【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-英文版
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是為數不多能夠為在全球市場尋求發展的醫療企業提供跨國溝通渠道的專業服務商。CODEX團隊由包括醫學博士在內的高學歷資深的全職員工組成，多年來深耕于醫療服務領域。CODEX擁有生命科學專業且龐大的數據庫，同時CODEX醫學翻譯服務通過了ISO9001:2015和ISO17100:2015雙重質量體系認證。在本地化、文檔翻譯和醫學文獻翻譯方面，CODEX能夠提供40多種語言的全方位端到端醫學內容和咨詢服務。
我們專注于生命科學，與客戶緊密合作，為客戶提供精準的醫學解決方案，與客戶一起順利應對全球市場、消費者以及監管和專利環境所面臨的挑戰。
