我国与美国欧盟医疗器械上市注册流程比较

Comparison of Registration Process of Medical Devices Before Marketing Between China,the USA and the EU

目的 分析我国与美国、欧盟医疗器械上市前注册流程的差异,为加强我国的医疗器械监管工作提供参考。方法 从法规沿革、管理模式方面比较我国与美国、欧盟医疗器械上市的差异,再以全自动生化分析仪为例,比较注册申报流程的差异。结果 在监管类别、申报途径、审评时限等方面,各国注册流程侧重点各有不同,但都能保证上市产品的安全性和有效性。结论 实施全面、系统、科学的医疗器械管理制度,落实医疗器械审评审批制度的改革要求,确保了我国医疗器械产品的安全性和有效性。

Objective To analyze the differences of registration process of medical devices before marketing between China, the United States of America(USA) and the European Union(EU),and to provide a reference for strengthening the supervision ofmedical devices in China.Methods The differences between China,the USA and the EU in the marketing of medical deviceswere compared from the evolution of regulations and management mode,and then the automatic biochemical analyzer was taken asan example to compare the differences between China,the USA and the EU in the registration and declaration process.Results Interms of the regulatory categories,the declaration channels,the time limit of review and so on,the registration process of eachcountry had different emphasis, but all could ensure the safety and effectiveness of marketed products.Conclusion Acomprehensive,systematic and scientific medical device management system can implement the reform requirements of the medicaldevice review and approval system,and ensure the safety and effectiveness of medical devices in China.