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Regulatory Focus™ > News Articles > China Recognizes Device Electromagnetic Testing Centers

China Recognizes Device Electromagnetic Testing Centers

Posted 18 March 2013 | By Louise Zornoza

In December 2012, China's State Food and Drug Administration's (SFDA) National Medical Standardization Technical Committee issued a standard (YY 0505-2012) that is equivalent to the international electromagnetic compatibility testing standard (IEC 60601-1-2), with an effective date of 1 January 2014.

To date, the SFDA says it has recognized a number of medical device testing institutions that are qualified to carry out the detection of electromagnetic compatibility of medical electrical equipment in accordance with the new standard.  Notably, the agency has recognized the testing centers in Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou, Wuhan, Jiangsu Province, and Shenzhen among others. 

 

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