Rules for Classification of In Vitro Diagnostic Reagent

1.In order to standardize the classification management of in vitro diagnostic reagents, these rules are formulated according to the Regulations on The Supervision and Administration of Medical Devices.

2.In vitro diagnostic reagents mentioned in these rules refer to in vitro diagnostic reagents administered according to medical devices. In vitro diagnostic reagents for blood screening administered according to pharmaceutical products and those labeled with radionuclides do not fall within the scope of these rules.

Cell culture media products used for cell therapy, cell transfusion, assisted reproduction, etc., do not fall within the scope prescribed by these Rules.

3.This rule is used to guide the formulation and adjustment of in vitro diagnostic reagents classification catalogue and determine the new management category of in vitro diagnostic reagents.

4.The management category of in vitro diagnostic reagents should be determined according to the degree of product risk. Factors influencing the degree of risk of in vitro diagnostic reagents include but are not limited to the following:

4.1Intended use, indications, intended environment and user expertise of the product;

4.2The extent to which the information of test results affects medical diagnosis and treatment;

4.3Impact of test results on individual and/or public health.

5.In vitro diagnostic reagents are classified into category 1, category 2 and category 3 according to the degree of risk from low to high.

Category I in vitro diagnostic reagents refer to those which have low personal risk and no public health risk, and which can be guaranteed to be safe and effective by routine management. They are usually test AIDS.

The second category of in-vitro diagnostic reagents are those that present a moderate personal and/or public health risk, the test result is usually one of several determining factors, the occurrence of incorrect results will not endanger life or cause major disability, and require strict control and management to ensure their safety and effectiveness.

The third type of in vitro diagnostic reagents refers to the individual with high risk and/or public health risk, provide key information for clinical diagnosis, the result of an error on the individuals and/or pose a serious threat to public health security, need to take special measures to strictly control the management to ensure the safe and effective in vitro diagnostic reagents.

6. The classification of in vitro diagnostic reagents should be determined according to the following rules:

6.1 Class I in vitro diagnostic reagents

6.1.1 Microbial culture media not used for microbial identification or drug sensitivity test, and cell culture media only used for cell proliferation culture, do not have the function of cell selection, induction, differentiation, and cultured cells for in vitro diagnosis;

6.1.2 Sample processing products, such as hemolysis agent, diluent, dyeing solution, nucleic acid extraction reagent, etc.

6.1.3 General reagent for reaction system, such as buffer, substrate, reinforcement, etc.

6.2 The second kind of in vitro diagnostic reagent

In addition to in-vitro diagnostic reagents that have been identified as Category 1 and Category 3, the other in-vitro diagnostic reagents are category 2, mainly including:

6.2.1Reagents for protein detection;

6.2.2Reagents for the detection of sugars;

6.2.3Reagents for hormone detection;

6.2.4Reagents for enzymatic detection;

6.2.5Reagents for ester detection;

6.2.6Reagents for vitamin detection;

6.2.7Reagent for detection of inorganic ions;

6.2.8Reagents for the detection of drugs and drug metabolites;

6.2.9Reagents for the detection of autoantibodies;

6.2.10Reagents used for microbial identification or drug sensitivity test, and cell culture medium used for cell proliferation culture, which has the function of selecting, inducing and differentiating cells, and cultured cells for in vitro diagnosis;

6.2.11Reagents used for allergy (allergen) detection;

6.2.12Reagents used for the detection of other physiological, biochemical or immune function indicators.

6.3 The third kind of in vitro diagnostic reagents

6.3.1Reagents related to the detection of antigens, antibodies and nucleic acids of pathogenic pathogens;

6.3.2 Reagents related to blood type and tissue matching;

6.3.3 Reagents related to human gene testing;

6.3.4 Reagents related to the detection of hereditary diseases;

6.3.5 Reagents related to the detection of narcotic drugs, psychotropic drugs and toxic drugs for medical use;

6.3.6 Reagents related to the detection of therapeutic drug action targets and concomitant diagnostic reagents;

Concomitant diagnostic reagents are tools used to evaluate the safety and efficacy of relevant medical products and are primarily used to identify patients who are most likely to benefit from the relevant medical products and those who are at increased risk of serious adverse reactions as a result of the treatment, prior to and/or during treatment. Reagents used for the detection of drugs and drug metabolites are not concomitant diagnostic reagents.

6.3.7 Reagents related to cancer screening, diagnosis, auxiliary diagnosis, staging, etc.

7.In the classification of in vitro diagnostic reagents, the following conditions shall also be considered for comprehensive determination:

7.1 The in-vitro diagnostic reagents of category II listed in Article 6, such as those used for screening, diagnosis, auxiliary diagnosis and staging of tumors, or those used for detection of hereditary diseases, shall be administered as in-vitro diagnostic reagents of Category III.

7.2The reagents used for the detection of drugs and their metabolites, if the drugs fall within the scope of narcotic drugs, psychotropic drugs or toxic drugs for medical use, shall be administered according to class III in vitro diagnostic reagents.

7.3Calibration and quality control products used in conjunction with in-vitro diagnostic reagents of category I shall be managed according to in-vitro diagnostic reagents of Category II; Calibration products and quality control products used in conjunction with class II and Class III in vitro diagnostic reagents shall be managed in the same category as reagents; Multiple calibration products and quality control products shall be managed according to the high category among them.

7.4Antibody reagents for flow cytometry, antibody reagents for immunohistochemistry, probe reagents for in situ hybridization, and lymphocyte subsets analysis kits for flow cytometry with definite diagnostic value are administered as class II or Class III in vitro diagnostic reagents in accordance with article 6, according to their intended clinical use.

Single antibody reagents for flow cytometry, single antibody reagents for immunohistochemistry and single probe reagents for in situ hybridization, and homotypic control antibody reagents for flow cytometry, which provide diagnostic information only to professional physicians, are administered under category I in vitro diagnostic reagents.

7.5 If the products used for sample processing in the in-vitro diagnostic reagents in category I listed in Article 6 are non-general products or participate in reactions and affect test results, they shall be consistent with the management categories of the corresponding test reagents.

8.The classification catalogue of in vitro diagnostic reagents shall be formulated and published by the State Medical Products Administration. According to the production, operation and use of in vitro diagnostic reagents, the State Medical Products Administration shall timely analyze and evaluate the risk changes of in vitro diagnostic reagents, and adjust the classification catalogue of in vitro diagnostic reagents.

For newly developed in vitro diagnostic reagents not yet included in the classification catalogue of in vitro diagnostic reagents, the applicant may directly apply for the product registration of category III in vitro diagnostic reagents, or may judge the product category according to these classification rules and apply for classification and definition according to the working process of classification and definition of medical devices.

9.The NMPA may organize the Technical Committee on classification of medical Devices to formulate and adjust the classification catalogue of in vitro diagnostic reagents.

10.These rules shall take effect as of the date of promulgation. If the classification principles of in vitro diagnostic reagents in previously published documents are inconsistent with these Rules, these Rules shall prevail.