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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:
1.
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
.
2.
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
3.
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
4.
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
.
5.
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
.
6.
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.
7.
8.
Hereby inform
Attachment: 1.
2.
State Food and Drug Administration
July 23, 2021
Attachment 1.
Attachment 1.
Announcement No.
52 of the State Drug Administration of 2021 Annex 2.
doc
