【CODEX】医疗器械生产监督管理办法(3-4)-EN
第三章 委托生产管理
Chapter III Administration of Entrusted manufacturing
第二十六条 医疗器械委托生产的委托方应当是委托生产医疗器械的境内注册人或者备案人。其中,委托生产不属于按照创新医疗器械特别审批程序审批的境内医疗器械的,委托方应当取得委托生产医疗器械的生产许可或者办理第一类医疗器械生产备案。
Article 26.The entrusting party that entrusts medical device manufacturing shall be the registration applicant or filing entity of the entrusted medical device manufacturing within the territory of China. Among which, if the medical device under entrusted manufacturing does not belong to the domestic medical device to be reviewed and approved in accordance with special review and approval procedures for innovative medical devices, then the entrusting party shall obtain a manufacturing license of medical device manufacturing to be entrusted or conduct a filing of Class I medical device manufacturing.
医疗器械委托生产的受托方应当是取得受托生产医疗器械相应生产范围的生产许可或者办理第一类医疗器械生产备案的境内生产企业。受托方对受托生产医疗器械的质量负相应责任。
The entrusted party of medical device manufacturing shall be the domestic manufacturer who has obtained the manufacturing license with corresponding range covering the entrusted medical device manufacturing or who has conducted the filing for Class I medical device manufacturing. The entrusted party is responsible for the quality of entrusted medical device manufacturing.