NMPA Combination Products: Latest Classification Results

NMPA Standards Management Center published the “First Batch of Combination Products Classification Results in 2021” on July 7. Worth noted that overseas manufacturers pay more attention to the combination products, such as J&J’S Soft contact lens and Abbvie’s Risankizumab pre-filled portable dispenser, as shown below:

Combination product with primary action of drug:

• Lidocaine mussel mucin spray
• Gentamicin Sulfate Collagen Sponge
• Pilocarpine hydrochloride trace ophthalmic solution
• Staccato Alprazolam
• First aid hemostatic materials

Combination product with primary action of device:

• Soft contact lens
• Bone repair material containing bone morphogenetic protein-2 (rhBMP-2)
• Bacteriostatic orthodontic appliance
• Micro-crosslinked sodium hyaluronate gel for injection
• Medical masks containing quaternary ammonium salt

Not combination product. Registered as drug:

• Risankizumab pre-filled portable dispenser
• Minocycline Hydrochloride Foaming Agent
• Fluocinolone intravitreal implant
• Finasteride skin spray
• Recombinant Human Follicle Stimulating Hormone Injection
• Semaglutide Injection
• Dexamethasone intravitreal implant (Ozurdex)
• Liraglutide Injection
• Leuprolide mesylate suspension injection (prefilled syringe)

Not combination product. Registered as device:

• Colonoscope lubricating defoamer
• Gastroscope lubricating defoamer

For the classification process and registration requirements for combination products, please click HERE.

Source: https://chinameddevice.com/combination-products-classification-results/