简述医疗器械生产质量管理规范  

Brief on Good Manufacturing Practice for Medical Devices

作　　者：赵颖[1] 顾汉卿[1] 

机构地区：[1]天津市泌尿外科研究所,天津300211

出　　处：《透析与人工器官》2008年第4期20-27,共8页Chinese Journal of Dialysis and Artificial Organs

摘　　要：医疗器械是直接关系到人民群众身体健康和安全的特殊产品。为保障公众的安全与健康,其产品质量保证必须强化监督管理,所以医疗器械企业必须坚持"质量第一"的方针。每个国家都对医疗器械规定了一些法律法规,满足法律法规的要求是其企业生产的首要条件,法律法规将是医疗器械企业质量管理体系的基础。在国际统一的医疗器械贸易市场大环境中,我国的医疗器械监管体制要与其相融,因此学习和借鉴世界各国医疗器械质量体系管理经验,汲取精华,有利于启动我国医疗器械质量体系管理规范的制定与实施。出口的医疗器械,就必须遵循到岸国家的医疗器械指令,否则产品将不能在当地上市。大多数政府都已针对本国使用的医疗器械制订了相应的法规,以保护民众的安全。因此,本文通过借鉴美国及欧洲这两大市场的医疗器械管理规范,对我国正在逐步制定与实施的医疗器械生产质量管理规范做以综述,并在一定程度上予以了解。Medical device, as a kind of particular product, has a direct impact on human health and securi- ty. In order to ensure them it＇ s necessary to strengthen the management to the quality of products. Therefore, medical devices companies must adhere to the policy ＂quality first＂. Each country has worked out some laws and regulations to medical devices, which are the primary condition of enterprise prodution and the foundation of quality management. Under the international market enviroment on medcial devices trade Chinese management system on medcial devices should integrate with the world. Therefore, we should learn from other countries＇ experience on the quality manage- ment of medical devices, which is benefitial for establishing and complementing our goods manufacturing practice for medical devices. The exported medical devices must abey the destinatioan countries＇ rules, otherwise, they would not be allowed to put into the market in local areas. Most governments have established their own laws and regulations on medical devices so as to protect human being＇ s security. Therefore, through learning from American and European countries＇ good manufacturing practice this paper makes a review on China＇ s good manufacturing practice for medical devices, being established and complemented, to know more about them to some extent.

关 键 词：医疗器械 生产质量 管理规范 监管工作 

分 类 号：R197.39[医药卫生—卫生事业管理]