News –
- 2024 EBC Medical Equipment/IVD Committee Representative meeting was held on December 12, 2024.(go to News section)
- Public-private dialogue meeting to create innovative pharmaceuticals, medical devices, regenerative medicine, and other products was held on November 21, 2024.(go to News section)
- 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 expenditure in fiscal 2023 reached a level exceeding 8% of gross domestic product, and aging and increasing chronic diseases continue to weigh heavily on healthcare financials. Promotion of medical innovation and optimization of medical expenditure are still the most important issues. However, the digitalisation of medical sites and improvement of labour productivity are not sufficiently advanced, and structural issues remain. In particular, uneven distribution of specialists and shortage of human resources, the damage to medical institution management due to delayed response to infectious diseases, as well as soaring raw material cost and exchange rate fluctuations due to geopolitical risks, pose a new threat to the stable supply system for medical care.
Under these circumstances, in order for Japan’s healthcare system to continue functioning sustainably and stably, a paradigm shift is essential—one that not only reforms the system itself but also shifts the focus toward healthcare that maintains health and prevents illness. This transformation must be accompanied by the social implementation of technological innovations such as digital health and the safe and effective use of medical data to improve the efficiency of healthcare services.
The use of AI・IoT to monitor patient conditions, detect abnormal conditions at an early stage, and secure sharing of diagnostic findings enables timely and appropriate medical intervention. This helps to reduce the burden on patients, curtail medical costs, and thereby extend the healthy life expectancy and maintain the workforce.
Furthermore, securing a stable supply is an urgent issue. The segmentation of the global supply chain and the volatility of exchange rates and prices have a serious impact on Japan, which is heavily dependent on imports of medical equipment and pharmaceuticals. It is necessary to establish a strategic supply system and a transparent procurement system.
The key to the smooth introduction of innovative healthcare technologies is the development of an innovation assessment system and the improvement of predictability and speed in Insurance reimbursement. In Europe, UNBRERA (Unified Benefit-Risk Evaluation for Rapid Access) has been advocated as a more comprehensive system in addition to DiGA (digital health applications) as a framework for medical apps and digital treatments, and both rapid assessments based on scientific evidence and accessibility support are being achieved. In Japan, discussions should also take into account the introduction of a similar framework.
Although some functionality has been introduced to allow viewing of health checkup and medication information using the My Number Card, progress in integrating this with personal health records (PHRs) has been slow, and the overall vision for digital transformation in healthcare remains insufficient. For the social implementation of cloud-based medical infrastructure and software-based medical devices—such as the permanent establishment of online medical consultations, incentivizing healthcare institutions to adopt cloud systems through reimbursement revisions, and the use of telemedicine and remote caregiving monitoring—international harmonization is essential. This must take into account regulations such as the European Union’s General Data Protection Regulation (GDPR) and cybersecurity measures. Continued efforts to promote foreign direct investment (FDI) are also necessary.
EBC Medical equipment and IVD Committee will continue to promote policy-making activities utilising the following in order to contribute to the structural reform of the Japanese healthcare system and industry by taking advantage of advanced European technologies and institutions.
- Access to regulatory and technological developments overseas, including in the Europe
- Insights from a diverse range of member companies and a highly specialised reimbursement committee
- A proven policy network with government agencies, the Japanese Parliament, and academic associations
- Strengthening private-sector policy proposals through collaboration with related domestic organizations
Based on these, EBC will continue to contribute to the upgrading of the Japanese healthcare system and the strengthening of the stable supply system, as well as to the enhancement of the global competitiveness of the healthcare Industry.
Key issues and recommendations
-
Published:
Revision of insurance coverage and functional classification of insurance medical material
status:
Progress -
Published:
Foreign Price Reference System (Measures to Ensure Stable Supply)
status:
No progress -
Published:
Treatment of the cost accounting method
status:
New -
Published:
Clarification of unprofitable products (measures to ensure stable supply)
status:
New -
Published:
Reevaluation of Insurance application system (challenges) according to actual usage
status:
Progress -
Published:
Evaluation to improve medical treatment efficiency and reduce the burden on medical practitioners (work style reform/hatarakikata kaikaku)
status:
No progress -
Published:
Scope of application of programmes for medical devices including artificial intelligence and insurance coverage
status:
Good progress -
Published:
Proper evaluation of nuclear medicine diagnosis and treatment
status:
Progress -
Published:
Global standards for clinical evaluation
status:
Negative progress -
Published:
Audit system adapted to characteristics of program medical equipment
status:
Progress -
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 Asia Pacific Japan Region Varian Medical Systems K.K. / Director Siemens Healthcare K.K.
c/o 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.
Molnlycke Health Care KK
Nippon BXI Inc.
PARI Japan GK
Philips Japan, Ltd.
TR3, Inc.
Upcoming committee meeting schedule
Please contact the EBC ( [email protected] ) to confirm the meeting location prior to attending
DATE | TIME | LOCATION |
---|---|---|
2025 | ||
January 23 (Thursday) | 14:30~ | Off-Site |
February 19 (Wednesday) | 14:30~ | Off-Site |
March 21 (Friday) | 14:30~ | Online |
April 17 (Thursday) | 14:30~ | Off-Site |
May 22 (Thursday) | 14:30~ | Off-Site |
June 19 (Thursday) | 14:30~ | Off-Site |
July 24 (Thursday) | 14:30~ | Off-Site |
August 28 (Thursday) | 14:30~ | Off-Site |
September 18 (Thursday) | 14:30~ | Off-Site |
October 23 (Thursday) | 14:30~ | Off-Site |
November 12 (Wednesday) | 14:30~ | Off-Site |
December 11 (Thursday) | 14:30~ | Off-Site |
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)