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Regulatory Focus™ > News Articles > China Announces 17 New Device Classifications

China Announces 17 New Device Classifications

Posted 21 December 2012 | By Alexander Gaffney, RAC

China's State Food and Drug Administration (SFDA) issued a notice to the provinces and autonomous regions on 10 December 2012 announcing the classification of 17 medical devices based on expert advice provided to the SFDA.

Two products are to be regulated as Class III (high-risk) medical devices: an ultrasound tumor therapy system and a diagnostic imaging device for the skin. 

An ultrasound breast imaging diagnostic device and medical imaging software were among the ten products subjected to Class II (moderate risk) controls, and an ophthalmic surgery observation device was placed into a Class I (low risk) designation.  Four products, including a pure water processing system and a medical air cleanser, were exempted from regulation as medical devices. 


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