【CODEX翻譯】接受醫(yī)療器械境外臨床試驗數(shù)據(jù)技術(shù)指導(dǎo)原則-英文版
發(fā)布日期：2021-12-24
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【CODEX翻譯】接受醫(yī)療器械境外臨床試驗數(shù)據(jù)技術(shù)指導(dǎo)原則-英文版
接受醫(yī)療器械境外臨床試驗數(shù)據(jù)技術(shù)指導(dǎo)原則
Technical Guideline for the Acceptance of Data Derived from Overseas Clinical Trials of Medical Devices
為了更好滿足公眾對醫(yī)療器械的臨床需要，促進醫(yī)療器械技術(shù)創(chuàng)新，根據(jù)中共中央辦公廳、國務(wù)院辦公廳《關(guān)于深化審評審批制度改革鼓勵藥品醫(yī)療器械創(chuàng)新的意見》（廳字〔2017〕42號）及我國醫(yī)療器械注冊管理相關(guān)要求制定本指導(dǎo)原則。本指導(dǎo)原則旨在為申請人通過醫(yī)療器械境外臨床試驗數(shù)據(jù)申報注冊以及監(jiān)管部門對該類臨床試驗數(shù)據(jù)的審評提供技術(shù)指導(dǎo)，避免或減少重復(fù)性臨床試驗，加快醫(yī)療器械在我國上市進程。
In order to better meet the public's clinical needs for medical devices and promote the technological innovation of medical devices, according to the Opinions on Deepening the Reform of Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices (Office [2017] No. 42) issued by the 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 relevant authorities to review such clinical trial data, to avoid or reduce repetitive clinical trials and speed up the marketing of medical devices in China.
1 范圍
1 Scope
本指導(dǎo)原則適用于指導(dǎo)醫(yī)療器械（含體外診斷試劑）在我國申報注冊時，接受申請人采用境外臨床試驗數(shù)據(jù)作為臨床評價資料的工作。
This Guideline is formulated to guide the acceptance of data derived from overseas clinical trials of a medical device (including in-vitro diagnostic (IVD) reagents) as the dossiers for clinical evaluation, when an applicant applies for the registration of a medical device in China.
本指導(dǎo)原則中涉及的境外臨床試驗數(shù)據(jù)是指，全部或同期在境外具備臨床試驗開展所在國家（地區(qū)）要求條件的臨床試驗機構(gòu)中，對擬在我國申報注冊的醫(yī)療器械在正常使用條件下的安全有效性進行確認的過程中所產(chǎn)生的研究數(shù)據(jù)。
The overseas clinical trial data involved in this Guideline refers to all research data or the data generated over the same-period during the validation of the safety and effectiveness of a medical device intended for registration in China under normal use conditions, by qualified clinical trial institutes in the country (region) where the clinical trial is carried out.
CODEX北京科譯翻譯有限公司是一家專業(yè)提供生命科學(xué)翻譯和本地化服務(wù)的公司，作為中國專業(yè)的生命科學(xué)翻譯公司之一以及國內(nèi)為數(shù)不多的通過國際ISO17100: 2015認證的醫(yī)學(xué)翻譯提供商，CODEX科譯擁有更多的醫(yī)學(xué)資深語言專家，能實現(xiàn)40多種語言對的互譯，接受更高難度的醫(yī)學(xué)領(lǐng)域的項目挑戰(zhàn)，并在最短時間內(nèi)適應(yīng)以給出最合理的解決方案。保證最高質(zhì)量，100%按時交付，高效、完善的售后保障是CODEX科譯給客戶的用心承諾。
CODEX
is a leading provider of cross-border communications based in Beijing.
With our exclusive database in life science, and ISO 17100:2015
certified, CODEX has the required expertise and experience in
localization, documentation, and medical literature to deliver a full
range of end-to-end content and consulting services in many languages.
We closely work with clients to deliver solutions to the challenges of
engaging markets, consumers, and regulatory and patent environments
worldwide.
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