DOC《附件2》

1 year before the registration application by a test center recognized by the State Drug Administration. 医疗器械临床试验报告 Medical device clinical trials report. 生产者出具的产品质量保证书,承诺在中国注册销售的产品与在原产国(地区)上市的相同产品的质量完全一致 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. 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营业执照 Letter of Authorization for designated after-sales service agency in China and Letter of Promisa and business license of the authorized agency. 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. 到期重新注册Renewal 申请者的资格证明文件 Qualifications certificate of the applicant. 原注册证复印件 Previous registration certificate. 原产国(地区)政府认可的该产品作为医疗器械进入该国市场的证明文件 Document proving that the government in the country of origin (or region such as the European Community) has approved or recognized the product to be sold as medical device in the market of that country or region. 注册产品标准 Product Standard 产品使用说明书 Product instructions for use. 国家药品监督管理局认可的医疗器械质量检测机构一年内出具的产品检测报告 Test report issued within

1 year before the registration application by a test center recognized by the State Drug Administration. 产品质量跟踪报告 Product quality tracking report. 生产者出具的产品质量保证书,承诺在中国注册销售的产品与在原产国(地区)上市的相同产品的质量完全一致. 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. 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营业执照 Letter of Authorization for designated after-sales service agency in China and Letter of Promises and business license of the authorized agency. 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. 重新注册(增加或变更生产场地) Renewal (Adding or changing production site) 1.原注册证 Privious certificate 2.符合相应产品生产质量体系生产要求的体系考核报告 Production quality system report 3.场地增加或变更情况,及产品无变化的真实性承诺 Explanations of adding or changing production site, and promises of no-changing of product. 其他需要说明的问题Other explanations 申请单位保证书Guaranty of Manufacturer and application Agent 申请单位保证,在本申请表中所申报的内容和所附资料均属实,所附资料中提供的方法和数据均为申报产品所采用的方法和由该产品得到的数据.如查有不实之处,我公司愿负法律责任,承担由此造成的一切后果. We, the applicant, guarantee that all contents declared in this Application Form and all material submitted are true, all methods and data submitted are used in or obtained from this production. If any false data are found, we assume legal responsibility, and hold responsibility for all the serious consequences arising therefore, and accept penalty enforced by People'