[Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation].

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

[Analysis of Key Points of Technical Review of Traditional Chinese Medicine Fumigation Treatment Device].

Traditional Chinese medicine fumigation device is the carrier of traditional Chinese medicine fumigation treatment. In recent years, with the rapid development of new technology and new materials, the development of fumigation device changes with each passing day, and a variety of new products continue to emerge. However, at present, the lack of corresponding evaluation norms, resulting in some difficulties in the registration, marketing, quality control, evaluation scale and other aspects of the product. Some products have many disadvantages in clinical use. From the perspective of technical review, this paper elaborates and analyzes the main concerns in technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc., in order to provide a basis for the design, development, production, registration, use and post-marketing supervision of the devices.

[Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle].

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

[Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine].

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

Concerns of Technical Evaluation on Registration of Disposable Endoscopic Injection Needle / 中国医疗器械杂志

From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.

Suggestions on the evaluation system of science and technology in the field of health policy and management research / 中华医学科研管理杂志

Objective:Health policy and management, and its development as a discipline, play an important role in promoting the development of medicine; however, where is no scientific and reasonable evaluation system of science and technology in practice.Here we will explore and establish a special evaluation system to this research feild.Methods:To analyze the problems, tasks and unique research methods specially solved and used in the field of health management and policy; to discuss the existing problems with theory combined with practice.Results:According to the guidance of national policy, put forward principles and some assessment indicators with their weight grading, index, and examples in detail for the academic evaluation system in the field of this field.Conclusions:Health policy and management is a kind of discipline of the category of social science that possesed the particularity of practice management. Thus, it is important that the academic evaluation should reflect the responsibilities, contributions and characteristics of this subject and the researchers.

Analysis of Factors Affecting Effectiveness of Medical Device Registration Self-inspection from Perspective of Technical Evaluation / 中国医疗器械杂志

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.

Analysis of Key Points of Technical Review of Traditional Chinese Medicine Fumigation Treatment Device / 中国医疗器械杂志

Traditional Chinese medicine fumigation device is the carrier of traditional Chinese medicine fumigation treatment. In recent years, with the rapid development of new technology and new materials, the development of fumigation device changes with each passing day, and a variety of new products continue to emerge. However, at present, the lack of corresponding evaluation norms, resulting in some difficulties in the registration, marketing, quality control, evaluation scale and other aspects of the product. Some products have many disadvantages in clinical use. From the perspective of technical review, this paper elaborates and analyzes the main concerns in technical review, such as product structure, main risks, performance requirements, clinical evaluation, etc., in order to provide a basis for the design, development, production, registration, use and post-marketing supervision of the devices.

Discussion on Technical Evaluation of Tongue Diagnosis Equipment of Traditional Chinese Medicine / 中国医疗器械杂志

This study briefly introduces the tongue diagnostic equipment of traditional Chinese medicine. It analyzes and discusses the key points of technical evaluation of tongue diagnostic equipment from the aspects of product name, performance parameters, image processing functions, product use methods, clinical evaluation, etc. It analyzes the safety risks and effectiveness indicators of tongue diagnostic equipment, hoping to bring some help to the gradual standardization of tongue diagnostic equipment and the registration of enterprises.

[Discussion on Technical Evaluation of Enzyme Electrode Biosensor Blood Glucose Meter].

Enzyme electrode biosensor blood glucose detector is a new rapid blood glucose measurement method. There is no corresponding product standard and industry standard reference at home and abroad, and there is a lack of corresponding reference experience in performance research and clinical evaluation. This study discusses the safety and effectiveness of enzyme electrode biosensor blood glucose detector from the perspective of technical evaluation of medical devices. It is expected to provide some reference for medical device registration technical reviewers and registration application enterprises.

Usefulness of BioFire FilmArray BCID2 for Blood Culture Processing in Clinical Practice.

Rapid pathogen characterization from positive blood cultures (BC) can improve management of patients with bloodstream infections (BSI). The FilmArray blood culture identification (BCID) assay is a molecular test approved for direct identification of BSI causing pathogens from positive BC. A recently updated version of the panel (BCID2) comprises improved species identification characteristics and allows for the detection of one expanded-spectrum ß-lactamase (ESBL)- and several carbapenemase-encoding genes. Here, the clinical performance of the BCID2 assay for species identification in 180 positive BCs was evaluated. BCID2 results were concordant with the standard of care (SOC) in 159/180 (88.3%) BCs; 68/74 (91.9%) and 71/74 (96.0%) of all samples growing monobacterial, Gram-positive or Gram-negative pathogens, respectively, were identified, in agreement with SOC results. Nonconcordance was related to the detection of additional pathogens by the BCID2 assay (n = 4), discrepant species identification (n = 4), or failure of BCID2 to detect on-panel pathogens (n = 1). A number (12/31; 38.7%) of discordant results became evident in polymicrobial BC specimens. BCID2 identified the presence of blaCTX-M-carrying species in 12 BC specimens but failed to predict third-generation cephalosporin resistance in four isolates exhibiting independent cephalosporin resistance mechanisms. Carbapenem resistance related to the presence of blaVIM-2 or blaOxa-48-like was correctly predicted in two isolates. In conclusion, the BCID2 assay is a reliable tool for rapid BC processing and species identification. Despite inclusion of common ESBL- or carbapenemase-encoding markers, the multifactorial nature of ß-lactam resistance in Gram-negative organisms warrants combination of BCID2 with (rapid) phenotypic susceptibility assays.

