Message

Takayoshi Mimura

Chairman
Medical Technology Association of Japan

The environment surrounding the medical device industry has been changing drastically.

The first thing we need to highlight is that many new technologies have been applied to the medical field in recent years. Technologies, including AI and IoT, will bring new effects and values beyond the conventional concept of medical devices. New opportunities to develop medical devices also lie in fields such as cell therapy and regenerative medicine. In addition, in the pharmaceutical field, medical device technologies have been drawing much attention to the improvement of treatment adherence, on top of biotechnologies and genomic drug discovery technologies. In this way, new business opportunities for medical devices are expanding beyond the conventional boundaries. We are dedicated to contributing to global healthcare through innovation by incorporating new technologies from different fields and industries, not just staying in the existing industrial framework.

Another movement we must address is globalization. Japan’s GDP at the start of the Heisei era (1989) was equivalent to 15% of the world’s GDP, and has now fallen to 6%. Japan is also confronted with many issues such as declining birthrate and aging population. Promoting globalization is inevitable for us, as Japan faces depopulation. In order to promote further globalization, we will continue to corporate with international administrative agencies and related authorities to align our regulation to other countries.

The medical device industry today gains substantial expectation from society and our responsibility is heavier than ever before. We strive for the improvement of quality and efficiency of medical treatment globally through the development of superior medical devices. Furthermore, we declare to fulfill our social responsibility for stable supply by reinforcing our capabilities including recovery assistance of natural disaster that frequently occurs. I sincerely appreciate the continued understanding and generous cooperation from all parties.

Overview

Promptly providing safe and innovative medical technology Contributing to improved medical quality and the development of the medical device technology industry

Summary

Medical Technology Association of Japan
【Regular members】 253 companies
【Associate members】 45 companies
【Number of employees】
Japan:Approx. 73,000
Outside Japan: Approx. 70,000

As of June 2019

History

1967:
Medical Plastics Conference established. 1990:Name changed to Japan Association of Medical and Material Industries (JAMMI)
1979:
Japan Artificial Organ Industry Association (JAOIA) established
2000:
JAMMI and JAOIA merged. Japan Medical Devices Manufactures Association (JMED) launched
2013:
Reorganized as Medical Technology Association of Japan (MTJAPAN)

Composition of Domestic Shipment for MTJAPAN products

Source: MTJAPAN FY2016 statistical data

Organization

Source: MTJAPAN FY2016 statistical data

Activity

Development of business from R&D to post-commercialization and international expansion

  • To maintain the effectiveness and safety of medical devices
  • Maintaining stable supply

Source: MTJAPAN FY2016 statistical data

Business for member companies

  • New administration and industry trends declarations
  • Hosting of training seminars and lectures, etc., for members only
  • Presenting opportunities to configure networks with the industry and government, etc.
  • Proposing corporate requirements to government as a voice for the industry
  • Other businesses for members
    Publishing MTJAPAN news, and compiling MTJAPAN medical device statistical data Operating medical technology matching sites and seminars Introducing MTJAPAN group insurance (product liability insurance both in Japan and other countries) Assuring stable supplies during a disaster

Announcing government and industry trends

We periodically distribute notices from the government and offices on the MTJAPAN members website.

ISO/TC meeting

Website top page

Lectures and seminars

We organize lectures and seminars on the latest regulatory trends and business and employee training for companies.

  • Lecture on medical insurance system
  • Lecture on medical device regulations
  • Lecture on clinical evaluation system
  • Lecture on QMS compliance survey
  • Lecture on trends in international standards
  • Medical device technology matching seminar
  • Overseas business expansion seminar
  • Medical device distribution seminar
  • Environmental regulation seminar
  • Public relations seminar
  • Post market surveillance workshop
  • Corporate ethics education workshop
  • Continuous training for selling and repairing medical devices*
    (*Held in the capacity of a Ministry of Health, Labour and Welfare registered organization)
Continuous sales and repair training

Continuous sales and repair training

Public relations seminar

Public relations seminar

General meeting

General meeting

Domestic and foreign networking

We provide networking opportunities with the medical device industry and government through employee general meetings/gatherings, New Year's gatherings, committees, and group activities.
We create global networks. Our activities include sending representatives to international conferences like AdvaMed, APACMED and AHWP, as well as hosting medical device symposiums and booth exhibitions at CHINA-HOSPEQ.

MTJAPAN exhibition booth

MTJAPAN exhibition booth

Announcing policy proposals

Through committee activities, we announce policy proposals following discussions and meetings with the Japan Federation of Medical Devices Associations (JFMDA) and the government regarding policies concerning industrial development, health insurance systems, laws and regulations, and standards.

Gathering details

Gathering details

Participation in setting ISO and JIS standards

As the Japanese consultative body for the technical committee of four ISO fields, we send representatives to international conferences and participate in setting international standards.

  • ISO/TC76 (Blood transfusion and infusion equipment, etc.)
  • ISO/TC84 (Injection equipment, etc.)
  • ISO/TC150 (Artificial lungs, surgical implant devices, etc.)
  • ISO/TC194 (Biological safety evaluations for medical devices)

We have participated in establishing approx. 80 JIS standards concerning our organization's products.

ISO/TC84 Tokyo Conference

ISO/TC84 Tokyo Conference

Publishing printed materials

We edit and publish materials concerning medical devices.We also introduce activities statuses and data through our website.

  • Special Insurance Medical Materials Guidebook
    Posting use objectives, methods, fees, and redemption prices, etc., for special insurance medical materials
  • Introduction to plastic medical devices
    Posting plastic materials and characteristics for sterilization devices
  • MTJAPAN medical devices statistical data
    Posting market and industry trends within the scope of our organization
  • MTJAPAN news (website)
    Introducing activities statuses for our organization
  • Medical device past and present stories (website)
    Introducing the history of various medical devices
Gathering details

Special Insurance Medical Materials Guidebook

MTJAPAN medical devices statistical data

MTJAPAN medical devices
statistical data

Matching site operations

We operate a matching site on our website as a forum for meeting MTJAPAN member companies, companies in different fields, the academic society and other organizations. Member companies can browse information including products and technologies registered by companies in other fields and use the information to introduce new technologies needed to differentiate their products. We offer opportunities for companies in other fields to enter the medical device industry.

https:www.mtjapan.or.jp/jp/matching/
Matching website

Matching website