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.

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 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.

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.

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.

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.

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.

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.

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.

Discussion on the Sterilization Material in the Registration Evaluation of Sterile Medical Device / 中国医疗器械杂志

This article first introduces the regulation requirements for sterilization material in the registration evaluation of sterile medical devices. Secondly, the article chooses the suture passer set kit with multiple sterilization methods as an example product for technical evaluation. The article hopes to provide a reference for the applicant who prepare the registration material and the technical evaluators how to make the evaluation for the medical device registration.

Analysis and Improvement Suggestions on Change of Medical Devices Licensing Items / 中国医疗器械杂志

Based on the statistics of 350 technical evaluations of changes in licensing items of class Ⅱ passive and active medical devices completed in Henan province from July 2017 to November 2018, this paper summarized and analysed the common problems and requirements listed in the correction notifications of the technical evaluation, and put forward relevant countermeasures or suggestions, with a view to further speeding up the evaluation and approval of medical devices.

Discussion on Technical Evaluation of Magnetocardiography / 中国医疗器械杂志

There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.

Status Analysis and Improvement Suggestions on the Renew Registration of Passive Medical Devices / 中国医疗器械杂志

The article collected 250 renew registration of domestic Class Ⅱ passive medical devices from Jan. 2016 to Aug. 2017 in Shanghai. It summarized the common problems listed in the correction notifications of the technical evaluation, and then provides some relevant countermeasures or suggestions. So that we can further speed up the evaluation and approval of medical devices.

ADAPTACIÓN DE UNA METODOLOGÍA PARA LOS PROCESOS DE ADQUISICIÓN DE SISTEMAS DE AIRE ACONDICIONADO EN SERVICIOS DE SALUD / ADAPTATION OF A METHODOLOGY FOR PROCUREMENT PROCESSES OF AIR CONDITIONING SYSTEMS IN HEALTH SERVICES / ADAPTAÇÃO DE UMA METODOLOGIA PARA OS PROCESSOS DE AQUISIÇÃO DE SISTEMAS DE AR CONDICIONADO NOS SERVIÇOS DE SAÚDE

La adquisición efectiva de tecnologías en salud está enfocada al mejoramiento de la calidad y eficiencia, en la prestación de los servicios de salud ya que es un proceso complejo. Dentro de este proceso se destacan la evaluación técnica y clínica. El objetivo de la evaluación de tecnologías en salud es recolectar, analizar y sintetizar información y conocimiento para contribuir a mejorar la toma de decisiones en la práctica médica y en las políticas de salud. En este trabajo se presenta una evaluación en procesos de adquisición de sistemas de aire acondicionado en servicios de salud, basada en la definición de variables en campos de evaluación; dichas variables cuantifican lo técnico y funcional del equipo en su entorno clínico y económico. De igual manera, se pretende impulsar en los departamentos de ingeniería clínica la implementación de metodologías de amplia aceptación y efectividad que tienen como objetivo primordial la adquisición de tecnologías en salud basados en la evidencia.

The effective acquisition of health technologies is focused on improving the quality and efficiency in the provision of health services as it is a complex process. Within this process the technical and clinical evaluation are highlighted. The objective of the health technology assessment is to collect, analyze, and synthesize information and knowledge to help improve decisionmaking in medical practice and health policy. This paper presents an evaluation process of acquiring air conditioning systems in health care facilities, based on the definition of variables into a field evaluation; these variables quantify the technical and functional team in their clinical and economic environment. Similarly, it is intended to promote in clinical engineering departments, the implementation of widely accepted methodologies and effectiveness that have, as its primary objective, the acquisition of technologies in evidence-based health.

A aquisição efetiva das tecnologias da saúde é focada na melhoria da qualidade e eficiência na prestação de serviços de saúde, pois é um processo complexo. Dentro deste processo se destaca a avaliação técnica e clínica. O objetivo da avaliação de tecnologias em saúde é coletar, analisar e sintetizar informações e conhecimentos para ajudar a melhorar a tomada de decisão na prática médica e a política de saúde. Neste trabalho se apresenta um processo de avaliação de aquisição de sistemas de ar condicionado nos serviços de saúde, com base na definição de variáveis no campo da avaliação; essas variáveis vão quantificar o técnico e o funcional do equipamento em seu ambiente clínico e econômico. Da mesma forma, pretende-se promover nos departamentos clínicos de engenharia a aplicação de metodologias amplamente aceitas e eficácia que têm como objetivo principal a aquisição de tecnologias em saúde baseada em evidências.

EVALUACIÓN TÉCNICA Y CLÍNICA DE TECNOLOGÍA BIOMÉDICA EN PROCESOS DE ADQUISICIÓN: UN ENFOQUE EN EVALUACIÓN DE TECNOLOGÍAS EN SALUD

La adquisición de tecnologías en salud es un proceso complejo enfocado al mejoramiento en la calidad y la eficiencia en la prestación de los servicios de salud a través de la adquisición de tecnología efectiva. Dentro de los procesos de adquisición de tecnologías en salud se destacan la evaluación técnica y clínica. El objetivo de la evaluación de tecnologías en salud es recolectar, analizar y sintetizar información y conocimiento para contribuir a mejorar la toma de decisiones en la práctica médica y en las políticas de salud. Este artículo ofrece un procedimiento de adquisición de tecnología biomédica con énfasis en la evaluación técnica y clínica basado en metodologías de evaluación de tecnologías en salud. También ofrece una estructura detallada sobre los conceptos técnicos y clínicos que servirán de base para la toma de decisiones en procesos de adquisición dentro del ambiente prestador de salud. De igual manera, pretende impulsar en los departamentos de ingeniería clínica la implementación de procesos metodológicos de amplia aceptación y efectividad que tienen como objetivo primordial la adquisición de tecnologías en salud basados en la evidencia. Asimismo, se promueve la participación activa del personal asistencial y técnico con el fin de enfocar el proceso a un ambiente multidisciplinario y obtener retroalimentación específica sobre las tecnologías en salud en áreas de uso a través de usuarios representativos.

The acquisition of healthcare technologies is a complex process focused in the improvement of quality and efficiency in delivering health services through the acquisition of technology in an effective manner. Within the acquisition processes of healthcare technologies, the technical and clinical evaluation highlights. The objective of the health technology assessment is to collect, analyze and synthesize information and knowledge to help improve decision-making in medical practice and health policies. This article provides a procedure for healthcare technologies acquisition with emphasis in technical and clinical evaluation based on health technology assessment methodologies. This presents a detailed structure on technical and clinical concepts that serve as a basis for decision-making procurement processes within healthcare environment. Likewise, it is expected to motivate in clinical engineering departments, the implementation of broad acceptance and effective methodological process that have as its primary objective the acquisition of healthcare technologies based on evidence. It also promotes the active participation of clinical and technical staff in order to approach the process to a multidisciplinary environment and obtain feedback on specific areas of the healthcare technologies trough representative users.