Preliminary Considerations on Management Mode and Technical Evaluation of Traditional Chinese Medicine with Same Name and Prescription / 中国实验方剂学杂志

With the publication of Registration and Classification of Traditional Chinese Medicine （TCM） and Application Data Requirements， the related management and technical documents of TCM with the same name and prescription need to be further studied and formulated. In this paper， the management mode and technical evaluation of TCM with the same name and prescription are discussed to provide reference for the formulation of management and technical documents of TCM with the same name and prescription. The issues to be discussed include which management mode to adopt， how to select the control drugs with the same name and prescription， whether the indication risk level should be divided， whether the indication should be limited to medium and low risk， and how to carry out the technical evaluation of similarity/consistency. From the perspective of technical document research and formulation， this paper mainly focuses on the technical level. However， there are still other theoretical possibilities in the management mode and technical evaluation of TCM with the same name and prescription. Therefore， this paper， as a preliminary summary of the management and technical evaluation of TCM with the same name and prescription， needs more scholars and industry experts to pay attention to and participate in this work.

[Discuss about Key Issues of Dual Energy X-ray Absorptiometry Evaluation].

The Dual energy X-ray absorptiometry is the most commonly used for measuring bone mineral density. This method involves core clinical functions, phantom and database. This article discusses the three key issues of dual energy X-ray absorptiometry evaluation, including core clinical functions, phantom and database. This article aims at helping manufacturers to scientifically carry out relevant processes during research and development and also manufacturers may refer to this article when they apply for registration.

[Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression].

Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China. The writing quality of the guidelines affects not only the time for technical evaluation, but also the safety and effectiveness of approved products. Based on authors' practices of nearly 30 class II medical equipment technical guidelines written and 20-year experience in class II medical device evaluation, this study takes intraoral digital dental impressions as an example to put forward several key points of sections "summary" and "research data" in the guidelines, for researchers on class II medical equipment technical guidelines reference.

[Exploration on Knowledge Management Construction of Medical Device Evaluation].

Knowledge management is an important method for the organization to manage information and knowledge systematically and make knowledge innovate continuously. Knowledge management includes the stages of knowledge acquisition, sharing and use, and finally achieves the goal of taking knowledge as the production factor and improving work efficiency in an organization. The core work of technical evaluation of medical devices is typical knowledge work, and the knowledge management system is of great significance to the review agency in improving work efficiency, promoting talent training, improving management level and service quality. This study briefly introduces the framework of the knowledge management system of medical device technical evaluation in the Center for Certification and Evaluation, SHFDA, and provides reference for relevant organizations to carry out knowledge management of medical device technical evaluation.

[Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation].

From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.

Exploration on Knowledge Management Construction of Medical Device Evaluation / 中国医疗器械杂志

Knowledge management is an important method for the organization to manage information and knowledge systematically and make knowledge innovate continuously. Knowledge management includes the stages of knowledge acquisition, sharing and use, and finally achieves the goal of taking knowledge as the production factor and improving work efficiency in an organization. The core work of technical evaluation of medical devices is typical knowledge work, and the knowledge management system is of great significance to the review agency in improving work efficiency, promoting talent training, improving management level and service quality. This study briefly introduces the framework of the knowledge management system of medical device technical evaluation in the Center for Certification and Evaluation, SHFDA, and provides reference for relevant organizations to carry out knowledge management of medical device technical evaluation.

Discuss about Key Issues of Dual Energy X-ray Absorptiometry Evaluation / 中国医疗器械杂志

The Dual energy X-ray absorptiometry is the most commonly used for measuring bone mineral density. This method involves core clinical functions, phantom and database. This article discusses the three key issues of dual energy X-ray absorptiometry evaluation, including core clinical functions, phantom and database. This article aims at helping manufacturers to scientifically carry out relevant processes during research and development and also manufacturers may refer to this article when they apply for registration.

Reflections on the Key Points in the Establishment of the Guidelines for Class II Medical Device Technical Review-Example of Intraoral Digital Dental Impression / 中国医疗器械杂志

Technical Review Guidelines of Medical Devices are standards to standardize and unify registration review of medical devices marketed in China. The writing quality of the guidelines affects not only the time for technical evaluation, but also the safety and effectiveness of approved products. Based on authors' practices of nearly 30 class II medical equipment technical guidelines written and 20-year experience in class II medical device evaluation, this study takes intraoral digital dental impressions as an example to put forward several key points of sections "summary" and "research data" in the guidelines, for researchers on class II medical equipment technical guidelines reference.

Design Elements of Medical Endoscope and Concerns of Registration Technical Evaluation / 中国医疗器械杂志

From the point of view of medical device registration technical evaluation, production process of endoscope, three-dimensional imaging(3D), high resolution imaging are discussed. We focus on the process of design and development, especially verification and validation. The general principle is that all risks and unexpected impacts should be minimized and acceptable to ensure that benefits are greater than risks in normal use.