How much do you know about the business requirements of in vitro diagnostic reagents?

In vitro diagnostic reagent management is divided into medical device management and drug management. Here we mainly explain the in vitro diagnostic reagents for the management of medical devices: including reagents, kits, calibrators, quality controls and other products that can be used for in vitro detection of human samples in the process of disease prediction, prevention, diagnosis, treatment monitoring, prognosis observation and health status evaluation. It can be used alone or in combination with an instrument, appliance, device or system. In vitro diagnostic reagents for drug administration are those used for blood source screening and labeled with radionuclides.

Classification of in vitro diagnostic reagents
In vitro diagnostic reagents are also divided into three categories and nine, according to the degree of risk of medical devices, medical device management to implement classification management. At the same time as medical devices, the operation of class I in vitro diagnostic reagents does not require licensing and filing, the operation of class II in vitro diagnostic reagents is subject to filing management, and the operation of class III in vitro diagnostic reagents is subject to administrative licensing management.

The first category of products: microbial culture medium (not used for microbial identification and drug sensitivity test); Products for sample processing, such as hemolytic agent, diluent, staining solution, etc.

The second category of products: except for the products that have been clearly defined as the third category and the first category, the others are the second category of products, mainly including: reagents for protein detection; reagents for sugar detection; reagents for hormone detection; reagents for enzyme detection; reagents for ester detection; reagents for vitamin detection; reagents for inorganic ion detection; reagents for drug and drug metabolite detection; reagents for drug and drug metabolite detection; reagents for autoantibody detection; Reagents for microbial identification or drug sensitivity test; Reagents for the detection of other physiological, biochemical or immune function indicators.
The third category of products: reagents related to the detection of pathogenic pathogen antigens, antibodies and nucleic acids; reagents related to blood type and tissue matching; reagents related to human gene detection; reagents related to genetic diseases; reagents related to the detection of narcotics, psychotropic drugs and toxic drugs for medical use; reagents related to the detection of therapeutic drug targets; reagents related to the detection of tumor markers; agents associated with allergies (allergens).

Business demand for in vitro diagnostic reagents

Requirements for (I) operators:
1. The person in charge of the enterprise should have a college degree or above, and be familiar with the national laws, regulations, rules and knowledge of in vitro diagnostic reagents.

There should be quality management personnel suitable for the scale of operation, and the quality management personnel should exercise the quality management function and have the right to rule on the quality of diagnostic reagents. One of them is a competent inspector, or has a university degree or above in laboratory science and has been engaged in inspection-related work for more than 3 years. Quality management personnel should be on-the-job, not part-time.

3. Acceptance and after-sales service personnel should have a Secondary specialized school degree or above in inspection science; corporate custody, sales and other staff should have a Senior high school or Secondary specialized school education level.

4. Personnel in quality management, acceptance, storage, sales and other jobs shall receive induction training and pass the examination before taking up their posts.

Requirements of (II) System and Management
1, should be in accordance with the medical device management laws and regulations and related documents to develop in line with the actual quality management documents, including quality management system, responsibilities, work procedures.

2. The quality management system should include: the management of quality management documents, the regulations of internal review, the regulations of quality veto, the management of diagnostic reagent purchase, acceptance, storage, sales, delivery, transportation and after-sales service, the management of the validity period of diagnostic reagents, the management of unqualified diagnostic reagents, the management of returned diagnostic reagents, the management of facilities and equipment, the management of personnel training, and the management of personnel health status, computer information management.

3, quality management responsibilities should include: quality management, purchase, acceptance, storage, sales, transportation, after-sales service, information technology and other responsibilities.

4. The working procedures shall include: procedures for the management of quality management documents, procedures for the purchase, acceptance, storage, sales, delivery, transportation and after-sales service of diagnostic reagents, procedures for the return of diagnostic reagents after sales, and procedures for the confirmation and handling of unqualified diagnostic reagents.

5, should establish the purchase, acceptance, sales, delivery, transportation and other content of the quality management records.

(III) Facilities and Equipment Requirements
1. There should be bright and clean office and business premises, and the area should be compatible with the scale of operation, but not less than 100 square meters.

2, should be set up to meet the requirements of diagnostic reagent storage warehouse, its area should be adapted to the scale of operation, but not less than 60 square meters, and the reservoir area environment is clean and clean, no pollution sources; Diagnostic reagent storage operation area should be effectively isolated from other areas such as operation and office. The interior walls, roofs and floors of the warehouse shall be smooth and flat, and the doors and windows shall be tightly structured. Residential premises shall not be used as a warehouse.

A cold storage for storing diagnostic reagents should be set up, and its volume should be compatible with the scale of operation, but not less than 20 cubic meters. Cold storage should be equipped with automatic monitoring, regulation, display, recording temperature conditions and automatic alarm equipment, standby generator set or the installation of dual circuit, standby refrigeration unit.

4, there should be with the scale of operation and business varieties, in line with the diagnostic reagent storage temperature and other characteristics of the transport facilities and equipment.

5. There should be a computer management information system, which can meet the relevant requirements of the whole process of diagnostic reagent management and quality control, and has the conditions to accept the supervision of the local food and drug supervision and administration department.

6, should be used to check the facilities and equipment, maintenance, calibration, repair, clean file.

(Information from China In Vitro Diagnostic Network)