Registration of Drug-device Combination Products

NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products

With the view to strengthening registration management of drug-device combination products, in accordance with relevant provisions for registration management of drugs and medical devices, matters concerning the registration of drug-device combination products are hereby announced on July 23 as follows:

I. Drug-device combination products refer to medical products composed of drugs and medical devices and produced as a single entity.

II. Drug-led drug-device combination products shall be registered in accordance with the relevant requirements for drugs, and device led drug-device combination products shall be registered in accordance with the relevant requirements for medical devices. Where the drug or medical device contained in a drug-device combination product has been approved for marketing in China or country (region) of origin, the corresponding marketing approval document shall be submitted at the time of registration application. For the requirements for application dossiers of drug-device combination products, please refer to the relevant documents and guidance.

III. The Applicant shall fully evaluate the attributes of the drug-device combination products to be applied for. For the drug device combination products whose attribute cannot be determined, the applicants shall apply for attribute definition to Center for Medical Device Standards Management, NMPA (hereinafter referred to as the “CMDSM”) prior to registration application.

IV. The CMDSM shall review the dossiers for accepted attribute definition application of drug-device combination products, propose opinions on attribute definition as per the procedure, inform the applicants in the Information System for Attribute Definition of Drug-Device Combination Products, and in a timely manner issue the attribute definition results of drug-device combination products to the public on website.

V. Applicants shall submit drug or medical device registration application to NMPA based on determination results on product attribute, and indicate “drug-device combination products” in the application form.

VI. Center for Drug Evaluation, NMPA, has established coordination mechanism together with Center for Medical Device Evaluation. For the drug-device combination products applied as drugs, Center for Drug Evaluation shall lead the evaluation. Where a joint evaluation is required, registration application dossier shall be transferred to Center for Medical Device Evaluation for synchronized evaluation; for the drug-device combination products applied as medical devices, Center for Medical Device Evaluation shall lead the evaluation, where a joint evaluation is required, registration application dossier shall be transferred to Center for Drug Evaluation for synchronized evaluation. For a drug device combination product under joint evaluation, the CDE and the CMDE shall cooperate to carry out the communication and consultation of the product under application; both parties shall issue an evaluation report for the safety, effectiveness and quality controllability of the corresponding part and clarify the evaluation conclusion respectively, and the leading unit shall summarize it, make an overall evaluation and issue the overall evaluation conclusion, and then transfer to corresponding department of NMPA for administrative approval.

VII. Where the management attributes have been clearly specified in relevant regulations and documents, such provisions shall prevail.

VIII. The Notice shall be implemented as of the date of issuance. The Notice on Matters Concerning the Registration of Drug-device Combination Products (Former CFDA Notice [2009] No. 16) and the Notice on Matters Concerning the Adjustment of Attribute Definition of Drug-device Combination Products (NMPA Notice [2019] No. 28) shall be simultaneously abolished.