How are in vitro diagnostic reagents classified?

How are in vitro diagnostic reagents classified?

In vitro diagnostic reagents are classified into Class I, Class II, and Class III products according to their product risk level, from low to high.

Class I in vitro diagnostic reagent products mainly include: (1) Microbial culture media (not used for microbial identification and drug sensitivity testing); (2) Products for sample processing, such as hemolytic agents, diluents, and staining solutions.

Class II in vitro diagnostic reagent products mainly include: (1) Reagents for protein detection; (2) Reagents for carbohydrate detection; (3) Reagents for hormone detection; (4) Reagents for enzyme detection; (5) Reagents for ester detection; (6) Reagents for vitamin detection; (7) Reagents for inorganic ion detection; (8) Reagents for drug and drug metabolite detection; (9) Reagents for autoantibody detection; (10) Reagents for microbial identification or drug sensitivity testing; (11) Reagents for the detection of other physiological, biochemical, or immunological indicators.

Class III in vitro diagnostic reagent products mainly include: (1) Reagents related to the detection of pathogenic pathogen antigens, antibodies, and nucleic acids; (2) Reagents related to blood type and tissue typing; (3) Reagents related to human gene detection; (4) Reagents related to hereditary diseases; (5) Reagents related to the detection of narcotic drugs, psychotropic drugs, and medical toxic drugs; (6) Reagents related to the detection of therapeutic drug targets; (7) Reagents related to tumor marker detection; (8) Reagents related to allergic reactions (allergens).

How are in vitro diagnostic reagents of different categories managed?

Class I in vitro diagnostic reagents are managed through filing, while Class II and Class III in vitro diagnostic reagents are managed through registration. For Class I in vitro diagnostic reagents within the country, the filer submits filing materials to the municipal food and drug administration department. For Class II in vitro diagnostic reagents within the country, the provincial, autonomous region, or municipality directly under the Central Government food and drug administration department reviews the application and issues a medical device registration certificate upon approval. For Class III in vitro diagnostic reagents within the country, the State Food and Drug Administration reviews the application and issues a medical device registration certificate upon approval.