【CODEX】以醫療器械作用為主的藥械組合產品注冊審查指導原則(2022年第3號)-英文版
【CODEX】以醫療器械作用為主的藥械組合產品注冊審查指導原則
(2022年第3號)-英文版PDF
以醫療器械作用為主的藥械組合產品注冊審查指導原則
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提供生命科學翻譯和本地化服務的公司,作為中國專業的生命科學翻譯公司之一以及國內為數不多的通過國際ISO17100: 2015認證的醫學翻譯提供商,CODEX科譯擁有更多的醫學資深語言專家,能實現40多種語言對的互譯,接受更高難度的醫學領域的項目挑戰,并在最短時間內適應以給出最合理的解決方案。保證最高質量,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。





