FDAnews Device Daily Bulletin

China Classifies 17 Devices

Jan. 16, 2013
China’s State Food and Drug Administration has newly classified 17 devices as part of an effort to align its device classification system more closely with international standards. Ultrasound tumor therapy systems and skin microscopy image diagnostic apparati are now considered Class III devices. Newly designated Class II devices include pressure distribution measurement pads, fluorescence imaging and graphic reporting software, cochlear signal converters and contrast sensitivity analyzers.
International Medical Device Regulatory Monitor