Regulatory Science for Proficiency Testing System of Medical Devices in China
Objective:To study the value mechanism of capability verification for medical devices regulatory science.Methods:Based on the development history of regulatory science,the development status and important enlightenment of China's medical device capability verification system construction were briefly described.Results and Conclusion:The construction of a capability verification system was an important means of quality control for medical device inspection and testing,which provided scientific technical and data support for its safety supervision and risk assessment.Based on the scientific perspective of medical device regulation,combined with the idea of promoting the integrated development of national quality infrastructure through capacity verification,the value and role of capacity verification impact mechanisms are proposed for reference by relevant institutions and industry personnel.
capability verificationregulatory scienceinspection and testingmechanism of actionsystem construction
NETL
NSTL
万方数据
