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【CODEX】接受医疗器械境外临床试验数据技术指导原则

接受医疗器械境外临床试验数据技术指导原则

Technical Guideline for Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices

 

为了更好满足公众对医疗器械的临床需要,促进医疗器械技术创新,根据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号)及我国医疗器械注册管理相关要求制定本指导原则。本指导原则旨在为申请人通过医疗器械境外临床试验数据申报注册以及监管部门对该类临床试验数据的审评提供技术指导,避免或减少重复性临床试验,加快医疗器械在我国上市进程。

In order to better meet the public's clinical needs for medical devices and promote technological innovation in medical devices, according to the Opinions on Deepening the Reform of Review and Approval System and Encouraging Innovation of Drugs and Medical Devices (Office [2017] No. 42) issued by General Office of the CPC Central Committee and General Office of the State Council as well as the national requirements for medical device registration management, this Guideline is hereby formulated. This Guideline is intended to provide technical guidance for applicants to apply for registration using data derived from overseas clinical trials of medical devices and for supervision authorities to review such clinical trial data, to avoid or reduce repetitive clinical trials and speed up marketing of medical devices in China.


一、范围

I. Scope

 

本指导原则适用于指导医疗器械(含体外诊断试剂)在我国申报注册时,接受申请人采用境外临床试验数据作为临床评价资料的工作。

This Guideline is applicable to guiding the acceptance of data derived from overseas clinical trials of a medical device (including IVD reagent) as the materials for clinical evaluation, when the applicant applies for registering the medical device in China.

 

本指导原则中涉及的境外临床试验数据是指,全部或同期在境外具备临床试验开展所在国家(地区)要求条件的临床试验机构中,对拟在我国申报注册的医疗器械在正常使用条件下的安全有效性进行确认的过程中所产生的研究数据。

The overseas clinical trial data involved in this Guideline refer to the research data generated during the validation of the safety and effectiveness of the medical device intended for registration in China under normal use conditions, by qualified clinical trial institutions in the country (region) where the clinical trial is carried out in the whole or same period.




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