Research On Current Situation And Improvement Of Risk Management For Medical Device Laws & Regulations In China

Objective: To analyse the laws and regulations in medical device depend on the risk management, search for the problems for the improvement and the development of risk management of medical devices, strengthen the risk management of medical device, maintain and ensure the rights and interests of public health.Method: The methods of evidence based on literature were used to define the five particularities of risk management for medical device ,the risks and risk management for medical device, and systematically study the laws and regulations system of medical device with risk management theory, and analyse the current Chinese monitoring policy in all process steps from pre-marketing to post- marketing of medical device.Result: China has established the monitoring system for medical device with the focus of authorization before marketing, monitoring and alert post marketing, and the monitoring of manufacturing sites at the 4 levels in national, provincial, municipal and prefectural, the monitoring system including professional, individual multi-purpose technical supporting system, the adverse event reporting system. The result showed that the pre-marketing risk management laws and regulations have reached the international standard, however the post-marketing regulations were still weak ,compared with those in developed countries. The nine problems in the post-marketing management regulations of medical device were suggested.Conclusion: China has established: the monitoring system for medical device ,but the laws and regulations in pre-marketing risk management and the post-marketing risk management must still be improved in the future.