Abstract：Registration review of medical devices is the process to evaluate safety and effectiveness of premarket medical device
comprehensively. Based on the updated regulations for the supervision and management of medical devices, standards play an
indirect role in review through checklist of essential principles of safety and performance of medical devices, study data, product risk
analysis, product technical requirements, test report, user manual, labeling and other registration files. Meeting the requirement of
standards cannot assure safety and effectiveness of premarket medical device sufficiently. Standards cannot cover the whole picture
of medical device review. Learning from the application experience of standards in the US, EU and Japan, the correct understanding
the role of standards, reasonable and effective use of standards will help promote the efficiency of medical device review.
曹越，金若男，刘菁，陈敏，贺伟罡. 医疗器械标准在注册审评中的应用研究[J]. 中国医疗设备, 2020, 35(4): 159-162.
CAO Yue, JIN Ruonan, LIU Jing, CHEN Min, HE Weigang. Application Research of Medical Device Standards in Registration Review. China Medical Devices, 2020, 35(4): 159-162.
