【CODEX】一次性使用脑积水分流器注册技术审查 指导原则(1-3)
一次性使用脑积水分流器注册技术审查
指导原则
Guidelines for Technical Review of Single-use Hydrocephalus Shunt Registration
一、前言
I. Introduction
本指导原则旨在指导注册申请人/生产企业对一次性使用脑积水分流器注册申报资料的准备及撰写，同时也为技术审评部门审评注册申报资料提供参考。
This Guideline aims at guiding registration applicant/manufacturer in preparation and writing of application dossiers for registration of the single-use hydrocephalus shunt as well as providing reference for technical review department in reviewing the application dossiers.
本指导原则是对一次性使用脑积水分流器注册申报资料的一般要求，申请人/生产企业应依据具体产品特性确定其中内容是否适用，若不适用，需具体阐述理由及相应的科学依据，并依据产品的具体特性对注册申报资料的内容进行充实和细化。
This Guideline is the general requirements for registration application dossiers of single-use hydrocephalus shunt.The applicant/manufacturer shall determine whether the specific contents herein are applicable according to the characteristics of specific products. If not applicable, the reasons and the corresponding scientific basis shall be explained, and the application dossiers should be enriched and detailed according to the characteristics of specific products.
本指导原则是对申请人/生产企业和审查人员的指导性文件, 不涉及注册审批等行政事项，亦不作为法规强制执行, 如有能满足相关法规要求的其他方法，也可以采用，但是需要应提供详细的研究资料和验证资料。应在遵循相关法规的前提下使用本指导原则。
This Guideline is a guiding document for the applicant/manufacturer and the reviewer, which does not involve the registration approval and other administrative matters, and shall not be enforced as a law. Other alternative approach that meets the regulatory requirements may also be adopted, but detailed research and verification data are required to be provided. This Guideline shall be used on the premise of complying with relevant regulations.
本指导原则是在现行法规和标准体系以及当前认知水平下制定的，随着法规、标准体系的不断完善和科学技术的不断发展，本指导原则相关内容也将适时进行调整。
This Guideline is formulated under the current regulations and standard systems as well as the present cognitive level; along with the constant improvement of regulations and standards as well as the continuous development of science and technology, this Guideline will also be modified timely.
CODEX是为数不多能够为在全球市场寻求发展的医疗企业提供跨国沟通渠道的专业服务商。CODEX团队由包括医学博士在内的高学历资深的全职员工组成，多年来深耕于医疗服务领域。CODEX拥有生命科学专业且庞大的数据库，同时CODEX医学翻译服务通过了ISO9001:2015和ISO17100:2015双重质量体系认证。在本地化、文档翻译和医学文献翻译方面，CODEX能够提供40多种语言的全方位端到端医学内容和咨询服务。
我们专注于生命科学，与客户紧密合作，为客户提供精准的医学解决方案，与客户一起顺利应对全球市场、消费者以及监管和专利环境所面临的挑战。
