Major adjustment! Issued by the state: the latest classification standard of in vitro diagnostic reagents was officially announced!

Classification rules for in vitro diagnostic reagents
Article 1 in order to standardize the classification management of in vitro diagnostic reagents, these rules are formulated in accordance with the regulations on the supervision and administration of medical devices.
Article 2 the in vitro diagnostic reagents mentioned in these rules refer to the in vitro diagnostic reagents managed according to medical devices. In vitro diagnostic reagents used for blood source screening and in vitro diagnostic reagents marked with radionuclides in accordance with drug administration do not fall within the scope of these rules.
Cell culture medium products used for cell therapy, cell reinfusion, assisted reproduction, etc. do not fall within the scope of these rules.
Article 3 these rules are used to guide the formulation and adjustment of the classification catalogue of in vitro diagnostic reagents and determine the management category of new in vitro diagnostic reagents.
Article 4 the management category of in vitro diagnostic reagents shall be determined according to the degree of product risk. Factors affecting the risk level of in vitro diagnostic reagents include but are not limited to the following:
（1） The intended use and indication of the product, as well as the intended use environment and the professional knowledge of the user;
（2） The influence degree of test result information on medical diagnosis and treatment;
（3） Impact of test results on personal and / or public health.
Article 5 the in vitro diagnostic reagents are classified into the first, second and third categories according to the risk level from low to high.
The first type of in vitro diagnostic reagents refer to in vitro diagnostic reagents with low personal risk and no public health risk, which can be ensured to be safe and effective by routine management. They are usually auxiliary reagents for testing.
The second category of in vitro diagnostic reagents refers to in vitro diagnostic reagents with moderate personal risk and / or public health risk, the test results are usually one of several determinants, the wrong results will not endanger life or cause major disability, and strict control and management are required to ensure their safety and effectiveness.
Class III in vitro diagnostic reagents refer to in vitro diagnostic reagents that have high personal and / or public health risks, provide key information for clinical diagnosis, and the wrong results will pose a serious threat to personal and / or public health and safety. Special measures need to be taken to strictly control and manage them to ensure their safety and effectiveness.
Article 6 the classification of in vitro diagnostic reagents shall be determined according to the following rules:
（1） Class I in vitro diagnostic reagents
1. microbial culture medium that is not used for microbial identification or drug sensitivity test, and cell culture medium that is only used for cell proliferation culture, does not have the function of cell selection, induction and differentiation, and the cultured cells are used for in vitro diagnosis;
2. products for sample treatment, such as hemolytic agent, diluent, staining solution, nucleic acid extraction reagent, etc;
3. general reagents for reaction system, such as buffer solution, substrate solution, enhancement solution, etc.
（2） Class II in vitro diagnostic reagents
In addition to the in vitro diagnostic reagents that have been identified as class I and class III, others are class II in vitro diagnostic reagents, mainly including:
1. reagents for protein detection;
2. reagents for sugar 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 the detection of drugs and drug metabolites;
9. reagents for autoantibody detection;
10. reagents used for microbial identification or drug sensitivity test, and cell culture medium used for cell proliferation culture, which has the functions of selecting, inducing and differentiating cells, and the cultured cells are used for in vitro diagnosis;
11. reagents for allergy (allergen) detection;
12. reagents used for the detection of other physiological, biochemical or immune function indicators.
（3） Class III in vitro diagnostic reagents
1. reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens;
2. reagents related to blood type and tissue matching;
3. reagents related to human gene detection;
4. reagents related to genetic disease detection;
5. reagents related to the detection of narcotic drugs, psychotropic drugs and toxic drugs for medical use;
6. reagents related to the detection of therapeutic drug action targets and reagents for concomitant diagnosis;
The accompanying diagnostic reagent is a tool used to evaluate the safety and effectiveness of relevant medical products. It is mainly used to identify patients who are most likely to benefit from relevant medical products before and / or during treatment and patients who may increase the risk of serious adverse reactions due to treatment. Reagents used for the detection of drugs and drug metabolites do not belong to the accompanying diagnostic reagents.
7. reagents related to tumor screening, diagnosis, auxiliary diagnosis, staging, etc.
Article 7 the classification of in vitro diagnostic reagents shall also be comprehensively determined in combination with the following situations:
（1） Class II in vitro diagnostic reagents listed in Article 6, such as those used for tumor screening, diagnosis, auxiliary diagnosis, staging, etc., or for genetic disease detection, shall be managed in accordance with class III in vitro diagnostic reagents.
（2） Reagents used for the detection of drugs and drug metabolites, if the drugs fall within the scope of narcotic drugs, psychotropic drugs or toxic drugs for medical use, shall be managed in accordance with category III in vitro diagnostic reagents.
（3） The calibrators and quality control materials used in conjunction with class I in vitro diagnostic reagents shall be managed according to class II in vitro diagnostic reagents; The calibrators and quality control products used with the second and third in vitro diagnostic reagents shall be managed according to the same category as the reagents; Multiple calibrators and quality control samples shall be managed according to the high category.
（4） Antibody reagents for flow cytometry, antibody reagents for immunohistochemistry, probe reagents for in situ hybridization and lymphocyte subgroup analysis kits for flow cytometry with definite diagnostic value shall be managed according to class II or class III in vitro diagnostic reagents according to the provisions of Article 6 according to their intended clinical use.
The single antibody reagent for flow cytometry, single antibody reagent for immunohistochemistry and single probe reagent for in situ hybridization, as well as the same type control antibody reagent for flow cytometry, which only provide auxiliary diagnostic information for professional doctors, shall be managed according to class I in vitro diagnostic reagent.
（5） If the products used for sample treatment in the first category of in vitro diagnostic reagents listed in Article 6 are non general products, or participate in the reaction and affect the test results, they shall be consistent with the management category of the corresponding test reagents.
Article 8 the catalogue of in vitro diagnostic reagents shall be formulated and published by the SDA. According to the production, operation and use of in vitro diagnostic reagents, the SDA timely analyzed and evaluated the risk changes of in vitro diagnostic reagents, and adjusted the classification catalogue of in vitro diagnostic reagents.
For the newly developed in vitro diagnostic reagents that have not been listed in the classification catalogue of in vitro diagnostic reagents, the applicant can directly apply for the product registration of category III in vitro diagnostic reagents, or judge the product category according to the classification rules and apply for classification and definition according to the classification and definition workflow of medical devices.
Article 9 The SDA may organize the Technical Committee for the classification of medical devices to formulate and adjust the classification catalogue of in vitro diagnostic reagents.
Article 10 these Rules shall come into force as of the date of promulgation. If the classification principles of in vitro diagnostic reagents in the previously issued documents are inconsistent with these rules, these Rules shall prevail.