Home    CFDA Registration   AQSIQ Register   CIQ Inspection   CNCA Registration   NHFPC(MOH) Register   MOA Register      Contact Us

Classification of In Vitro Diagnostic Reagents(IVD) in China

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.
        Similar topics:


Similar Topics
 Top Articles
 Latest Articles
  Search Tools
China National GB Standards Search
China HS Code Search
Customs Tariff & Tax Search
CIQ Import Inspection Requirements Search
China Cosmetics Formula Ingredients Analysis Systemกก
China Foods Formula Ingredients Analysis System
Contact Us
Post Message
  |  Home  |  About Us  |  Our Service   |   China Regulations News  |  Contact Us  |

+86-400-6578191        info@sfdachina.com 
106# Zhongmao Mansion,No.1 Beizhan Road, Shenzhen,China 518000
©  RJS Copyright  2001-2020 All Rights Reserved