In vitro diagnostic reagent registration/filing agency
The first kind of in vitro diagnostic reagents shall be subject to product record management.  Class II and Class Ill in vitro diagnostic reagents shall be subject to product registration management.
Import the first kind of in vitro diagnostic reagents for filing, and the filer shall submit the filing materials to National Medical Products Administration.  Imported Class II and Class 111 in vitro diagnostic reagents shall be examined by National Medical Products Administration, and after approval, a medical device registration certificate shall be issued.

Centralized management department
National Medical Products Administration is in charge of the registration and filing management of in vitro diagnostic reagents nationwide, organizes the review and approval of imported second and third types of in vitro diagnostic reagents, and records and  related  supervision  and  management of imported first type of in vitro diagnostic reagents according to law;
National Medical Products Administration Medical Device Technical Evaluation Center is responsible for the technical evaluation of the application for registration, change of registration, renewal of registration, etc. of Class Ill in China and imported Class II and Class Ill in vitro diagnostic reagents.

The management category of “Administrative Measures”
In the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation, reagents, kits, calibrators, quality control products and other products used for in vitro detection of human samples can be used alone or in combination with instruments, appliances, equipment or systems. In vitro diagnostic reagents for blood source screening and in vitro diagnostic reagents labeled with radionuclides are not within the scope of administration measures.