今天跟着瀚而普医疗器械进口外贸代理小编一起去看看医疗器械进口代理的收货单位应具备的资质吧。更多医疗器械进口外贸代理欢迎来电咨询洽谈。

1、医疗器械经营许可证；

2、营业执照(经营范围里有销售医疗器械许可)；

3、进出口权（若没有可以找有资质的进出口公司代理进口）

4、医疗器械登记表

5、医疗器械注册证

注册办理所需资料

（有效期四年，有效期满前6个月应申请重新注册）

1、境外医疗器械注册申请表

Application form for registration of import medical device

2、医疗器械生产企业资格证明

Legal Qualification certification for medical device manufacturing enterprise.

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、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

5、适用的产品标准（及说明）

Applicable product standard and instructions

6、医疗器械说明书

Specification for medical device

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.

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.

瀚而普外贸专注医疗器械进口外贸代理14年,为多家企业提供医疗器械进口外贸代理、报关、商品编码归类等一站式医疗器械进口外贸代理服务.医疗器械进口外贸代理热线:021-35383360