SFDA drew 6 technical guidelines of medical device registration Go back »

2009-05-05 | Beijing, Shanghai

HCE Working Group Members
News Update: SFDA drew 6 technical guidelines of medical device registration
 
 
Dear Working Group Members:
 
Please find the latest policy update attached below for your reference,

In order to enhance the supervision and the direction of medical device registration, improve registration level and review quality, State Food and Drug Administration (SFDA) drew 6 technical guidelines of medical device registration, including X-ray diagnostic equipments (Class II), orthopedic external fixation support, trachea cannula, disposable aseptic catheter, canales ventriculi, and electrocardiograph.

The guidelines were issued in March 2009.

Link to the news in English: http://eng.sfda.gov.cn/cmsweb/webportal/W43879541/A64030131.html

Link to the news in Chinese: http://www.sda.gov.cn/WS01/CL0055/37499.html

***************************************************************

For any further information about the Healthcare Equipment Working Group, general inquiries such as Membership with the European Chamber or our partner associations, please contact Ms. Yujie Bao (for COCIR ) at ybao@euccc.com.cn or Ms. Penny Zhao (for Eucomed ) at yzhao@euccc.com.cn