Abstract: Objective To modify the monitoring process and means of adverse events in vitro diagnostic reagents,improve the quantity and quality of adverse events reported in vitro,and reduce the workload of regulatory authorities,eventually ensure the safety and effectiveness of in vitro diagnostic reagents.Methods The pre-filtering risk assessment system based on BP neural network was used to evaluate the adverse events of in vitro diagnostic reagents.According to the evaluation results,the administrative supervision departments took corresponding countermeasures.Results The BP neural network learned the historical data,and the risk evaluation results of the adverse events were basically consistent with the expert group.Conclusion BP neural network can be used to evaluate the risk of adverse events and achieve risk signal aggregation of adverse events.