We found that the number of institutions made use of the undocumented in vitro diagnostic reagent in the survey. The phenomenon poses some risks and problems. In use this paper, we analyzed the situation and the reasons for the use of the undocumented in vitro diagnostic reagents, and put forward the corresponding measures.
Humans ; Indicators and Reagents ; standards

OBJECTIVE: This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device. METHODS: This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020. RESULTS: The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance. CONCLUSIONS It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.
Indicators and Reagents ; Marketing ; Reference Standards

From the perspective of technical review, this paper made statistics on the supplement contents of
Chemistry, Clinical/standards* ; China ; Indicators and Reagents ; Reagent Kits, Diagnostic/standards*

In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.
Allergens ; European Union ; Indicators and Reagents ; Marketing ; Reference Standards

By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Clinical Trials as Topic ; Equipment and Supplies/standards* ; Indicators and Reagents/standards* ; Reproducibility of Results ; Research Design/standards*

OBJECTIVEIn order to adapt the rapid development of modern medicine, this paper is aimed to analyze the application of in vitro diagnostic reagents (IVD Reagents) in hospital management and improve the overall level of hospital management.

METHODSBy groping the management experience of IVD reagents, we discuss the internal hospital management mode of IVD reagents in reality.

RESULTSWith the continuous improvements on the information platform of IVD reagents,we can realize benefit analysis of IVD reagents within the process of management.

CONCLUSIONReasonable management on IVD reagentscan improve the working efficiency in hospitals and provide swifter and better medical service for patients.

The regulatory history and status of in vitro diagnostic reagents (IVD) at home and abroad are introduced. Suggestions are also provided on the administration of IVD.
Diagnostic Techniques and Procedures ; instrumentation ; Health Services Administration ; Indicators and Reagents ; standards ; Product Surveillance, Postmarketing

The reagent RBC of known blood group is indispensable reagent for detecting antibody in serological identification of ABO blood group. To elevate the accuracy of detection and solve problems for standardization and quality control of prepared reagent RBC, the detection of specificity and affinity of reagent RBC, shaking test, flow cytometry and atomic force microscopy were performed. On the basis of screening and establishing the reagent for quality control, methods for quality inspection and quality control were established. The results indicated that the prepared reagent RBC evaluated in three batches ensured the quality and performance, and decreased the variance between different batches of the products to the utmost. In conclusion, the quality control problems of prepared reagent RBC had been solved and the accuracy of detection for blood types also elevated.
ABO Blood-Group System ; Blood Grouping and Crossmatching ; standards ; Erythrocytes ; immunology ; Humans ; Indicators and Reagents ; Quality Control

In this paper, the procedures, logos, methods, essentials as well as notable problems for inspecting the qualification management system of in vitro diagnostic regent manufactures are discussed, with aims of promoting inspector's practical level and consequentially ensuring the quality, standard and efficacy of the inspection.
Diagnostic Techniques and Procedures ; instrumentation ; Indicators and Reagents ; standards ; Quality Assurance, Health Care ; Quality Control

OBJECTIVETo explore the current state and the mainly typical problems and vulnerable parts existed in the quality management systems (QMS) of local in vitro diagnostic reagent manufactures.

METHODTo statistical analyze the problems found in the quality management system of in vitro diagnostic reagent manufactures through inspection organized by CCD, SFDA during the second half year of 2011.

RESULTSThe total level of the QMS of local IVD manufacturers has risen greatly in past recent years, but a lot of problems still existed. The main vulnerable issues existed in QMS of IVD are documentation and recorder control, design control and validation, producing process control, as well as monitoring and quality control etc, to which should be paid more attention in the future improvement made by the enterprises and supervision by the administration authorities.