Borderline and Combination Products
How NMPA handles products at the boundary between medical devices, drugs, cosmetics, and food.
How NMPA handles products at the boundary between medical devices, drugs, cosmetics, and food.
Classification rules for in vitro diagnostic reagents under China's IVD regulatory framework.
How NMPA classifies medical devices using the National Medical Device Classification Catalogue (NMDCC).
China's risk-based medical device classification system — Class I, II, and III — and the three-tier authority split.
How to read and use the NMPA National Medical Device Classification Catalogue.