Guidelines for Technical Review of Single-use Hydrocephalus Shunt Registration
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.
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.
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.