In vitro diagnostic reagent science knowledge answer (I)

With the growth of people's demand for health and disease prevention and control services, in the process of medical and health services, the public has become more and more aware of the quality and safety of diagnostic reagents. For the test results of the same project in different hospitals, there are more and more requirements for informed and quality control for the test results of the same project in different time periods of the same hospital.

At the same time, with the development of self-testing products, more and more in vitro diagnostic reagents enter family life, such as early pregnancy test and blood glucose monitoring. This application brings many differences in understanding and problems in use. There are a lot of knowledge popularization and risk control needs in product purchase, storage, application and processing, which makes it more and more necessary to carry out relevant science popularization with rich content and various forms.

While strengthening the supervision of medical devices, carrying out quality assessment and strengthening comprehensive management, the State Food and Drug Administration attaches great importance to the popularization and education of medical devices, cooperates closely with the China Medical News and Information Association, gives full play to the role of community organizations, experts and media, and develops and compiles a series of medical device science popularization knowledge materials for reference and use by food and drug regulatory agencies and media at all levels in carrying out science popularization, to help the public correctly understand medical devices such as in vitro diagnostic reagents, get out of the misunderstanding and use, improve the awareness of relevant quality and safety, effectively share the achievements of social development and scientific and technological progress, and at the same time, it is also conducive to the improvement of the quality of medical device supervision, promote the improvement of medical service ability and overall health level, and promote social co governance.

At present, most of the in vitro diagnostic reagents in China are regulated according to medical devices, and some are regulated according to drugs. The popular science knowledge introduced here mainly refers to the relevant concepts of in vitro diagnostic reagents managed by medical devices, regulatory policies and regulations, correct purchase, correct understanding of advertisements, and the use and maintenance of self-use products. "50 questions on common sense of in vitro diagnostic reagents" is an important component of popular science materials for medical devices, which has a certain guiding and helping role for readers to understand, correctly understand and apply in vitro diagnostic reagents.

Medical device science education is a long-term important work. Sincerely hope that all aspects of society will pay close attention to, participate widely, and jointly improve and progress!

1. What is a medical device?

Answer: According to the current Regulations on the Supervision and Administration of Medical Devices, medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used in the human body, including The required computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or participate in these ways but only in a supplementary role; its purpose is:

diagnosis, prevention, monitoring, treatment or mitigation of (I) diseases;

diagnosis, monitoring, treatment, mitigation or functional compensation of (II) injuries;

Examination, substitution, regulation or support of (III) physiological structures or physiological processes;

(IV) life support or maintenance;

(V) pregnancy control;

The (VI) provides information for medical or diagnostic purposes by examining samples from the human body.

Medical devices sold on the market (including and not limited to online sales and physical stores) should legally obtain a medical device registration certificate or filing certificate.

There are many kinds of medical devices, including large medical devices such as CT, magnetic resonance and other imaging equipment, syringes, surgical instruments, dentures, biochemical testing reagents, tongue depressor, condoms, etc., most of which are used by professionals in medical institutions, and some products can be used by themselves.

2. How are medical device products classified?

A: At present, China, like most countries, implements classified management of medical devices according to the degree of risk.

The first category is a low degree of risk, the implementation of regular management can ensure its safety and effectiveness of medical devices.

The second category is a medical device with moderate risk and requires strict control and management to ensure its safety and effectiveness. The third category is medical devices with high risk, which need to take special measures to strictly control and manage to ensure their safety and effectiveness.

To evaluate the risk level of medical devices, factors such as the intended purpose, structural characteristics, and use methods of medical devices should be considered.

3. What are in vitro diagnostic reagents?

Answer: According to the "Administrative Measures for the Registration of In Vitro Diagnostic Reagents" issued by my country in 2014, in vitro diagnostic reagents (IVD) managed by medical devices include in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation In the process, reagents, kits, calibrators, quality control products and other products used for in vitro detection of human samples. It can be used alone or in combination with an instrument, appliance, device or system.

Now, disease prevention, clinical diagnosis and treatment basically need to use in vitro diagnostic reagents. Whether it is the detection of hematuria and stool three regular, or the identification of virus and bacterial infection, or the examination of heart, liver, kidney and blood vessels, immune function, etc., are inseparable from in vitro diagnostic reagents.

4. Are in vitro diagnostic reagents all medical devices?

Answer: In our country, most in vitro diagnostic reagents are managed according to medical devices, and some in vitro diagnostic reagents are managed according to drugs.

