In Vitro Diagnostic Reagents Classification Rules

In-vitro diagnosis reagents (IVDs) refer to the products such as reagents, calibrators, quality controls, and so on, intended for use in diagnosis of disease or other conditions. In China, except two kinds of IVD intended for use in blood source screening and radiolabeled defined as drugs, all of IVD are managed as medical devices, and classified into Class I, Class II and Class III from lower to higher risk degree.
Pursuant to 6840 Subdirectories In Vitro Diagnostic Reagents Classification and Administrative Measures for the Registration of In Vitro Diagnostic Reagents, the basic classification rule as following:

Class I products: lowest risk

Microorganism culture medium (excluding for microorganism identification and medicine allergic assay)
Products for specimen treatment, such as hemolytic agents, diluents, staining solutions, etc.

Class II product: medium risk
Apart from Class III and Class I products, other fall into Class II products, which main include the following reagents:

IVDs to test proteins
IVDs to test glucides;
IVDs to test hormones;
IVDs to test enzymes;
IVDs to test esters;
IVDs to test vitamin;
IVDs to test inorganic ions;
IVDs to test drugs and drug metabolism;
Self-immunity diagnostic reagents;
Microorganism identification or medicine allergic assay diagnostic reagents;
IVDs to test other physiological and biochemical indexes, as well as immunologic function.

Class III products: highest risk

IVDs to test pathogenic antigens, antibodies and nucleic acids;
IVDs to test blood type and tissue typing;
IVDs to test human gene;
IVDs to test genetic disease;
IVDs to test narcotic, psychotropic substances, psychotropic drugs and medical toxic drugs;
IVDs to test drug target;
IVDs to test tumor marker;
IVDs to test allergen;
Flow cytometry related reagents.

For the above classification rules, we shall pay attention on those key points below:

If your product is used for testing protein to diagnosis or auxiliary diagnosis for tumor or genetic disease, your product shall be managed as Class III;
If your product is used for testing drugs which belong to narcotic, psychotropic substances, or medical toxic drugs, and drug metabolism, your product shall be managed as Class III;

The classification rules shall not apply to calibrators and control materials.

The classification of calibrators and control materials of IVDs of Class II and Class III are same to the matching reagents. The classification of calibrators and control materials of IVDs of Class I are managed as class II.

If you want the related laws and regulations about IVD approval in China (English version), you can contact us feel free.

Administrative Measures for the Registration of In Vitro Diagnostic Reagents (CFDA, No.5)
The Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial

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