[Discussion on Technical Evaluation of Enzyme Electrode Biosensor Blood Glucose Meter].

Enzyme electrode biosensor blood glucose detector is a new rapid blood glucose measurement method. There is no corresponding product standard and industry standard reference at home and abroad, and there is a lack of corresponding reference experience in performance research and clinical evaluation. This study discusses the safety and effectiveness of enzyme electrode biosensor blood glucose detector from the perspective of technical evaluation of medical devices. It is expected to provide some reference for medical device registration technical reviewers and registration application enterprises.