The registration system of medical device Master Files is established to solve the problem that the outsourcing suppliers are not willing to cooperate with the device applicants in the process of providing medical device application documents. After a brief introduction of Master Files systems established by foreign regulatory agencies, this article focuses on the research of establishing a medical device Master Files registration system in China. The results show that the establishment of Chinese Master Files registration system can both improve the standardization and convenience of outsourcing activities of medical devices, and satisfy the needs of the development of medical device industry and regulatory system. At the same time, the probability of additional risk caused by the implementation of the system is low. Therefore, it is expected that the benefits of the system to promote public health outweigh the potential risks, which demonstrates that establishment of the system has important application values.
China ; Industry ; Reference Standards

OBJECTIVE: Thinking on the construction of the medical device type archives information system. METHODS: This paper introduces the concept and significance of medical device variety archives, and puts forward the overall construction idea and system framework of medical device variety archives by analyzing its construction difficulties. RESULTS: Considering the long-term nature and complexity of the construction of medical device variety archives, the system can be constructed in accordance with the three steps of system building, platform building and data management, and the overall technical architecture can be designed from the eight aspects of user layer, business application layer, application support layer, data resource layer, infrastructure layer, security, standards and operation and maintenance management. CONCLUSIONS Architecture design is the foundation of system construction, and its design rationality is very important for the success of system construction. The architecture design proposed in this study has a certain reference role for promoting the construction of medical device variety archives management system.
Information Systems ; Reference Standards

The rapid development of high-speed railway in China has proposed higher requests for the comfort level of high-speed trains. However, there is no internationally unified evaluation criterion for high-speed train comfort currently, which therefore substantially affects the comparability and standardization of research results for high-speed train comfort. This paper systematically reviews the research literature about evaluation indicators and standards related to high-speed train comfort, and finds that there is currently no unified definition, evaluation indicators, as well as evaluation criterion for high-speed train comfort. Most current evaluation criteria are based on a single indicator. Some indicators are simultaneously developed by different apartments and differ between each other, and there is no comprehensive indicator or criteria for high-speed train comfort, restricting the comparison of high-speed train comfort across regions. It is recommended that the administrative department of high-speed railroad in China should organize experts to establish a unified definition of high-speed train comfort, comprehensive evaluation indicators and relevant judgment criteria for high-speed train comfort, in face of the rapid development and globalization of high-speed trains.
China ; Railroads ; Reference Standards

This study is based on the summary of the characteristics of quality variation of national medical device supervision and inspection in 2020. According to the results of the national medical device supervision and inspection through comparative analysis, this study puts forward suggestions on the medical device production and supervision measures for the post-marketing products, so as to further improve the level of the medical device and ensure the safety use of medical device.
Marketing ; Reference Standards

Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.
Reference Standards ; China ; Industry

Reference Standards ; Writing

Standardisation and harmonisation of the detection of autoantibodies is important for the clinical application of autoantibodies. However, achieving complete standardisation is difficult and involves several challenges due to the complexity and particularity of autoantibody detection. Harmonisation is feasible and valued, but it involves all aspects and processes of autoantibody detection. Based on the consensus and practice of the clinical application of autoantibody detection in recent years, we discuss harmonisation in this review.
Humans ; Autoantibodies ; Reference Standards

This paper discussed the possible influence of the transformation and implementation of IEC60601-1 3rd edition in China, and accordingly proposed some preliminary suggestions.
China ; Equipment and Supplies ; standards ; Reference Standards

This paper briefly introduces the working procedure of in vitro diagnostic products (IVD) industrial standards, and elaborates the importance of professional standards for production and supervision. Based on the analysis of working progress during the past 10 years, some problems and countermeasures on project setting, participation, standard material, personnel training, work cycle are put forward, which are helpful for the future development of the IVD.
Diagnostic Techniques and Procedures ; standards ; Humans ; Reference Standards

The samples obtained from the 25 healthy adults donors, from19 to 50 years old of age, 18 men and 7 woman. Different antibodies match different methods. Standard method: CD3 (FITC) / CD16, CD56 (PE) / CD45 (PerCP) / CD19 (APC) mixture of antibodies. Estimate method: 3 colors use CD4 (FITC) / CD3 (PE) / CD8 (PerCP) mixture of antibodies and 4 colors use CD3 (FITC) / CD8 (PE) / CD45 (PerCD) / CD4 (APC) mixture of antibodies. Results: standard method - estimate method 3 colors: r = 0,85; % NK (adjust) = 1,99 x % NK (estimated) + 2,31; standard method - estimate method 4 colors: r = 0,85; % NK (adjust) = 1,63 x % NK (estimated) + 4,53
Tissue Donors ; methods ; Reference Standards