According to drug management, in vitro diagnostic reagents for blood source screening and in vitro diagnostic reagents labeled with radionuclides are mainly used. These products are not medical devices.

All listed in vitro diagnostic reagents shall be registered or filed by the food and drug administration, and relevant medical device registration certificates or filing certificates shall be obtained.

5. What are the main units using in vitro diagnostic reagents?

Answer: In vitro diagnostic reagents belong to the category of medical device management. Medical device users in China refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions that have obtained the practice license of medical institutions, family planning technical service institutions that have obtained the practice license of family planning technical service institutions, and blood stations, plasma collection stations and rehabilitation assistive device adaptation institutions that do not need to obtain the practice license of medical institutions according to law.

6. Where can the public find information on in vitro diagnostic reagents?

Answer: When the public understands and identifies the relevant information of in vitro diagnostic reagent products, they can log in to the "data query" on the official website of the State Food and Drug Administration (www.cfda.gov.cn), or the official website of the food and drug supervision and administration department in the relevant region. Query relevant information, or consult the food and drug supervision and administration department.

7. How are in vitro diagnostic reagents classified?

Answer: According to the product risk level from low to high, in vitro diagnostic reagents are divided into the first category, the second category, and the third category of products.

The first category of in vitro diagnostic reagent products, including:

(1) Microbial culture medium (not used for microbial identification and drug sensitivity test);

(2) Products for sample processing, such as hemolytic agents, diluents, staining solutions, etc.

The second category of in vitro diagnostic reagent products, including:

(1) Reagents for protein detection;

(2) Reagents for the detection of sugars;

(3) Reagents for hormone detection;

(4) Reagents for enzyme detection;

(5) Reagents for the detection of esters;

(6) Reagents for vitamin detection;

(7) Reagents for the detection of inorganic ions;

(8) Reagents for the detection of drugs and drug metabolites;

(9) Reagents for autoantibody detection;

(10) Reagents for microbial identification or drug sensitivity test;

(11) Reagents for the detection of other physiological, biochemical or immune function indicators.

The third category of in vitro diagnostic reagent products, including:

(1) Reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids;

(2) Reagents related to blood type and tissue matching;

(3) Reagents related to human genetic testing;

(4) Reagents associated with genetic diseases;

(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 targets;

(7) reagents related to the detection of tumor markers;

(8) Agents associated with allergies (allergens).

8. How are the different classes of in vitro diagnostic reagents managed?

Answer: The first type of in vitro diagnostic reagents is subject to filing management, and the second and third types of in vitro diagnostic reagents are subject to registration management.

The first category of in vitro diagnostic reagents in the territory shall be filed, and the filing person shall submit the filing materials to the municipal food and drug supervision and administration department divided into districts.

The second category of in vitro diagnostic reagents in China shall be examined by the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government, and shall be issued with medical device registration certificates after approval.

The third category of in vitro diagnostic reagents in China shall be examined by the State Food and Drug Administration, and the medical device registration certificate shall be issued after approval.

9. Do imported in vitro diagnostic reagents require approval?

Answer: The first category of imported in vitro diagnostic reagents is subject to filing management. Imported in vitro diagnostic reagents of the second and third categories need to be approved before they can be sold on the market.

For the record of imported Class I in vitro diagnostic reagents, the filing person shall submit the filing materials to the State Food and Drug Administration to obtain the filing certificate.

The imported in vitro diagnostic reagents of Class II and Class III shall be examined by the State Food and Drug Administration and issued with a medical device registration certificate after approval.

The registration and filing of in vitro diagnostic reagents in Hong Kong, Macao and Taiwan shall be handled with reference to imported in vitro diagnostic reagents.

10. What is the name of the formal in vitro diagnostic reagent product?

Answer: In vitro diagnostic reagent products have clear naming requirements in China and cannot be named at will. The nomenclature of in vitro diagnostic reagents shall follow the following principles:

Product names can generally be composed of three parts. The first part: the name of the substance to be tested; the second part: use, such as diagnostic serum, assay kit, quality control, etc.; the third part: method or principle, such as enzyme-linked immunosorbent assay, colloidal gold method, etc., this part should be listed in parentheses.

If there are many components of the tested substance or other special circumstances, the indication name related to the product or other alternative name can be used.

Class I products, calibrators and quality control products shall be named according to their intended use.

The public should promptly report and consult the food and drug supervision and administration department for the relevant diagnostic products on the market that do not meet the above naming principles, so as to avoid being deceived.