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【CODEX】一次性使用脑积水分流器注册技术审查 指导原则(4-6)

三、注册申报资料要求

III Requirements for Registration Application Dossiers

 

(五)临床评价资料

(V) Clinical Evaluation Data

 

临床评价资料应按照《医疗器械注册管理办法》(国家食品药品监督管理总局令第4号)要求提交,并可参考《医疗器械临床评价技术指导原则》(国家食品药品监督管理总局通告2015年第14号)选择适合的评价方法。若产品需要进行临床试验,应按照《医疗器械临床试验质量管理规范》(国家食品药品监督管理总局令第25号)提交临床试验方案、临床试验报告、分中心小结、统计分析总报告及伦理委员会批件。临床试验的设计应紧密围绕产品的适用范围进行,从预期临床效果、应用病种、适用人群等方面充分验证产品的安全性及有效性。对于腔室连接型式不同的分流器,应分别进行临床试验。

The clinical evaluation data shall be submitted in accordance with the requirements of “Provisions for Medical Device Registration” (CFDA Decree No. 4), and may refer to “Technical Guidelines for Clinical Evaluation of Medical Devices” (CFDA Notice No. 14, 2015) for selection of appropriate evaluation method. If the product requires clinical trials, the clinical trial protocol, clinical trial report, sub-center summary, statistical analysis report, and approval documents of the Ethics Committee shall be submitted in accordance with the “Good Clinical Practice for Medical Devices” (CFDA Decree No. 25). The design of clinical trials shall be closely related to the applicable scope of the product, and shall adequately verify the safety and effectiveness of the product in terms of expected clinical outcome, applied diseases, and applicable population etc. Shunts with different chamber connection types shall be tested separately in clinical trials.



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