NMPA Announcement on Two Guidelines for Registration Review of Drug-Device Combination Products with Device Taking Primary Mode of Action

In order to enhance the regulation and guidance for the registration of drugdevice combination products, further encourage the marketing of drug-device combination products with clinical value, and build a management mode for drugdevice combination products suitable for China's national conditions, National Medical Products Administration has set the technical evaluation of drug-device combination products as a research projectin regulatory science, and organized to formulate theGuideline for Registration Review Drug-Device Combination Products with Device Taking Primary Mode of Action and the Guideline for Registration Review of Qualitative, Quantitative and In Vitro Release Studies of Drugs in Drug-Device Combination Products with Device Taking Primary Mode of Action, which were issued on January 11, 2022.