Technical Guideline Of Clinical Evaluation Report For Medical Device Registration (Final)



Technical Guideline of Clinical Evaluation Report for Medical Device Registration

一、前言 Foreword 医疗器械临床评价是采用科学合理的方法对临床数据进行 评价、分析,以确认医疗器械在其适用范围下的安全性、临床性 能和/或有效性的持续进行的活动。
Clinical evaluation of medical devices is an ongoing activity that uses scientific and reasonable methods to evaluate and analyze clinical data in order to confirm the safety, clinical performance and/or effectiveness of medical devices in their applicable scope.
临床评价需持续开展,贯穿医疗器械全生命周期。产品注册 时,注册申请人使用临床评价产生的临床证据,以及其他设计验 证和确认文件、器械描述、说明书和标签、风险分析以及生产信 息,论证产品对安全和有效基本原则的符合性。产品上市后,随 着产品安全性、临床性能和/或有效性信息的不断更新,需周期 性地进行临床评价。
Clinical evaluation should be carried out continuously throughout the whole life cycle of medical devices. When registering a product, the applicant uses clinical evidence resulting from clinical evaluation, as well as other design verification and validation documents, device descriptions, specifications and labels,risk analysis, and manufacturing information, to demonstrate the conformity of the product to basic principles of safety and effectiveness. Periodic clinical evaluation of product safety, clinical performance and/or efficacy is required after the product is marketed, as information on product safety, clinical performance and/or efficacy is updated.
本指导原则在《医疗器械临床评价技术指导原则》的框架下, 针对上市前临床评价,阐明用于医疗器械注册申报的临床评价报 告需包含的主要内容并细化相应要求,为注册人编写上市前临床 评价报告以及药品监督管理部门审评上市前临床评价报告提供 技术指导。
Under the framework of Technical Guidelines for Medical Device Clinical Evaluation, for premarket clinical evaluation, this Guideline clarifies the main content of the clinical evaluation report for medical device registration application and specifies the corresponding requirements. This provides technical guidance for the preparation of pre-market clinical evaluation reports by registrants and the evaluation of pre-market clinical evaluation reports by drug regulatory departments