进口医疗器械注册证办理所需资料
境外医疗器械注册申请表
Applicationform for registration of import medical device
医疗器械生产企业资格证明
Legal certification for medical device manufacturingenterprise.
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 ofapplicant’s business license and proxy for registration entrustedby the
Manufacturingenterprise
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
Documentsproving that the product can enter a certain country (or region) asmedical
Deviceapproved or accepted by the medical device competent departments ofoverseas governments
适用的产品标准（及说明）
Applicableproduct standard and instructions
医疗器械说明书
Specificationfor medical device
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）
Testreport on product registration given by medical device inspectioninstitutions(applicable to Class II and Class III medicaldevice)
医疗器械临床试验资料
Medicaldevice clinical trials report.
生产企业出具的产品质量合格书
Product Guarantee issued by the manufacturer certifying that the of the product to be registered for sale in China isexactly the same as that of the product marketed in the country(region) of origin.
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 ofassigned agent of the manufacturer enterprise in china, writtenCommitment of the agent and business license or registrationcertificate of the agent
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 ofAuthorization for designated after-sales service agency in Chinaand Letter of Promisa and business license of the authorizedagency.
****（有效期四年，有效期满前6个月应申请重新注册）
