Classification and Management Status of Rehabilitation Medical Devices in Domestic and Overseas
WANG Yue1, ZHANG Chunqing1, WANG Yue1, GAN Ning2 , RONG Shankui1, JIANG Xiao1, JI Xiongfei2 , YU Xinhua1
1. Institutes of Medical Device Standardization Administration, National Institutes for Food and Drug Control, Bejing 100050, China;
2. National Center of Standards Evaluation, SAMR, Bejing 100088, China
Abstract：To explore the classification technology of rehabilitation medical devices, from the perspective of classified management
of medical devices, this paper studied the supervision of rehabilitation medical devices in the United States, European Union, Japan
and South Korea by combing the classification principles and catalogs of medical devices. This paper analyzed the management of
rehabilitation medical devices in China, explored and put forward the classification ideas of medical rehabilitation devices, in order to
provide reference for the classification technology of rehabilitation medical devices.
王越1，张春青1，王悦1 ，甘宁2 ，戎善奎1，江潇1，计雄飞2，余新华1. 国内外医用康复器械分类与管理现状[J]. 中国医疗设备, 2022, 37(3): 163-166.
WANG Yue1, ZHANG Chunqing1, WANG Yue1, GAN Ning2 , RONG Shankui1, JIANG Xiao1, JI Xiongfei2 , YU Xinhua1. Classification and Management Status of Rehabilitation Medical Devices in Domestic and Overseas. China Medical Devices, 2022, 37(3): 163-166.
