Outline of JFMDA
JFMDA has been working actively for medical device industries through the Committees listed on page 5, which are managed by the JFMDA Board of Directors. In addition, JFMDA has officially been appointed to the national council for ISO/TC 210. Main current activities of the representative committees are as follows.
(1) Industrial Strategy Meeting
This Meeting deals with all types of important current issues related to JFMDA activities. Its members consist of directors of JFMDA Chair and Vice Chair companies.
(2) Materials/Devices Reimbursement Committees
These Committees study reimbursement programs related to medical devices and materials, representing industry opinions and making proposals to the government. It also handles medical waste management issues.
(3) Committees related to PAL (Pharmaceutical Affairs Law)
The Regulatory System Committee studies the PAL and other related laws and regulations, representing industry opinions and making proposals to the government. The QMS (Quality Management System) Committee seeks to establish a common framework for quality assurance systems to ensure the safety and effectiveness of medical devices and supplies; the Committee holds annual seminars and helps medical device industries improve their quality assurance systems. The GCP (Good Clinical Practices) Committee addresses issues related to the clinical investigation of medical devices and supplies, developing criteria based on ethical considerations and scientific accuracy and providing them to industries.
(4) The Technical Affairs Committee
The Technical Affairs Committee includes the EMC (Electro-Magnetic Compatibility), the Intellectual Properties and the GMDN (Global Medical Devices Nomenclature) Working Groups which deal with issues of immediate concern.
(5) Committees related to Global Affairs
The International Strategy Committee exchanges international information with other countries, holds international seminars, and conducts promotional activities. The GHTF (Global Harmonization Task Force) Domestic Committee addresses the issues of harmonized standards and regulations for medical devices and supplies. The GHTF Domestic Committee, which consists of Study Groups 1 to 5, discusses the feasibility of the global harmonization of regulatory affairs, participating in international meetings as a representative of the medical devices industries. The HBD (Harmonization by Doing) has started in 2006 by MHLW & FDA which activity is related to clinical practice, very close to GHTF SG5 and the GCP committee. The activities of ISO/TC 210 which consists of 6 working groups are taking a very important role to make JIS (Japanese Industrial Standards ) from ISO under the METI (Ministry of Economy, Trade and Industry).
(6) Corporate Business Ethics Committee & IT (Information Technology) Committee
The Corporate Business Ethics Committee seeks to establish a Promotion Code applicable to medical device industries. This Code defines the concept of appropriate gifts in order to maintain reasonable distribution systems. The IT Committee encourages the use of a bar-coding system applicable to medical device distributors. For more details, find "The Code of Ethics/The promotion Code" in our JFMDA Website.
(7) Public Relations Committee
This Committee provides relevant domestic and international information to related industries, publishes the quarterly JFMDA News Magazine, delivers the monthly JFMDA Fax News to supporting members. From 2006 "Citizen Forum"has been held annually by JFMDA and METIS (Medical Engineering Technology Industrial Strategy Consortium) supported by MHLW, METI and MEXT (Ministry of Education, Culture, Sports, Science and Technology). METIS aims at the innovation of new medical devices through the cooperation with government, scholars and industry. For more details, find "METIS" in our JFMDA Website.
