JIRA Activity Report

International Division

The JIRA International Division is proceeding with investigations on Asia, in particular on regulations of medical devices and market information of China and Korea. The Division reports the results in detail to the JIRA members by means of news bulletins and activity-report sessions.

(1)Major investigation activities concerning China

(1)Investigation on the revision of China Medical Devices Administration Ordinance

(2)New China Compulsory Certification Scheme (CCC mark)

(3)Intensive Purchase System for Medical Devices

(4)Information on the Chinese Market of Medical Devices

(5)Chinese RoHS regulations

(6)Administrative Measures on Examination and Supervision of Imported Medical Devices (Decree 95)

(7)Health Insurance System and others

(1)-1Related Chinese Organization that JIRA has contacted for the purpose of investigation activities

(1)International Health Exchange and Cooperation Center, Ministry of Health, P.R. China (MOH)

(2)State Food & Drug Administration (SFDA)

(3)Certification and Accreditation Administration of the P.R. China (CNCA)

(4)China Quantity Certification Center (CQC)

(5)Liaoning Medical Device Quality Supervision and Test Institute

(6)China Association for Medical Devices Industry (CAMDI)

(7)NEMA Beijing Office

(8)Embassy of Japan in China

（Meeting with International Health Exchange Center staff）

(2)Major investigation activities concerning Korea

Korean government has been engaged in the revision of the Korean Medical Equipment Law and in review or addition of bylaws since 2006. The JIRA International Division has been investigating them. In addition, JIRA has been actively contacting the Korean government year by year. From the latter half of 2006 to 2007, the Korean administrators and other officers of concern visited JIRA several times for information exchange.

(2) -1Description of investigation activities for Korea

(1)Investigation on the Korean Medical Equipment Law

(2)Information on the Korean Market of Medical Devices

(3)Environmental regulations and software-related issues and others

(2)-2 Related Korean Organization which JIRA has contacted for the purpose of investigation activities

(1)Korea Food and Drug Administration (KFDA)

(2)Korea Testing Laboratory (KTL)

(3)Korea Medical Devices Industry Association (KMDIA)

(4)Korea Medical Devices Industrial Coop. Association (KMDICA)

（Meeting with Korean KFDA staff)

To support the JIRA Related Apparatus and Accesory Division, the International Division supports member companies wishing to expand into China in exhibitions/shows. In 2007, in particular, JIRA exhibited products and catalogs of the JIRA member companies and introduced JIRA at the following exhibitions:

China International Medical Equipment Fair (Spring Exhibition) held in Dalian in April
CHINA-HOSPEQ 2007 organized by MOH in Beijing in September
China International Medical Equipment Fair (Fall Exhibition) held in Chengdu in October

（China International Medical Equipment Fair (Fall Exhibition) held in Chengdu (at JIRA booth)

(4)DITTA meetings

JIRA participated in the General Assembly and TC meetings of DITTA (consisting of four associations; COCIR, NEMA, EFC and JIRA) during the RSNA 2007. At the General Assembly, DITTA members discussed aboutthe global tendency of the medical device market, China-related issues, international harmonization of regulations and environmental regulations. JIRA is involved in various international activities, trying to achieve harmonization with other DITTA members.

(5)GHTF activities

The activities aiming at global harmonization is an important function in the industry. GHTF(Global Harmonization Task Force) is comprised of public-welfare administrative departments and industry organizations of U.S.A., Canada, Australia, European Union (EU) and Japan. It is engaged in harmonization of regulations and offers support to the countries that have not implemented medical-device regulations yet. Its major goal is to ensure "Approved Once, Accepted Everywhere.” i.e., once a product is approved by one country, it is to be smoothly accepted and placed on the market in any other countries.

In the broader field of medical devices, JIRA mainly handles diagnostic imaging systems such as radiological equipment and related system devices, and plays a large role in terms of the harmonization of regulations imposed on those items.GHTF has five different study groups such as; (1) Pre-market Evaluation, (2) Post-market Surveillance/Vigilance, (3) Quality System, (4) Auditing method, and (5) Clinical Test. In addition, it has a sub-study group covering software. Activities conducted by GHTF are highly correlated with the Japanese Pharmaceutical Affairs Law, and consequently, guidance documents prepared by GHTF are to be the framework for regulations imposed on medical devices toward the future. Matters related to the documents such as materials needed for the premarket approval are important issues in terms of the achievement of international harmonization including conformity evaluation, represented by the sloganized goal "Approved Once, Accepted Everywhere." Harmonization of auditing methods also falls under the same slogan from the viewpoint of the manufacturers, which globally supply products. JIRA participates in the meetings in a positive manner and dispatches committee members.

