According to SFDA Notice [2007]229 "Management Method of In Vitro
Diagnostic Reagents Registration (Interim)" taken effect as of June 1, 2007, IVD
reagents regulated as Medical Devices are classified into Class I, II, or III
according to the product risk level from low to high in turn.
Class III: Highest risk
Reagents used in relation to:
1. Test of pathogenic antigen, antibody and nucleic acid;
2. Blood type and tissue typing;
3. Test of human genes;
4. Hereditary diseases;
5. Test of anesthetic, psychiatric drug and toxic medicine for medical purpose;
6. Test of drug target;
7. Test of tumor marker;
8. Allergic reaction (allergen)
Class II: Medium risk
Apart from Class III and Class I products, others fall into Class II products,
which mainly include the following reagents detected:
1. Proteins;
2. Glucide;
3. Hormones;
4. Enzymes;
5. Esters;
6. Vitamins;
7. Inorganic ions;
8. Drugs and their metabolic by-products;
9. Autologous Antibody;
10. Microbes Identification (except pathogens) and Drug allergic assays;
11. Other physiological, biochemical and immune function indicators
Class I: Lowest risk
Reagents used in relation to:
1. Microbe Culture medium (excluding for microbe identification and drug
allergic assay);
2. Sample treatment, such as hemolytic reagents, dilution solutions and stain
solutions.
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