我公司主要经营保税仓储，进出口代理，医疗器械第三方服务商

进口医疗器械注册证办理所需资料

1、境外医疗器械注册申请表

Application form for registration of import medical device 

2、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 

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、医疗器械生产企业资格证明

Legal Qualification certification for medical device manufacturing enterprise. 

5、医疗器械说明书

Specification for medical device 

6、适用的产品标准（及说明）

Applicable product standard and instructions 

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**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 Promisa and business license of the authorized agency.

四、进口医疗器械免税条件及办理程序

1、医疗器械进口免税条件

非营利性医疗、科研、教学单位用于身体的康复、科研、教学的进口仪器设备，符合免税条件的可免征进口关税。

2、进口医疗器械免税申请流程

【1】先到项目主管部门申领《国家鼓励发展的内外资项目确认书》，凭确认书到海关办理减免税手续。

【2】减免税项目海关备案审批流程办理：

1、海关进行三级审批。 
       2、申请单位填写《征免税证明申请表》，并到预录中心预录；
      3、申请单位持所需单证及预录表提交海关备案初审；
      4、 申请单位提供减免税备案所需单证文件；