浅谈如何做好医疗器械注册工作

本文介绍了我国医疗器械注册的有关法规与要求,并结合笔者自身申报注册经验简要介绍境内二类医疗器械注册的有关程序、要求及注意事项,并对做好相关工作提出建议。     

风险分析在医疗器械中的应用简介

介绍了对医疗器械进行风险分析的概念和国外医疗器械风险分析的发展过程 ,强调了对医疗器械进行风险分析的重要性。概括介绍了第一联合工作组(JWG1)对医疗器械风险管理活动的步骤框架和风险评估程序     

FDA医疗器械指南开发程序介绍

目的：通过对FDA医疗器械指南开发程序的研究,为建立我国医疗器械指南管理提供借鉴。方法：采用指南文件翻译和分析方法,主要资料来源于美国食品药品管理局网站上已发布的医疗器械相关指南及相关法规文件。结果与结论：FDA对医疗器械指南进行分类管理,在21C F R中明确了良好指南管理规范的要求,并有专门的“规范的指南开发程序”。我国应以此为借鉴,制定符合我国国情的医疗器械指南开发程序,完善我国医疗器械指南编写和管理工作,为提升我国医疗器械行业技术要求和管理水平提供保障。     

关于医疗器械科学监管模式的探讨

本文通过对我国医疗器械监管现状的介绍及对目前医疗器械监管中出现的问题分析，提出了对医疗器械科学监管的建议，以期达到保证医疗器械安全、有效，保障人体健康和生命安全的目标。     

美国 FDA 医疗器械召回

本文介绍了美国食品药品监督管理局(FDA)实施医疗器械产品召回的一般程序、FDA在医疗器械召回中的职责,以及召回组织在向FDA进行医疗器械召回报告时应该提供的内容,为我国<医疗器械召回管理办法(试行)>的施行提供借鉴.     

俄罗斯对医疗器械市场准入的要求

介绍了俄罗斯医疗器械法规要求,以及负责医疗器械监管的相关部门,并简要介绍了俄罗斯医疗器械市场准入所需要注册程序和认证要求。     

日本罕见病用医疗器械上市激励政策研究及启示

目的：通过分析日本罕见病用医疗器械上市激励政策，为我国罕见病用医疗器械的上市激励发展提供经验借鉴。方法：采用文献调研法，通过梳理日本罕见病用医疗器械的定义、申请资料、认定程序和激励细则，与我国罕见病用医疗器械发展现状作对比，找出我国罕见病用医疗器械发展的不足之处并提出相应完善建议。结果：与日本相比，我国罕见病用医疗器械缺少专项立法，现有政策细则不够完善，对于罕见病用医疗器械的上市激励力度不足。结论：建议完善罕见病用医疗器械的激励措施，并进行细化，逐步形成罕见病用医疗器械的认定体系，提供一定的财政支持，助力我国罕见病用医疗器械的发展。     

美国对高风险医疗器械的审批

在各国对医疗器械进行监督管理的实践中,监管的严格程度和需要通过的法规程序是根据医疗器械的风险等级来确定的。该文简要介绍了美国对高风险医疗器械进入市场的法规要求。     

台湾医疗器械监管概述

本文对台湾医疗器械定义、法规体系及标准、监管机构和上市前审查等方面进行了介绍，为进一步加强我国医疗器械监管能力、完善医疗器械监管制度提供借鉴。     

医疗器械邀请招标的组织

本文简要介绍了医疗器械邀请招标的组织程序，评标原则、方法、内容、标准、要求和注意事项，具有较强的操作性。     

浅析医疗器械质量管理体系对厂房设施和环境的要求

本文简单介绍了中国医疗器械质量管理体系规范、欧盟医疗器械指令、ISO13485标准和美国FDA对厂房设施和环境的要求,并进行了简单的比较,目的是为医疗器械制造商在理解相关法规时,提供借鉴.     

美国FDA对医疗器械标识的要求

分析了标识对医疗器械的重要性，介绍了美国FDA对医疗器械标识的要求，包括通用要求以及对体外诊断试剂产品，临床研究用器械、510（K）、GMP、以及辐射类器械的特定要求。     

质量体系对医疗器械标签、说明书和包装的要求探究

本文概括性地介绍了中国、美国医疗器械质量体系法规和ISO13485：2003标准对医疗器械标签、说明书和包装的控制要求,从质量体系的角度分析了对医疗器械标签、标识和包装的控制,从形式和内容方面比较了这些要求的异同,便于医疗器械制造商在实施质量体系时进行全面的考量。     

浅析医疗器械质量体系对厂房设施和环境的要求

介绍了中国医疗器械质量体系规范、欧盟医疗器械指令、ISO13485标准和美国FDA对厂房设施和环境的要求,并进行了简单的比较,为我国医疗器械制造商在理解相关法规时提供借鉴。     

Managing medical device hazards and recalls. ECRI's guide for setting up an effective program

Each year, healthcare facilities are confronted with hundreds of medical device hazard reports and recalls. To ensure that appropriate actions are taken in response to all such reports, facilities must have an effective medical device hazard and recall management program in place. Such a program should ensure that hazard and recall information is received and communicated to the appropriate personnel and that the required action is taken and documented. This Guidance Article was developed to serve as a resource for healthcare facilities that wish to set up--or, more likely, refine--a hazard and recall management program. We have divided the discussion into three sections: The first part of this article addresses the role that hazards and recalls play in improving patient safety, focusing on the U.S. Food and Drug Administration's (FDA) role in the recall process and on healthcare facilities' responsibility to deal with hazards and recalls. The second part guides hospitals through the process of setting up an effective in-house hazard and recall management program. In the final section, we review some of the ECRI resources and tools you can use to develop and refine your program.     

Facilities strive to comply with new Act. The long-term effects of the Safe Medical Devices Act are still unknown

Unlike previous medical device laws, the Safe Medical Devices Act of 1990 (SMDA), which became effective November 28, 1991 applies to "device-user facilities" such as hospitals and long-term care facilities. Final regulations are scheduled for release later this spring. The SMDA's primary goals are to: Ensure all devices currently in or entering the marketplace are safe and effective Enable the U.S. Food and Drug Administration (FDA) to learn quickly about serious problems with medical devices Remove defective devices (old and new) from the market To achieve these goals, Congress has given the FDA new review and enforcement powers, including the authority to impose fines on those in violation of the law. Incidents in which a medical device caused or contributed to the death, serious illness, or serious injury of a patient are referred to as medical device-reportable (MDR) events. A user must report MDR deaths to the FDA and to the manufacturer (if known). Serious illnesses and serious injuries caused by or attributed to the use of a device must be reported to the device manufacturer or, if the manufacturer is unknown, to the FDA. Facilities must report MDR events to the FDA semiannually and maintain incident files for two years after reporting the MDR event. The FDA may assess civil penalties against parties that do not comply with the SMDA's reporting provisions. Healthcare facilities must develop and implement employee training and education programs to help physicians, nurses, and other allied health employees identify and report MDR events.     

美国FDA2012财年医疗器械注册新变化

近日美国FDA公布了其2012财年的医疗器械产品注册收费标准和工作目标.本文对比了FDA2011财年的收费标准和以往的工作目标,发现各项收费均有所下调,而审批的时间全面增加.     

美国医疗器械法规介绍

文章首先介绍了FDA的机构组成,着重阐述了医疗器械在美国上市的两个途径,以及FDA是如何通过质量体系来控制和监管医疗器械生产厂的,最后简单的介绍了美国的临床试验申请和产品上市后监督的一些法规情况.