进口医疗器械产品注册-所需材料
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境外医疗器械首次注册申请材料要求
The following documentation is required for the first registration of medical device manufactured outside of China
（一） 境外医疗器械注册申请表；
Application list of the registration of medical device manufactured outside of China
（二） 医疗器械生产企业资格证明；
Legal Qualification certification for medical device manufacturing enterprise
（三） 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。
Qualification Certification and business license of applicant and Power of Attorney about registration.
（四） 境外政府医疗器械主管部门批准或者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；
Document proving that the government in the country of origin (region) has approved the product to be sold as medical device in the market of that country or region
（五） 适用的产品标准；
Product technical specifications which refer to the requirements for safety and technical functions of the product to be registered and the corresponding testing methods
（六） 医疗器械说明书：
Product instructions for use
（七） 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）;
Type test report (Adapt to Class II and Class III Medical Device)
（八） 医疗器械临床试验资料；
Medical device clinical trials report
（九） 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
（十） 在中国指定售后服务机构的委托书、受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 Undertaking and business license of the authorized agency
（十一）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;
Letter of Authorization for designated agency in China and Letter of Undertaking and business license of the authorized agency
（十二）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