Entrusted Test1. OverviewThe entrusted test can be resorted to when the testing purpose cannot be realized by self-test, The entrusted testing institution should have corresponding inspection ability. With respect to NMPA registration, the entrusted test can be considered as the pre-test of re
Biological EvaluationFor the medical device intended to be used for human body, firstly, qualitative analysis on the material used and analysis on existing data or relevant information are performed before the clinical trial. Then simulated in vitrobiological test is performed. The in vivo&nbs
Animal Experiment StudyThe animal experiment is an important part of preclinical study for medical devices and an important bridge connecting basic research and the clinical trial. Tt is expected to obtain new biological and medical knowledge or solve specific problems, and preliminarily verify the