Answer: This is a combined drug-device product, subject to the most complex regulatory procedures. The NMPA Center for Standardization will first conduct attribute classification: 

Device-dominant products (e.g., drug-eluting stents): Register as medical devices, with additional pharmaceutical research data required, leading to a longer review cycle. 

Drug-dominant products (e.g., pre-filled syringes): Register as pharmaceuticals, and the syringe component shall complete DMF filing. We have a dedicated team specializing in combined drug-device products to guarantee accurate and correct registration pathways.