医疗器械软件注册技术审查指导原则

2022-6-15 19:34| 发布者: 医智宝| 查看: 2354| 评论: 0|来自: 国家药监局

摘要: 本指导原则适用于医疗器械软件的注册申报,包括第二类、第三类医疗器械产品,适用的软件开发方式包括自主开发、部分采用现成软件和全部采用现成软件。医疗器械软件包括独立软件和软件组件。独立软件:作为医疗器械或 ...


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