According to "Administrative Measures for the Registration of In Vitro Diagnostic Reagents(CFDA Order No. 5 2014)" IVD reagents are classified into Class Ⅰ, Ⅱ and Ⅲ according to product risk classification from low to high.

(Ⅰ) Class Ⅰ

1. Microbial media (not applicable to microorganism identification and drug sensitivity test);

2. Products for sample processing, e.g. hemolytic agent, diluents, staining solution, etc.  

(Ⅱ) Class Ⅱ

Except defined specially as Class Ⅰ and Ⅲ,  the products belong to Class Ⅱ, mainly including:

1. Reagent used for protein detection;

2. Reagent used for hydrocarbon detection;

3. Reagent used for hormone detection;

4. Reagent used for enzyme detection;

5. Reagent used for ester detection;

6. Reagent used for vitamin detection;

7. Reagent used for inorganic ion detection;

8. Reagent used for detection of drugs and drug metabolites;

9. Reagent used for autoantibody detection;

10. Reagent used for microorganism identification and drug sensitivity test;

11. Reagent used for detection of other physiological, biochemical or immune function index;

(Ⅲ) Class Ⅲ

1. Reagent related to pathogenic pathogen antigen, antibody, nucleic acid and otherwise detection;

2. Reagent related to blood type, tissue matching;

3. Reagent related to human gene detection;

4. Reagent related to hereditary diseases;

5. Reagent related to detection of narcotics, psychotropic drugs, toxic drugs for medical use;

6. Reagent related to detection of therapeutic drug target;

7. Reagent related to detection of tumor marker;

8. Reagent related to allergy (allergen).

If Class Ⅱ l is used for tumor diagnosis, assisted diagnosis, therapeutic process monitoring, or used for hereditary disease diagnosis, assisted diagnosis, etc., it shall be registered and administered as Class Ⅲ. Where the reagent used for detection of drugs and drug metabolites belongs to narcotics, psychotropic drugs or toxic drugs for medical use, it shall be registered and administered as Class Ⅲ.

The calibrator, controls may apply for registration in combination with the matching IVD reagents or separately.

The calibrator, controls used with Class Ⅰ IVD reagent may be registered as Class Ⅱ; when the calibrator, controls used with Class Ⅱ, Ⅲ IVD reagent applies for registration separately, it shall be registered according to the same Class as the reagent; several calibrators, controls shall be registered by higher Class.