Chinese Regulators Revise Drug-Device Combination Product Registration Requirements

China’s National Medical Products Administration (NMPA) has updated registration requirements and processes pertaining to combination products that include drug and medical device (drug-device) components.

Determining primary modes of action for NMPA registration pathways

A new NMPA announcement (link in Chinese) explains that Chinese market applicants must determine the primary mode of action of their combination products; this determination will designate whether a product is considered a drug or a medical device, and thus identify the product’s appropriate NMPA regulatory pathway.

In cases where applicants cannot determine appropriate designations of their combination products on their own, they have the option to apply for designation determinations with the National Institutes for Food and Drug Control, or NIFDC.

Ancillary Chinese marketing approval considerations

For combination products with ancillary or secondary components—whether drug or device—that have obtained separate marketing approvals in China or in their original countries of manufacture, certification for those approvals must be included in registration applications to the NMPA.