare field has not progressed slowly. On the other hand, it is expected that online medical treatment for coronavirus will become permanent, and that the cloud and consolidation of medical institutions will advance by reviewing appropriate remuneration, etc. It is hoped that the following measures will be continued: Efficient medical services will be provided by digitalisation of medical data; Cyber security implemented in Europe toward introduction of medical equipment using IoT (Internet of Things) and AI (Artificial Intelligence); appropriate responses to GDPR (General Data Protection Regulation) etc.; Trial introduction and operation in Japan such as DiGA (Digital Health Applications) etc, and FDI (Foreign Direct Investment) measures that European companies can participate in.
The EBC Medical Equipment & Diagnostics Committee intends to continue working in cooperation with the Japanese Government, especially the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) and other associated industrial organisations, and will present recommendations in order to help reform the Japanese medical system and industrial structure. The aim will be the deployment in Japan of not only excellent medical equipment but also advanced healthcare models and effective medical systems, where we believe Europe has much to offer.
Key issues and recommendations
-
Published:
Proper evaluation of nuclear medicine diagnosis and treatment
status:
Progress -
Published:
Evaluation to improve medical treatment efficiency and reduce the burden on medical practitioners (work style reform)
status:
No progress -
Published:
Clarification of unprofitable products (measures to ensure stable supply)
status:
New -
Published:
Revision of insurance coverage and functional classification of insurance medical material
status:
Progress -
Published:
Foreign price reference system
status:
No progress -
Published:
Reevaluation of insurance application system (challenges) based on actual usage
status:
Progress -
Published:
Scope of application of programmes for medical devices including artificial intelligence and insurance coverage
status:
Good progress -
Published:
Global standards for clinical evaluation
status:
Negative progress -
Published:
Audit system adapted to characteristics of program medical equipment
status:
Progress -
Published:
Treatment of the cost accounting method
status:
New -
Published:
Procedures for suspension of supply
status:
New -
Published:
QMS mutual recognition and global standards
status:
Some progress -
Published:
Mutual recognition and global standards of medical equipment license
status:
Some progress
Chairman
President & CEO, Siemens Healthcare K.K.
Gate City Osaki West Tower,
1-11-1 Osaki, Shinagawa-ku, Tokyo 141-8644
Tel: +81-3-3493-7500
Fax: +81-3-3493-7654
EBC Medical Equipment and Diagnostics Committee Secretariat contact:
E-mail: EBC-MDX@ebc-jp.com
Members
Dornier MedTech Japan Co., Ltd.
Draeger Medical Japan Ltd.
Edaptechnomed Co., Ltd.
TR3, Inc.
Upcoming committee meeting schedule
Please contact the EBC ( [email protected] ) to confirm the meeting location prior to attending
2024
DATE | TIME | LOCATION |
---|---|---|
January 25 (Thursday) | 14:30~ | Off-Site |
February 20 (Tuesday) | 14:30~ | Off-Site |
March 21 (Thursday) | 14:30~ | Off-Site |
April 18 (Thursday) | 14:30~ | Off-Site |
May 23 (Thursday) | 14:30~ | Off-Site |
June 21 (Friday) | 14:30~ | Off-Site |
July 18 (Thursday) | 14:30~ | Off-Site |
August 22 (Thursday) | 14:30~ | Off-Site (+ Information exchange meeting) |
September 19 (Thursday) | 14:30~ | Off-Site |
October 17 (Thursday) | 14:30~ | Off-Site |
November 14 (Thursday) | 14:30~ | Off-Site |
December 12 (Thursday) | 14:30~ | Off-Site (Representative meeting + Information exchange meeting) |
News
Presentation materials for the meeting of representatives of the Medical Devices IVD Committee on December 8, 2022 have been released.
- EBC Remarks by the Chairman of the Board of Representatives (PDF)
- Secretariat Report (PDF)
- Digital Health Task Force (PDF)
- Regulatory Affairs Committee (PDF )
- IVD Subcommittee (PDF)
- Medical Fee Subcommittee (PDF)
Presentation materials for Public Private Sector Dialogue held on November 28, 2022 have been released.
- EBC Draft for Public Private Sector Dialogue in 2022 (PDF)
- Public Private Dialogue for the Creation of Innovative Medical Devices and In Vitro Diagnostics(PDF)
EBC Medical Devices and IVD Committee Meeting of Representatives, December 10, 2020
A representative meeting was held, and reported about each subcommittee annual activities and a report on the joint project “Mira Pro” between the industry and the government.
- Speech by the Chair [PDF]
- Report of the Reimbursement Subcommittee [PDF]
- Report of the Pharmaceutical Affairs Subcommittee of PMDA [PDF]
- Report of the IVD Subcommittee [PDF]
- Report of “Project to Develop the Human Resources that will Carry the Future of Medical Devices” (Abbreviation: Mirapro Project) [PDF]
The EBC Medical Equipment Committee, together with the Japan Federation of Medical Devices Associations (JFMDA) and the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) jointly submitted in April a letter to the Product Safety Division of METI on voluntary Actions related to Direct Current Power Supply Unit (AC adaptor)