注册申请应附资料及顺序
List of Documents Attached
注：请在对应项目右侧方框内划√。如根据有关规定，某项材料不需提交，请在该项目右侧的方框内划#，并在本表“其它需要说明的问题”栏中写明理由。
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┃ 首次注册 ┃
┃ Initial registration ┃
┠───────────────────────────────────────┬──┨
┃1 生产者的合法生产资格的证明文件 │ □┃
┃Legal Qualification certification for medical device manufacturing enterprise.│ ┃
┃ │ ┃
┃2 申请者的资格证明文件 │ ┃
┃Qualification Certification of applicant. │ □┃
┃ │ ┃
┃3 原产国（地区）政府批准或认可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 regions such│ ┃
┃as Taiwan, Hong Kong or Macao) has approved or recognized the product to be │ ┃
┃sold as medical device in the market of that country or region. │ ┃
┃4 注册产品标准 │ ┃
┃product standard │ □┃
┃5 产品使用说明书 │ ┃
┃Product instructions for use. │ ┃
┃6 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. │ ┃
┃7 医疗器械临床试验报告 │ □┃
┃Medical device clinical trials report. │ ┃
┃8 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. │ ┃
┃9 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. │ ┃
┃10 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 ┃
┠────────────────────────────────────────┬─┨
┃1 申请者的资格证明文件 │□┃
┃Qualifications certificate of the applicant. │ ┃
┃2 原注册证复印件 │ ┃
┃Previous registration certificate. │□┃
┃3 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. │ ┃
┃4 注册产品标准 │ ┃
┃Product Standard │ ┃
┃5 产品使用说明书 │□┃
┃Product instructions for use. │ ┃
┃6 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. │ ┃
┃7 产品质量跟踪报告 │□┃
┃Product quality tracking report. │ ┃
┃8 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. │ ┃
┃9 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. │ ┃
┃10 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. │ ┃
┃ │□┃
┃ │ ┃
┃ │□┃
┃ │ ┃
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