【CODEX】以医疗器械作用为主的药械组合产品注册审查指导原则-英文版
以医疗器械作用为主的药械组合产品注册审查指导原则
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是为数不多能够为在全球市场寻求发展的医疗企业提供跨国沟通渠道的专业服务商。CODEX团队由包括医学博士在内的高学历资深的全职员工组成，多年来深耕于医疗服务领域。CODEX拥有生命科学专业且庞大的数据库，同时CODEX医学翻译服务通过了ISO9001:2015和ISO17100:2015双重质量体系认证。在本地化、文档翻译和医学文献翻译方面，CODEX能够提供40多种语言的全方位端到端医学内容和咨询服务。
我们专注于生命科学，与客户紧密合作，为客户提供精准的医学解决方案，与客户一起顺利应对全球市场、消费者以及监管和专利环境所面临的挑战。
