资料分享|埃及医疗器械法规及要求CAPA N.001 中英对照
Medical Device Regulatory
Requirements for
Egypt
Introduction to the Egypt Regulatory System
The Ministry of Health and Population (MOHP), is the key government agency charged with meeting Egypt's healthcare needs and regulations. MOHP is the organization that manages and coordinates standardization activities in Egypt. There is little local medicalequipment production so the market relies mainly on imports and is extremely receptive to American medical products because of the advanced technology and associated training, well-developed marketing systems, as well as financing available through U.S. AID's Commodity Import Program. FDA approval is key to having medical products registered, although the Ministry of Health may still do additional testing on any medical device.
埃及医疗器械法规要求埃及医疗法规体系简介
MOHP人口卫生部,作为政府重要机构,负责埃及医疗健康事业和法规的制定。并且负责管理和协调标准化工作。当地的医疗器械生产企业很少,所以市场需求主要依靠进口,并且很乐于进口美洲等国的产品,基于他们先进的技术和相关的技术培训,成熟的营销体系。并适时由美国国际商品援助计划进行资助。虽然卫生部会做进一步的医疗器械测试,但FDA的产品注册登记才是关键。
标准由埃及标准化与质量控制组织颁布,适用于某些特殊的医疗诊断仪器和设备。对于没有现存强制标准的其他医疗产品,等同采用国际标准:国际标准ISO、欧洲标准EN(在缺少欧洲标准的情况下,英标、德标、法标也可以采用)、美国标准、日本标准。在缺少埃及标准或国际标准的情况下,主管当局需参考产品随机检测报告。
埃及是禁进口翻新使用的医疗设备,该禁止不存在区分对待--基于影像设备或其他基础设备计算机的复杂程度。目前,任何新医疗设备在批准进口至埃及前,需要检查其原产地销售证明和安全证明,进口商需要递交进口申请至卫生部,用于医疗器械设备的批准,进口商附上原产国官方卫生机构出具的证书,注明此医疗设备的进口概述,及安全使用声明。
******************************************************
Medical Device Regulatory Requirements for Egypt 1 中英对照.zip
暂无评论