China Releases New Guidelines for Registration of Products that Combine Drugs and Medical Devices

Seeking to stem confusion among drug and medical device manufacturers, China’s regulatory authorities in July released a draft set of rules clarifying how to register products combining both medical devices and pharmaceuticals in the country. The draft Guidelines for the Registration Review of Device-based Combination Products, set by The National Medical Products Administration (NMPA), clarify that some products defined as combination products in the United States and elsewhere may not meet the same definition in China.

The draft rules call for filing combination drug-device products according to drug-related regulations if their major therapeutic effect is linked to their drug component, and as a medical device if their major therapeutic effect is linked to the device component.

Products classified as device-based include antibacterial orthodontic appliances, soft contact lenses, bone repair materials that contain bone morphogenetic protein-2, and medical masks containing quaternary ammonium salts.

Drug-based combination products include emergency hemostatic materials, lidocaine mussel mucin spray and pilocarpine hydrochloride micro-ophthalmic solution.