After one year's work, the report of the EU-China Medical Device Expert Roundtable (MDER) was released on 20 January 2009. The Joint Working Group Report brought together input from over 20 leading European and Chinese experts from the medical device sector, including manufacturer, testing institutes, notified bodies and academia.
During the recent visit of the European Commission Directorate-General for Industry and Enterprise (DG ENTR) to China, the report was made available in Chinese and English to senior government officials from the China’s General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the State Food and Drug Administration (SFDA). Both agencies see the report as great opportunity to accelerate China's steps of developing a more scientific and sound regulatory framework which should be geared towards international harmonisation. Mr. Laurent Sellès from DG ENTR and member of the MDER Steering Group said, “I am very pleased with the outcome as the report contains the type of practical recommendations needed to stimulate the EU-China Dialogue”.
In 2007, at the initiative of Dr. Detlev Richter (COCIR) and under the co-leadership of Dr. Zhu Xuejun (CAMDI), the European Commission through its EU-China Trade Project (EUCTP) approved the funding for the MDER project. Over the course of 2008, a dedicated panel of experts authored a comprehensive report that compares and contrasts the European and Chinese regulatory framework and standards for medical devices. The final report contains over 30 concrete recommendations to both EU and Chinese regulatory bodies, providing a detailed roadmap to accelerate regulatory harmonization between EU and China.
Dr. Zhu Xuejun, Executive VP of CAMDI, and Mrs. Nicole Denjoy, Secretary General of COCIR, both confirmed the aim of MDER is to encourage better cooperation while increase the quality and safety of medical devices both in China and Europe.
For further information or an electronic copy of the report, please contact:
Europe: Mr. Maurizio Andreano
Technology and Regulatory Manager
Tel: +32 (0)2 706 89 62
E-mail: andreano@cocir.org
China: Ms. Yujie Bao
COCIR China Manager
Tel: +86 (10) 6462 2066
E-mail: ybao@euccc.com.cn
1 The 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.
2 The China Association for Medical Devices Industry (CAMDI):
CAMDI was founded in 1991 and is one of the first-class independent corporations registered with the Ministry of Civil Affairs of People’s Republic of China. It is an industrial and non for profit society which consists of companies and individuals engaged on manufacturing, distributing, R&D, testing and education training of medical devices on the basis of voluntary principle. There are 15 branches and professional committees supporting over 4, 000 membership companies of CAMDI. Its mission of is that of complying with state laws and regulations CAMDI represents common benefits of its members, safeguards the legal rights of members, and promotes constantly the safety and effectiveness of medical devices as well as the development of Chinese medical device.
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