- 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)
The total cost of medical care for Japan in the fiscal year of 2019 was 43.3 trillion yen, up 0.8% 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. However, healthcare delivery is becoming extremely complex, because of labour shortages stemming from the decreasing birth rate and an ageing population, shortages of specialists in ICU (Intensive Care Unit) pathology, and the decline in business, or business failure, of a significant number of hospitals and clinics.
In order to improve the situation and for the increase in raw material prices triggered by the Russian-Ukrainian war, as well as supply uncertainty and the sharp rise in exchange rate fluctuationsit is important to promote medical system reforms and technological innovations centred on digital health so that stable supply will not be hindered even by coronavirus. In addition, the EBC believes there is important to shift from “medical care to treat illness” to “healthcare to maintain health and prevent illness”, and to promote the utilisation of medical information and the efficiency of medical services. 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.
Innovative European medical equipment, materials and services can help Japan to meet its healthcare challenges. 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.
In Japan, the introduction of PHR (Personal Health Record) has been promoted since FY2020, and online medical treatment for COVID-19 is also underway. Cloud integration and consolidation of medical institutions is required. 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
Revision of insurance coverage and functional classification of insurance medical material
Foreign price reference system
Institutionalisation of insurance application system (C2 challenge) based on actual usage
Scope of application of programmes for medical devices including artificial intelligence and insurance coverage
Audit system adapted to characteristics of program medical equipment
Procedures for suspension of supply
Treatment of the cost accounting method
Global standards for clinical evaluation
QMS mutual recognition and global standards
Mutual recognition and global standards of medical equipment license
President & CEO, Siemens Healthcare K.K.
Gate City Osaki West Tower,
1-11-1 Osaki, Shinagawa-ku, Tokyo 141-8644
EBC Medical Equipment and Diagnostics Committee Secretariat contact:
Dornier MedTech Japan Co., Ltd.
Draeger Medical Japan Ltd.
Edaptechnomed Co., Ltd.
Guerbet Japan K.K.
Upcoming committee meeting schedule
Please contact the EBC ( [email protected] ) to confirm the meeting location prior to attending
|January 26 (Thursday)||14:30~||Off-Site|
|February 24 (Friday)||14:30~||Off-Site|
|March 23 (Thursday)||14:30~||Off-Site|
|April 20 (Thursday)||14:30~||Off-Site|
|May 25 (Thursday)||14:30~||Off-Site|
|June 22 (Thursday)||14:30~||Off-Site|
|July 20 (Thursday)||14:30~||Off-Site|
|August 24 (Thursday)||14:30~||Off-Site|
|September 21 (Thursday)||14:30~||Off-Site|
|October 19 (Thursday)||14:30~||Off-Site|
|November 16 (Thursday)||14:30~||Off-Site|
|December 7 (Thursday)||14:30~||Off-Site|
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)
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.
- 20th Periodic meetings to exchange opinions on approval reviews and safety measures for medical devices and in vitro diagnostics (PDF)
Webinar on “German DiGA Process – Update 2022” was held on November 7, 2022.
A representative meeting was held, and each subcommittee and task force reported the 2021 activity report and the 2022 activity policy.
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)