Regulation and Safety Division

Outline

In order to market JIRA products and ensure safety under proper laws and regulations, this division investigates and examines the laws and regulations relevant to medical equipment and submits proposals to the government while providing information to member companies. The division also conducts activities related to environmental regulations on medical equipment in order to help develop this industry and elevate its status.

Main activities

  • Research, examination, and popularization of domestic and foreign regulatory systems related to medical equipment
  • Examination of regulations related to safety and quality systems
  • Exchange of opinions and cooperation with related academic societies and organizations
  • Research on trends in international environmental regulation on medical equipment

Organization

  • Regulation and Safety Division Main Committee
    • Regulation Committee
      • Expert Committee on Development of Certification Criteria
      • Expert Committee on Medical Equipment for Animals
      • Expert Committee on Radiotherapy Planning Program
      • Expert Committee on International Regulations on Medical Equipment
      • Expert Committee on QMS
    • Safety Committee
      • Expert Committee on Post-Marketing Safety Management
      • Expert Committee on Guideline Development
    • Environment Committee

Main activities

Main Committee
 This committee organizes committees and working groups required to complete the following operations of the division. It also conducts deliberations necessary for those operations and makes proposals to higher institutions.
1. Development and implementation of annual business plans
2. Active participation in and cooperation with the government administration
3. Development and implementation of measures required to secure medical equipment safety
4. Study and popularization of related regulatory systems
5. Communication with related industries
6. Other operations necessary to fulfill the objectives of the division

Regulation Committee
This committee studies laws that play an essential role when members conducting their operations (such as the Pharmaceutical Affairs Act, the Medical Service Act, and the Law Concerning Prevention from Radiation Hazards due to Radioisotopes, etc.) and other regulations and gathers opinions from members to approach the government.

Safety Committee
In order to ensure the safety of medical equipment in use, this committee studies administrative regulations, such as defect reporting and collection systems, develops guidelines to provide accurate information, and engages in cooperation and negotiations with the government.

Environment Committee
The Environment Committee promotes industry-wide environmental efforts, such as measures against global warming, while collecting and disseminating information on environmental regulations that affect the sale of medical equipment at home and abroad.
1. Collects and disseminates information on international environmental regulations that affects the export of medical equipment such as European regulations on chemical substances (RoHS, REACH).
2. Exchanges information with the Japanese government and industry associations related to RoHS categories 8 and 9 and summarizes and delivers Japan’s opinions.
3. Conducts a survey on the amount of greenhouse gas emissions on a continuous basis in cooperation with the Environmental Committee of the Japan Federation of Medical Devices Association.