(6)AHWP activities

Not only the GHTF founding countries but also others require to harmonize their national regulations to the global standard. In Asia, China and other ASEAN countries have participated in AHWP (Asian Harmonization Working Party), and AHWP is working based on the GHTF documents, aiming at harmonization in medical device regulations in the Asian region. The GHTF founding members support the activities of the Asian countries as one of their tasks. JIRA is in charge of providing explanations about the GHTF documents that describe the premarket evaluation and post-market surveillance/vigilance as well as the current situation of Japan. In the Asian zone, some countries have already implemented medical device regulations and others have not. It is therefore necessary to carry out harmonization work under the aforementioned situation with implementation level differences. If Japanese companies try to export their products to an Asian country or subcontract manufacture of their products to a manufacturer of the country and import the finished products, it would be quite effective for the Japanese industries when the country has medical device regulations which are same with or similar to those of Japan in terms of efficiency. It would be of course more effective when medical device regulations are harmonized not only in the Asian zone but also in the other zones of the world. JIRA is involved in activities taking in account the promotion of efficient trading toward the future.

(7) RSNA tour planning

The JIRA International Division annually organizes a tour to RSNA for the member companies. JIRA arranges the flight tickets and hotel rooms in one of high seasons in Chicago and register for the RSNA exhibition to support the member company staffs that are not familiar with overseas business trips.

Global standardization activities

(1) ISO Standards

In the revision of the Japan's Pharmaceutical Affairs Law (enacted on the 1st of April, 2005), the policy to adopt specifications defined by international standards as JIS(Japan Industrial Standard) in premarket approval procedures has been included. Following the policy, the JIS Drafting Committee (JIRA Standard Committee) planned to conduct joint investigation with other JIS standardization committees. When Pharmaceuticals and Medical Devices Agency was newly founded, a Standards Division was set up to enable the Agency to continuously participate in international meetings organized by ISO (International Organization for Standardization) or other organizations as a regulator. The JIRA International Division is supporting activities aiming at global harmonization of medical device regulations from the standpoint of the industry. It is also involved in gathering of information on ISO together with other Divisions of JIRA.

In addition, the JIRA Medical Imaging System Division is involved in standardization activities regarding the security of the medical information system. In 2007, jointly with Japanese Association of Healthcare Information Systems Industry (JAHIS), JIRA made a proposal to adopt "Remote Service Security Guideline" established by JESRA as an ISO Technical Report.

(2) IEC Standardization Activities

IEC (International Electrotechnical Commission) is an international organization for developing international industrial standards in areas related to electrical technology. JIRA has been commissioned by Japanese Industrial Standards Committee (JISC) to become a Japanese national committee for IEC. JIRA, therefore, participates in following two sub-committees to conduct deliberations regarding international standards and standardization activities:

1)SC-62B (SC: Sub-Committee)

A technical sub-committee which is responsible for development and deliberation of international standards regarding manufacture, installation and use of diagnostic imaging equipment included in the category of electrical equipment in medical practice.

2)SC-62C

A technical sub-committee which is responsible for development and deliberation of international standards regarding manufacture, installation and use of equipment for radiotherapy, nuclear medicine and radiation dosimetry included in the category of electrical equipment in medical practice.
Working groups are organized in the aforementioned two sub-committees on a device-by-device basis such as CT and nuclear medicine. JIRA participates in lots of the working groups in a positive manner.
Meetings of those working groups are mainly held in Europe and USA as international conferences. In 2007, totally 23 members from the JIRA Standardization Division attended 12 meetings as representatives from Japan.
Furthermore, when an IEC standard is established or revised, JIRA works as a deliberative body for JIS to develop a JIS draft which harmonizes with the IEC standard in cooperation with Japanese Standards Association.

(3)DICOM

DICOM (Digital Imaging and Communication in Medicine) standards are industrial standards in medical imaging. JIRA acts as a liaison for DICOM in Japan. JIRA carries out the following international activities:

1. Participation in general meetings of the DICOM Standard Committee (DSC)
2. Regular attendance in meetings of WG6, which is in charge of administrationand deliberation of new standards
3. There is a proposal of a draft DICOM standard (CoDP) concerning communication of information on monitors. JIRA is making efforts to reflect Japan's opinions in the draft. In 2007, totally 18 members mainly from the DICOM Committee and Softcopy Display System Committee of the Medical Imaging System Division have attended eight international meetings held in various countries.

(4)SPC

SPC (Joint Security and Privacy Committee) has been founded by NEMA/MITA*1, COCIR*2 and JIRA which are industrial associations respectively of U.S.A., Europe and Japan aiming at the establishment of common guidelines for handling the private information protection laws applicable to medical imaging field. The SPC has developed many white books. The JIRA Medical Imaging System Division participates in the SPC activities.

*1NEMA・MITA＝National Electrical Manufacturers Association, Medical Imaging and Technology Alliance
*2COCIR＝European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industries.