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【CODEX】脊柱后路内固定系统注册技术审查 指导原则(1-5)

脊柱后路内固定系统注册技术审查

指导原则

Guideline for Technical Review of Posterior Spinal Internal Fixation System Registration

一、前言

I Introduction

 

脊柱手术目的是矫正脊柱畸形、缓解疼痛、稳定脊柱和保护神经,脊柱后路内固定术是主要治疗的手段之一,其手术中使用的脊柱后路内固定系统产品的安全性和有效性直接影响着疾病的治疗效果。本指导原则旨在指导为注册申请人对脊柱后路内固定系统产品的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。

The purpose of spinal surgery is to correct spinal deformity, relieve pain, stabilize the spine and protect nerves. Posterior spinal internal fixation is one of the main treatments. The safety and effectiveness of the posterior spinal internal fixation system used in surgery directly affect the treatment effect. This Guideline aims at guiding registration applicants in preparation and writing of application dossiers for registration of posterior spinal internal fixation system products as well as providing reference for technical review authorities in reviewing application dossiers.

 

本指导原则系对脊柱后路内固定系统的一般要求,申请人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 posterior spinal internal fixation system. The applicant shall determine whether specific contents in the dossiers are applicable according to specific product characteristics. If not, reasons and the corresponding scientific basis shall be explained and the contents of registration application dossiers shall be supplemented and detailed.

 

本指导原则是对申请人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,但应提供详细的研究资料和验证资料。应在遵循相关法规和标准的前提下使用本指导原则。 

This Guideline is a guiding document for the applicant and reviewer which does not cover administrative matters involved in registration approval and is not to be enforced as a regulation. Other alternative approach that meets the regulatory requirements may also be adopted, but detailed research and verification documents shall be provided. This Guideline shall be used on the premise of complying with relevant laws, regulations, and standards.

 

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.



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