医疗器械委托生产流程剖析

Analysis of the Process of Medical Device Contract Manufacturing

自医疗器械注册人制度实施以来,通过医疗器械注册与生产的解绑及产品规模化委托生产,成功实现了医疗器械产业的快速产业化生产。尽管该举措解决了企业面临的资金、产品转换周期、人才、厂房等问题,但在进行委托生产转产过程中仍存在法规条款理解不透彻、转换流程不清晰等问题。文章旨在对医疗器械委托生产流程进行剖析,运用“二步转产法”简明扼要地对委托生产产品的设计转换、注册和生产许可变更等注意事项进行了梳理和解读。

Since the implementation of the medical device registrant system,the fast industrial production of medical devices has been achieved through the separation of medical device registration and production,as well as the scaled commissioning of production.Although this measure has solved problems faced by enterprises,such as funding,product transfer cycle,talent,and factory space,there are still issues with the understanding of regulations and the unclear transfer process in the commissioning production process.This paper aims to analyze the process of medical device commission production,and to briefly summarize and interpret the precautions for the design transfer,registration,and production license change of commission production products using the“two-step transfer method”.