Reflections on Establishing a Medical Device Vigilance System in China Based on Post-Market Regulatory Requirements in the United States and European Union
This paper aims to explore the post-market regulatory systems for medical devices in the United States and the European Union,including risk regulatory concepts,regulatory legal systems,post-market clinical studies,quality management systems.It summarizes the experiences of developing risk monitoring tools,implementing risk management,merging reporting models,disclosing risk information.The aim is to provide insights and references for the systematic development of China's medical device industry.China can learn from the post-market regulatory practices of medical devices in the United States and the European Union to establish and pilot a robust medical device vigilance system,improving regulatory agency capabilities,building monitoring outposts,and strengthening the legal framework.
medical devicesvigilance systemadverse event monitoringriskpilot
万方数据
维普
