Activities

IVD（In Vitro Diagnostic）Instrument Committee

IVD Instrument Committee promotes the following issues on behalf of IVD instrument manufacturers.

To study and research related to IVD Medical Device (Clinical instrument).
To provide information on product safety and occupational safety and health.
To deal with Japanese product regulations and foreign product regulations.

Subcommittees

PMD Act (Pharmaceutical and Medical Device Act) Subcommittee

PMD Act Subcommittee promotes the following issues to secure the quality, effectiveness and safety of IVD-MD, and to have common knowledge of Japanese regulations such as PMD Act.

To provide information to the membership companies and to promote research etc.
To participate in the related committees such as Regulations, QMS, PMS and UDI of JFMDA (The Japan Federation of Medical Devices Associations ).
To reflect our opinions through exchanging the information and proposals with/to government authorities and other industrial organizations.

Standardization Subcommittee

Standardization Subcommittee promotes the following activities by cooperating with the Japan Medical Association (JMA), Japanese Association of Medical Technologists (JAMT), and Japan Registered Clinical Laboratories (JRCLA) etc. to support the external quality control project of the national level.

To revise the code table of the IVD instruments.
To publish the latest code table on the JAIMA homepage.

Safety, EMC Standardization Subcommittee

Safety, EMC standardization Committee promotes the following issues for the expansion of IVD clinical instruments through joining the international committee for standardization.

To address common issues about safety and EMC.
To contribute to improve the international competitiveness of Japan's IVD-MD industry.
To interact across foreign industry associations.
To improve the status of IVD-MD in medical industry.

IVD International Subcommittee

IVD International Subcommittee promotes the following activities to support the global activity of membership companies of IVD Instruments Committee.

To research the regulations and industrial information of IVDs of foreign countries.
To participate in the related committees such as International Policy & Strategy Committee and its subcommittees in JFMDA (The Japan Federation of Medical Devices Associations).
To participate in GDA (Global Diagnostics Alliance) composed of IVD industrial associations in US, EU, Canada, Brazil, Australia, and Japan (JACRI, JAIMA) for exchanging information and having a discussion about IVD related issues.
To participate in IVD 3 associations' united WG for researching the regulations and industrial information of IVDs in Asian countries.

IVD for Veterinary Subcommittee

IVD for Veterinary Subcommittee promotes the following activities to achieve deregulation of IVD products for veterinary and a proper market offer. (Background: In Japan, the manufacturers of medical device for veterinary have to get the manufacturing license and the pre-market approval as well as the one for human.)

To exchange information and opinion with regulatory authority (Ministry of Agriculture, Forestry and Fisheries) and related industry groups.
To hold seminars about the regulations for IVD instruments for veterinary.

The Japan Fair Trade Council of the Medical Devices Industry, JAIMA

Japan Analytical Instruments Manufactures' Association (JAIMA), an organization under The Japan Fair Trade Council of the Medical Devices Industry (JFTC), aims to lead fair trading of analytical instruments to medical institutions as well as to provide the latest information to the associated companies.

JAIMA's wide-ranged activities include monitoring, offering guidance to and promoting awareness of the associated companies based on the principles of the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade, the Unfair Competition Prevention Act, and the Act against Unjustifiable Premiums and Misleading Representations.

Japan Council for IVD-MD (In Vitro Diagnostic Medical Device)

Japan Council for IVD-MD, which consists of JACRI (Japan Association of Clinical Reagents Industries) and IVD Instrument Committee of JAIMA, aims expansion of In Vitro Diagnostic (clinical reagent and clinical instrument). Its activities include tackling common issues that concern Japanese product regulations and foreign product regulations, bolstering the international competitiveness of Japan's IVD-MD industry, interacting with foreign industry associations and, raising the status of IVD-MD in medical industry.

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