进口器械注册资估中英文目录.doc

首次注册 Initial registration 1. 境外医疗器械注册申请表 Application form for registration of import medical device 2. 医疗器械生产企业资格证明 Legal Qualification certification for medical device manufacturing enterprise 3. 申报者的营业执照副本和生产企业授予的代理注册的委托书 A Copy of applicant’s business license and proxy for registration entrusted by the manufacturing enterprise 4. 境外政府医疗器械主管部门批准或认可的该产品作为医疗器械进入该国（地区）市场的证明文件 Documents proving that the product can enter a certain country (or region) as medical device approved or accepted by the medical device competent departments of overseas governments 5. 适用的产品标准（及说明） Applicable product standard and instructions 6. 医疗器械说明书 Specification for medical device 7. 医疗器械检测机构出具的产品注册检测报告（适用于第二类、第三类医疗器械） Test report on product registration given by medical device inspection institutions (applicable to Class II and Class III medical device) 8. 医疗器械临床试验资料 Medical device clinical trials report. 9. 生产企业出具的产品质量保证书 Product Quality Guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin. 10．生产企业在中国指定代理人的委托书、代理人的承诺书及营业执照或者机构登记证明 Proxy of assigned agent of the manufacturer enterprise in china, written commitment of the agent and business license or registration certificate of the agent 11．在中国指定售后服务机构的委托书、被委托机构的承诺书及资格证明文件 Letter of Authorization for designated after-sales service agency in China and Letter of Promise and business license of the authorized agency. 12.所提交材料真实性的自我保证声明 Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted. 原产国不作为医疗器械管理的I类医疗器械还应提交以下资料： Following documents should be provided if Class I medical device in domestic which is not administered by medical device in original country 13.产品全性能监测（自测）报告 Test report on all specifications of the product 14.生产产品的现有资源条件及质量管理能力（含监测手段）的说明 Remarks on the present conditions of the product and the ability in quality control (including insp