The representative model of instruments for in vitro diagnostic reagents

The representative model of instruments forin vitro diagnostic（IVD） reagents simplifies the performance evaluation of registration. Different from the concept of the US FDA instrument family, the domestic identification of the representative model focuses on the risk analysis of instrument differences. However, there are problems such as unclear requirements for the identification of instruments, difficulties in the identification of new technology and high-risk instruments. The performance evaluation of the detection system can be partially simplified by representative models, and representative models can evaluate the performance of non-detection systems. Meanwhile, but the comprehensive performance should be evaluated by representative models as conditions.Therefore,according to the analysis performance evaluations using representative models can guarantee the safety and effectiveness of in vitro diagnostic reagents while promoting the high-quality development of the IVD industry.