Supervision Requirements of Medical Device Registration Standards in China
LI Bao-lin1, LI Bo-cheng2
1. Hebei Province Testing Institute for Medical Devices & Pharmaceutical Packaging, Shijiazhuang Hebei 050061, China;2. Hebei North University, Zhangjiakuo Hebei 075000, China
Abstract：This paper analyzed the requirements and status quo of medical device supervision standards and relevant documents in reverification, pre-evaluation, license validation, system examination and registration inspection of registered medical devices so as to explore the standardized management methods. As a consequence, more professionalized personnel and construction of a perfected supervision system ensured the security and effectiveness of medical devices.
李宝林，李博诚. 我国医疗器械注册产品标准监管要求[J]. 中国医疗设备, 2014, 29(2): 99-101.
LI Bao-lin, LI Bo-cheng. Supervision Requirements of Medical Device Registration Standards in China. China Medical Devices, 2014, 29(2): 99-101.
