医疗器械标准化技术委员会国内外对比研究OACHSSCD

By studying the construction of standardization technical committees on medical devices in ISO,IEC and China,this paper sorts out the corresponding relationship of Chinese standardization technical committees on medical devices and those in ISO and IEC,and conducts a comparative analysis from the technological perspective,which finds that the gap in setting standardization technical committees for medical devices between China and international organizations has been gradually reduced,with China even leading international partners in some fields.According to the current situation of standards system for medical devices in our country,the paper puts forward suggestions to further improve China's standardization of medical devices.