Research on the Construction of Modern Governance System of Medical Devices in China
The development of new productivity urgently calls for the establishment of a modern governance system.Aiming at the core issues of medical device safety governance in China,this paper explores the construction of a modernization governance system for medical devices in line with China's national conditions from the aspects of value goals,governance frameworks,and implementation paths.Based on both domestic and international governance theories and the current regulatory status of China's medical device industry,the paper suggests a reassessment of the original goal of"safety and efficacy",while proposing the timely establishment of new goals of"availability and accessibility".The modernization of China's medical device governance framework should be reconstructed through fostering a diversified social governance model,building cross-departmental collaborative governance mechanisms,and promoting the development of professional regulatory expertise.Besides,the implementation path to optimize the governance system is discussed from the perspectives of legalization,scientization,digitization,and internationalization.
medical devicesmodernizationgovernance systemsocial co-governance
万方数据
维普
