Abstract：This article compared the standard requirements of self-test blood glucose monitoring system in China, the United States
and the European Union from the perspective of medical device registration review, and analyzed the trend of systematic regulatory
risk change of this product base one the status of the product’s registration, as well as the latest technology trends and registration
review issues.The article also discussed and gave the supervision suggestions for the independent software, microfluidics, multiparameter
testing and other problems that have emerged in the product registration process. This provides technical reference for
product research and development production in this field, as well as review and approval and post-marketing supervision.
叶朝付a，杨笑鹤a，曾叶b，寇艳芹a，王宇航a. 自测用血糖监测系统注册审评的探讨与监管建议[J]. 中国医疗设备, 2022, 37(4): 113-116.
YE Chaofua, YANG Xiaohea, ZENG Yeb, KOU Yanqina, WANG Yuhanga. Discussion and Suggestion on Registration and Evaluation of
Blood Glucose Monitoring System for Self-Testing. China Medical Devices, 2022, 37(4): 113-116.
