1.Analysis of focus points in the review and evaluation of Blood Infusion Devices
Chenghong YE ; Li XIAO ; Yuxi YANG ; Liyu LI ; Juntai ZHU
China Medical Equipment 2025;22(9):139-142
Hemoperfusion device is widely used in the field of blood purification because of its good adsorption properties to some substances in the body.By combing the principle,structure and other characteristics of the hemoperfusion device,searching the approval status of the currently listed products,this paper summarized the main application fields,application scenarios and research frontiers of the hemopoeia product,combined with the current status of the product declaration and product characteristics,and discussed the main concerns of product review,such as product chemical residue and its risk assessment methods,performance verification,etc.In order to provide reference for the product development of relevant product development institutions and the supervision of regulatory agencies.
2.Analysis of focus points in the review and evaluation of Blood Infusion Devices
Chenghong YE ; Li XIAO ; Yuxi YANG ; Liyu LI ; Juntai ZHU
China Medical Equipment 2025;22(9):139-142
Hemoperfusion device is widely used in the field of blood purification because of its good adsorption properties to some substances in the body.By combing the principle,structure and other characteristics of the hemoperfusion device,searching the approval status of the currently listed products,this paper summarized the main application fields,application scenarios and research frontiers of the hemopoeia product,combined with the current status of the product declaration and product characteristics,and discussed the main concerns of product review,such as product chemical residue and its risk assessment methods,performance verification,etc.In order to provide reference for the product development of relevant product development institutions and the supervision of regulatory agencies.
3.Discussion on key points for second type of medical sodium hyaluronate wound dressing
Yongxia CHEN ; Juntai ZHU ; Ruiqi MAO ; Wei SHI ; Deshuang GOU
International Journal of Biomedical Engineering 2024;47(4):411-414
With the development of the medical cosmetology industry, the market demand for medical sodium hyaluronate dressing is gradually increasing, but at present the product lacks the corresponding national standards. This problem makes this type of product face the problem of non-uniform standards in the quality control, registration declaration information content, technical review requirements, and other aspects. In this review paper, the classification of medical sodium hyaluronate wound dressing products was introduced, and the key points of the technical review were discussed, involving the division of the registration unit, raw material control, product performance indicators, and clinical evaluation. In addition, the key information review requirements in the process of registration and declaration of such products were analyzed, with a view to providing technical references for manufacturers and relevant regulatory agencies.
4.Consideration of Application Supervision of Reuse of Disposable High-pressure Contrast Injector.
Chinese Journal of Medical Instrumentation 2021;45(5):539-541
With the popularization of angiography and enhanced scanning in China, high pressure contrast injector is widely used in CT, MRI, DSI and so on, the authors team try to explore and consider the harmfulness and countermeasures of the reuse of the disposable high-pressure contrast injector from the perspective of medical device supervision. Hope that it's helpful to this registration and technical evaluation.
China
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Contrast Media
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Injections
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Magnetic Resonance Imaging

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