[The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder].

This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders (MAH). Through sorting and analyzing typical non-conformities, highlighting the main responsibilities of registrants, and clarifying the obligations and rights of relevant parties. Meanwhile, it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.

[A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of ].

On October 21, 2021, the National Medical Products Administration issued and implemented . The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.

[Discussion on Key Control Points and Common Problems of Molecular Diagnostic Reagents in the Process of Design and Development].

Design and development process of molecular diagnostic reagents is critical to quality management system of diagnostic reagent. Based on the technical characteristics of molecular diagnostic reagents, the study analyzed the concerned key control points and common problems in the process of design and development from the view of registration quality management system. It aimed at offering technical guidance on design and development process of molecular reagents and registration quality management system to enterprises, thus improving the product development efficiency, optimizing the quality management system, and increasing the efficiency and quality of registration and declaration.

[Features of Production Process and Risk Prevention and Control Points of Corona Virus Disease 2019 (2019-nCoV) Antigen Detection Reagent (Colloidal Gold Method)].

Corona Virus Disease 2019 (2019-nCoV) antigen detection reagent (colloidal gold method) has been applied to people who go to basic medical and health institutions for medical treatment and have respiratory tract, fever and other symptoms within 5 days, isolate observers, community residents who need antigen self-testing. The wide application of the reagent can effectively shorten the detection time, reduce the detection cost and time cost, and alleviate the pressure of nucleic acid detection. The article details the structural components, testing principles, production process and key risk points of the new coronavirus antigen test reagents, with the aim of providing a reference for the development of relevant work specifications for manufacturers, the organization of safe production and the verification and supervision of regulatory authorities.

[Study on Medical Device E-classification in China from Perspective of Innovation and Development].

With the overwhelmingly booming trend of innovation in medical devices, more and more innovative products are in urgent need of classification before marketing. Medical device classification is not only a basis of regulation but also a key factor affecting industry innovation and development. In view of the current situation of classification process in China has been time-consuming, this study discusses an E-classification framework including its classification basis, method, dimensions and technical roadmap, etc.