In order to strengthen the registration management of drug-device combination products, in accordance with the relevant regulations on the registration and management of drugs and medical devices, the following is hereby notified on matters related to the registration of drug-device combination products:
A combination of medicine and equipment refers to a medical product that is composed of medicines and medical equipment and is produced as a single entity
Drug-device combination products that focus on the role of drugs should be registered in accordance with the relevant requirements for drugs; drug-device combination products that focus on the role of medical devices should be filed and registered in accordance with the relevant requirements for medical devices
For the medicines or medical devices contained in the drug-device combination product that have been approved for marketing in China or the country (region) of manufacture, the corresponding marketing certification documents shall be submitted at the time of application for registration
Please refer to the relevant documents and guiding principles for the application materials requirements of drug-device combination products
The applicant should fully evaluate the attributes of the drug-device combination product it intends to declare
For drug-device combination products where the management attributes cannot be determined, the applicant should apply to the Medical Device Standards Management Center of the State Drug Administration (hereinafter referred to as the Standard Management Center) for the definition of the drug-device combination products before applying for registration
The Standards Management Center reviews the accepted application materials for the attribute definition of the drug-device combination product, proposes attribute definition opinions according to the procedures, informs the applicant in the drug-device combination product attribute definition information system, and promptly publicizes the drug-device combination product attribute definition on its website Result
The applicant shall apply to the State Drug Administration for registration of drugs or medical devices according to the result of product attribute definition, and indicate "medicine and device combination products" in the application form
Establish a coordination mechanism between the Drug Evaluation Center of the State Drug Administration and the Medical Device Technology Evaluation Center
Drug-device combination products registered in accordance with the drug application shall be reviewed by the Drug Evaluation Center.
If joint review is required, the registration application materials shall be transferred to the Medical Device Technology Review Center for simultaneous review; drug-device combination products declared in accordance with the medical device registration shall be reviewed.
The review is led by the Medical Device Technology Review Center.
If a joint review is required, the registration application materials shall be forwarded to the Drug Review Center for simultaneous review
For joint-reviewed drug-device combination products, the drug review center and the medical device technical review center shall coordinate the communication and consultation of the declared products; both parties shall issue reviews on the safety, effectiveness, and quality controllability of the corresponding parts.
Report and clarify the review conclusions.
The lead unit will summarize and make an overall evaluation.
After the overall review conclusion is issued, it will be transferred to the corresponding business department of the State Drug Administration for administrative approval
If there are clear management attributes in relevant regulations and documents, they shall be implemented in accordance with the regulations
This notice will be implemented from the date of issuance, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Notice No.
16 of 2009) and the "Notice on Regulating Matters Concerning the Definition of the Attributes of Medicine and Device Combination Products" 》(Announcement No.
28 of 2019 of the State Drug Administration) shall be repealed at the same time
Procedure for defining the attributes of a combination product of medicine and equipment
Requirements and descriptions of application materials for attribute definition of drug-device combination products
State Food and Drug Administration
July 23, 2021Attachment 1.
docx of the State Drug Administration's 2021 Circular No.
52 of the State Drug Administration of 2021 Annex 2.