Medical Equipment

News –

 

  • 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, it 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 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

Upcoming committee meeting schedule

Please contact the EBC ( [email protected] ) to confirm the meeting location prior to attending

2022
DATETIMELOCATION
January 20 (Thursday)14:30~Off-Site
February 24 (Thursday)14:30~Off-Site
March 24 (Thursday)14:30~Off-Site
April 21 (Thursday)14:30~Off-Site
May 26 (Thursday)14:30~Off-Site
June 23 (Thursday)14:30~Off-Site
July 21 (Thursday)14:30~Off-Site
August 25 (Thursday)14:30~Off-Site
September 15 (Thursday)14:30~Off-Site
October 20 (Thursday)14:30~Off-Site
November 17 (Thursday)14:30~Off-Site
December 8 (Thursday)14:30~Off-Site

News

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.

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)

  • Voluntary Actions to a Direct Current Power Supply Unit (AC Adaptor) to be Taken by three Medical Device Industry Bodies EN [PDF]  |  JA [PDF]
  • Partial Amendment to the ‘Interpretation on Range, etc. of Elecgtrical Appliances and Materials (Outlines) EN [PDF]  |  JA [PDF]