On March 19, 2021, the National Medical Products Administration(NMPA) issued the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of in vitro diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad, combined with the Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed in vitro diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.
China ; Quality Control ; Indicators and Reagents/standards* ; Reagent Kits, Diagnostic/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

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*

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*

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

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.

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.

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

OBJECTIVE: To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for determination of Hg in biological samples. METHODS: The samples were digested with microwave digestion instrument. ICP-MS was applied to detect Hg in blood, urine and hair specimens by using 115In as an internal marker. The ability of gold to eliminate the memory effect of mercury was investigated with the gold amalgamate produced by gold and mercury. RESULTS: The limits of detection were in the 0.01 microg/L, and the accuracy of the method ranged from 97.0% to 107.1%. The concentration of gold was 10 microg/L and the memory effect of mercury was resolved. CONCLUSION The method is accurate, rapid, sensitive and suitable for the cases of mercury poisoning and the clinical diagnosis and monitoring for patients with mercury poisoning.
Forensic Toxicology ; Hair/chemistry* ; Humans ; Indicators and Reagents ; Mass Spectrometry/methods* ; Mercury/urine* ; Mercury Poisoning/diagnosis* ; Microwaves ; Reference Standards ; Reproducibility of Results ; Sensitivity and Specificity ; Specimen Handling/methods*