【CODEX】以醫(yī)療器械作用為主的藥械組合產(chǎn)品注冊(cè)審查指導(dǎo)原則（2022年第3號(hào)）-英文版
Date：2023-01-28
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【CODEX】以醫(yī)療器械作用為主的藥械組合產(chǎn)品注冊(cè)審查指導(dǎo)原則
（2022年第3號(hào)）-英文版PDF
以醫(yī)療器械作用為主的藥械組合產(chǎn)品注冊(cè)審查指導(dǎo)原則
Guideline for Registration Review of Drug-device Combination Products with Medical Devices
as the Primary Mode of Action
The drug-device combination products with medical devices as the primary mode of action (referred to as drug-device combined medical devices in this guideline) is expected to be safer and more effective in the process of disease prevention and treatment, but it may also raise new technical concerns. Therefore, in order to further guide the applicant's preparation for the registration of drug-device combination products, encourage the development of such innovative products, this Guideline is formulated.
This Guideline is a general guidance document for the registration review of the drug-device combined medical devices. Due to the variety of such products, this Guideline mainly provides guidance on drug-related requirements in the drug-device combined medical devices, the applicant can base on the characteristics of specific products to enrich and refine the information. Although this Guideline provides preliminary guidance and recommendations for the registration of such products, it will not limit the technical review and administrative approval of the medical device-related management departments and the applicant’s preparation of the application dossiers for the registration of such products.
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(guó)專業(yè)的生命科學(xué)翻譯公司之一以及國(guó)內(nèi)為數(shù)不多的通過(guò)國(guó)際ISO17100: 2015認(rèn)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(yǔ)言專家，能實(shí)現(xiàn)40多種語(yǔ)言對(duì)的互譯，接受更高難度的醫(yī)學(xué)領(lǐng)域的項(xiàng)目挑戰(zhàn)，并在最短時(shí)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(shí)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.
