On July 26, 2021, CMDE issued the Guidelines for the Registration Review of Device-based Combination Products (Draft) to guide applicants' registration applications.
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 devices. If the medical device plays the main role, it will be classified as a device-based combination product. Otherwise, it will be classified as a drug-based combination product.
According to the Summary of Classification Results of the First Batch of Drug-device Combination Products in 2021 issued by the 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 products, 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 the Center for Drug Evaluation of NMPA for the registration application.
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Tracy Yu
Senior Project Manager
Seattle WA
United States
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