Medical Equipment & Diagnostics Committee

News –

A representative meeting was held on December 10, 2020 (go to News section)

Medical Equipment

Healthcare in Japan is of a high standard with the country enjoying the highest average life expectancy and lowest infant mortality rates in the world. However, a number of inefficiencies in the system need to be addressed.

The EBC Medical Equipment Committee works closely with the Japanese Government, specifically the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), as well as the related industry associations to establish an environment that allows innovative European medical equipment to be delivered adequately to patients in Japan.

Medical Diagnostics

Medical diagnostic reagents and equipment are used to perform diagnostic tests in hospitals, commercial laboratories, physicians’ offices and blood banks.

Reagents are an essential component of any healthcare regime, indispensable in preventing sickness, detecting and diagnosing diseases, ascertaining the side effects of drug therapy, monitoring treatment, improving patient quality of life and decreasing total healthcare costs. Repeated cuts to reimbursement prices have reduced pricing levels in Japan below those of comparable overseas markets. The current regulatory structure and reimbursement regime constitute an obstacle to introducing new products the Japanese market and the committee aims to overcome these problems.

Upcoming committee meeting schedule

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

January 21 (Thursday)14:30~Off-Site
February 18 (Thursday)14:30~Off-Site
March 18 (Thursday)14:30~Off-Site
April 22 (Thursday)14:30~Off-Site
May 20 (Thursday)14:30~Off-Site
June 24 (Thursday)14:30~Off-Site
July 15 (Thursday)14:30~Off-Site
August 26 (Thursday)14:30~Off-Site
September 16 (Thursday)14:30~Off-Site
October 21 (Thursday)14:30~Off-Site
November 18 (Thursday)14:30~Off-Site
December 9 (Thursday)14:30~Off-Site


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]