Guidelines For Device-based Combination Products By CMDE

On July 26, 2021, CMDE issued the Guidelines for the Registration Review of Device-based Combination Products (Draft) to guide applicants’ registration application.

Given the different definitions for combination products in other countries, some combination products in the United States may not be defined as combination products in China.

In China, combination products are defined as a single entity that consists of both drug and medical device. If the medical device plays the main role, it will be classified as device-based combination product. Otherwise, it will be classified as drug-based combination product.

According to the Summary of Classification Results of the First Batch of Drug-device Combination Products in 2021 issued by Center for Medical Device Standardization Administration of NMPA on July 7, 2021, the following products are classified as device-based combination products:

• Soft contact lenses
• Bone repair materials containing bone morphogenetic protein-2 (rhBMP-2)
• Antibacterial orthodontic appliances
• Minimally cross-linked sodium hyaluronate gel for injection
• Medical masks containing quaternary ammonium salts

For device-based combination product, the registration application should be submitted to CMDE, a department of NMPA that is responsible for the registration of medical devices.

As per the Summary, the following products are classified as drug-based combination products:

• Lidocaine mussel mucin spray
• Gentamicin sulfate collagen sponge
• Pilocarpine hydrochloride microophthalmic solution
• Staccato Alprazolam
• Emergency hemostatic materials

These products should be submitted to Center for Drug Evaluation of NMPA for registration application.

Notes:

• For the registration of device-based combination products in China, it is advised to conduct a classification identification prior to the launch of the registration project. With an classification result from Center for Medical Device Standardization Administration, NMPA, the manufacturers can obtain some opinions from the NMPA and make the most reasonable strategy for the product registration.
• For the registration of drug-based combination products, the drug needs to be NMPA approved.

Contact us for：

• Classification of combination product
• Requirements for application dossiers of device-based combination product
• Requirements for clinical evaluation of device-based combination product