First Joint EU-China Initiative Moves Towards Electromedical Safety Standardisation

Shanghai, 5 March, 2009.  Experts from world-renowned testing labs, leading medical device manufacturers and standardisation organisations and authorities met in Shanghai on 24-25 February to discuss how to align their understanding of international standards for medical electrical equipment safety. The conference on GB 9706.1-2007/IEC 60601-1 was organised by the Shanghai Testing and Inspection Institute for Medical Devices (CMTC) and the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR). Approximately 120 participants attended the two-day conference.

“The most urgent task of China’s standardisation work is to establish a regulatory framework that is comprehensive, scientific, unified and authoritative and to adopt international standards which is key to people’s welfare. They are also helpful in promoting China’s innovation speed, international competitiveness and export expansion.” said Mrs Ge Meijun, Deputy Director General of Shanghai Food and Drug Administration (SH FDA) during her opening remark at the seminar.
The GB 9706.1-2007, equivalent to the 2nd edition of the IEC 60601-1 international standard on medical electrical equipment safety, went into effect in China in July 2008. Intended as a platform, the conference provided experts with an opportunity to exchange their views on relevant issues on the standard’s implementation. The event also included an overview of the 3rd edition of the IEC 60601-1 international standard.

“COCIR has always promoted the use of international standards across borders and is happy to support CMTC in the enforcement of international standards in China”, said Dr. Davey Han, COCIR’s China Chairman. Director Huang Jiahua from CMTC echoed the purpose of this conference, “This event aims to help us align our interpretation of GB9706.1 with a common international understanding. I believe it will project a positive influence on international trade and the development of the medical device industry”.  The conference was very well received by the participants who encouraged the organisers to further promote this type of practical and constructive approach.

For further information, please contact:
Europe: Mr. Maurizio Andreano
Technology and Regulatory Manager
Tel: +32 (0)2 706 89 62
China: Ms. Yujie Bao
COCIR China Manager
Tel: +86 (10) 6462 2066

1) Shanghai Testing & Inspection Institute for Medical Devices (CMTC)
Shanghai Testing & Inspection Institute for Medical Devices, respectively audited and approved by China National Accreditation Committee for Laboratories, State Food and Drug Administration and other related authorities, is a state-level quality supervision and inspection body for medical products. It has designated laboratory for accreditation testing for medical products, as well as the technical supporting unit directly affiliated to Shanghai Food and Drug Administration. The institute boasts of more than 600 sets of testing instruments of various types as well as equipment for environmental test. Based on strong technical capability and high-quality equipment, tests for various types of medical products are effectively fulfilled within its authorized business scope.

2) European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR)
COCIR has been the voice of the healthcare and medical IT industry in the European Union since 1959 and is working to develop the future of healthcare in Europe and beyond.  COCIR, based in Brussels, represents the interests and activities of its members, global companies and SMEs as well as national trade associations, and acts as a channel for communication between all its members and the European institutions and other global regulatory bodies. It promotes free worldwide trade of medical devices and encourages the use of advanced technology supporting cost-efficient healthcare delivery worldwide. COCIR represents more than 50 000 employees in Europe and generates a business of more than 40 Billion Euros. In 2007, COCIR set up a China Desk to facilitate stronger communications between its members and relevant Chinese regulatory bodies and institutions.

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Kathryn Sheridan
COCIR Communications Advisor
00 32 (0) 496 116198