SHANGHAI, April 2, 2014 /CNW/ - The Chinese government on Monday unveiled a new regulation on the supervision of medical equipment in a bid to enhance its safety and effectiveness and safeguard public health. The regulation will come into effect on June 1.
Under the new rule, medical equipment in China will be registered and divided into three categories based on the potential health risks they might pose for the public. High-risk equipment will be placed under stricter control by the authorities, it said. Those who manufacture or operate unregistered high-risk medical equipment, or manufacture or operate it without official endorsement will have their illegal gains and production apparatus and materials confiscated, and could face fines up to 20 times as much as the value of the equipment, as well as criminal charges, the regulation said.
BioDevice 2014 is to be held on 28-29 May in Shanghai, China. At the summit:
Feng Lin, Director of Division of Medical Devices Registration, Shanghai Food and Drug Administration will PROVIDE CLARITY to new regulation on the supervision of medical equipment and EXPLAIN how to get market approval for medical device in China.
Yutao Hua, Director of Center of Chemical Medicine and Medical Devices, Ministry of Science and Technology will ANALYZE status-quo and development trends of medical device industry and COMPREHEND how government will support the development of innovative medical device technology.
Aiguo Wang, Chairman and General Manager, Trauson Medical Instrument (Stryker) will REVIEW the pioneering developments in 3D printing and DISCUSS how 3D Printing will transform medical device concept designs and manufacturing.
Jay Qin, Founder and Chairman, Shanghai Kinetic Medical will SHARE his views on product development and commercialization of implantable and interventional medical devices and they can be key driver of business growth.
Zhonghua Li, Executive Vice General Manager, Microport Endovascular Medical will GIVE an update on minimally invasive treatment of peripheral vascular disease of and EXPLORE their outlooks.
The Boston Consulting Group, OrbiMed Asia and Northern Light Venture Capital (NLVC) will start some lively panel discussion on Investment and M&A Opportunities in Medical Device Industry.
For more information, please visit our website www.biodevicesummit.com
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SOURCE: UBM China
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