Registration of Drug-device Combination Products

NMPA Notice on the Registration Requirements for Drug–Device Combination Products

To strengthen the regulatory oversight and registration management of drug–device combination products, and in accordance with applicable drug and medical device registration regulations, the following requirements were issued on July 23:

I. Definition – Drug–device combination products are medical products composed of both a drug component and a medical device component, produced and supplied as a single integrated product.

II. Registration Pathway – 

• Drug‑led combination products must be registered in accordance with drug registration requirements. 
• Device‑led combination products must be registered following medical device requirements. 

If the drug or device component has already been approved for marketing in China or in the country/region of origin, the corresponding marketing authorization document must be included in the registration submission. Requirements for application dossiers are detailed in relevant regulatory documents and guidance.

III. Attribute Determination – Applicants must fully assess the characteristics of the combination product they intend to register. If the primary mode of action—or attribute—of the product cannot be clearly determined, applicants must submit an attribute determination request to the Center for Medical Device Standards Management (CMDSM) of NMPA before filing the registration application.

IV. Review of Attribute Determination – CMDSM will review the submitted dossiers for accepted attribute determination requests and provide a formal determination based on established procedures. 

Applicants will be informed of the outcome through the Information System for Attribute Definition of Drug–Device Combination Products, and results will be published on the official website.

V. Registration Submission – Applicants must submit the drug or device registration application to NMPA according to the determined attribute of the product. 

The application form must explicitly indicate that the product is a “drug–device combination product.”

VI. Evaluation Mechanism – The Center for Drug Evaluation (CDE) and the Center for Medical Device Evaluation (CMDE) have established a coordination mechanism: 

• For drug‑led products: CDE leads the evaluation. If joint review is needed, the dossier will be forwarded to CMDE for parallel evaluation. 
• For device‑led products: CMDE leads the review. If joint evaluation is required, the dossier will be forwarded to CDE. 

For products undergoing joint evaluation, CDE and CMDE will collaborate on communication and technical discussions. Each center will issue its own evaluation report addressing the safety, effectiveness, and quality controllability of its respective component. The lead center will integrate these assessments, prepare the overall evaluation conclusion, and submit it to the appropriate NMPA department for administrative approval.

VII. Existing Provisions – If relevant regulations or documents already specify the management attributes of certain combination products, those provisions take precedence.

VIII. Implementation – This Notice takes effect on the date of issuance. 

The following documents are simultaneously repealed: 

“Notice on Matters Concerning the Adjustment of Attribute Definition of Drug–Device Combination Products” (NMPA Notice [2019] No. 28) 

“Notice on Matters Concerning the Registration of Drug–Device Combination Products” (Former CFDA Notice [2009] No. 16)