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The NMPA Issues Circular of Two Registration Review Guiding Principles for Drug-device Combination Products Dominated by Medical Devices

2022-01-18

On January 17th,in order to strengthen the supervision and guidance of the registration of drug-device combination products, and encourage the listing of drug-device combination products of clinical value, the NMPA has formulated two guidelines for registration review, namely, the Medical-device Combination Products with the Main Role of Medical Devices , and Research on the Qualitative and Quantitative and In vitro Release of Drugs in Drug-device Based on the Function of Medical Devices.

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