【精确转码】欧美医疗器械管理经验及对中国医疗器械法规体系改革的启示_孙勤.docxVIP

Chinese Journal of Medical Instrumentation?监管与测试2006年30卷第1期■ ?义章编号：1671-7104(2006)0 卜0043-10欧美医疗器械管理经验 及对中国医疗器械法规体系改革的启示【作者】孙勤严梁上海市食品药品监督管理局医疗器械注册处【摘要】飞速发展的医疗器械提高了无数人的生活质量或挽救了他们的生命.但同时医疗器械不良事件曰益增多.各国政府对此都 十分重视。我国于2000年颁布了 医疗器械监督管理条例开始实行医疗器械市场准入制度.这在很大程度上提高了 产品的安全性和有效性 但由于缺乏对上市后和使用中的医疗器械的有效监管.大量的假冒伪劣产品仍然存在。因此.改 进现行的医疗器械管理体系.成了当务这急。一些发达国家.如美国和欧盟数十年对安全、风险变化的研究.已经建立了一个相对完善的医疗器械管理体系。分析 才欧盟、美国和中国的医疗器械法规体系■包括医疗器械监督管理法规的实质性要求及其实际执行.介绍了欧美的管理经 验.目的是希望对我国的医疗器械管理体系改革有所启示。【关键词】医疗器械法规、安全、有效、比较研究、改革 【中图分类号】C931.2 【文献标识码】ABetter Medical Devices Regulations for Better Health Care: Enlightenment for Medical Devices Regulatory Reform in China, from Experiences of the EU and the USA【Writers ] SUN Qin.YAN LiangMedical Devices Registration Department, Shanghai Municipal Food Drug Administration【Abstract 】Theexpansion of applications of medical devices has attracted the increased attention of government regulatory bodies around the world to the safety and effectiveness of these products. Most developed countries, such as the United States and European Union, have developed well-established regulatory systems for medical devices，which have also consistently been amended to accommodate the changing requirements of safety and the trend of globalization.The current Regulations for the Supervision and Administration of Medieal Device (China)*, established in 2000, has brought about great improvements for the safety and effectiveness of products, safeguarding public health. But there are still, at present, a lot of counterfeit and poor quality devices and device-related adverse events for lack of powerful post -market and in-use regulatory controls for products. It is therefore very urgent for the Chinese government to reform its medical device administration and management. This research paper analyses and compares the different requirements and executions of medical devices regulations in the EU, the US and China, to draw some experiences of the EU and US regimes that are very useful to Chin