日本医疗器械上市许可持有人启示

医疗器械上市许可持有人是日本医疗器械上市许可的前置主体资格,建立了由总经理、上市后安全负责人和质量保证负责人构成的质量保障“铁三角”,允许生产和上市相分离,分为营销授权持有人和指定营销授权持有人两种类型。学习日本医疗器械上市许可持有人先进经验,结合我国国情,定义好、架构好医疗器械注册人制度,才能真正提高我国医疗器械产品研发水平,促进医疗器械产业高质量稳步发展。

Medical Device Marketing Authorization Holder is a pre-required qualification to register and market medical devices in Japan.It allows the separation of marketing and manufacture.General manager,post marketing safety manager and quality assurance manager form the“iron triangle”as Medical Device Marketing Authorization Holder,which can be identified as Marketing Authorization Holder or Designated Marketing Authorization Holder.This study aims to combine knowledge learnt from the Medical Device Marketing Authorization Holder system in Japan with current situation of medical device industry in China so as to define and organize the medical device registration holder system,improve the research and development of medical device,as well as accelerate the steady growth of medical device industry in China.