【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

（2022年第3号）-英文版PDF

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.