我国医疗器械注册人制度下委托生产现状分析及建议

Analysis and Suggestions on Status Quo of Commissioned Production under Medical Device Marketing Authorization Holder System in China

目的 梳理并分析医疗器械注册人制度试点工作的现状和存在的问题,为全面落地实施医疗器械注册人制度提供参考意见。方法 运用文献分析法、对比分析法、实地调研法综合分析医疗器械注册人制度下进行委托生产现状、优势以及风险。结果 医疗器械注册人制度下进行委托生产带来红利的同时也会带来风险。结论 应从注册人、受托生产企业、监管部门不同主体考虑完善医疗器械注册人制度,加强产品委托生产的质量监管。

Objective Sort out and analyze the current status and existing problems of the pilot work of the medical device marketing authorization holder system to provide reference opinions for the full implementation of the medical device marketing authorization holder system.Methods Use literature analysis,comparative analysis and field research to comprehensively analyze the status,advantages and risks of commissioned production under the medical device marketing authorization holder system.Results The commissioned production under the medical device marketing authorization holder system brings dividends and also brings risks.Conclusion We should consider improving the medical device marketing authorization holder system from marketing authorization holder,the entrusted manufacturer,and the regulatory authority,and strengthen the quality supervision of the entrusted production of products.