今天跟著瀚而普醫(yī)療器械進(jìn)口外貿(mào)代理小編一起去看看醫(yī)療器械進(jìn)口代理的收貨單位應(yīng)具備的資質(zhì)吧。更多醫(yī)療器械進(jìn)口外貿(mào)代理歡迎來(lái)電咨詢(xún)洽談。

1、醫(yī)療器械經(jīng)營(yíng)許可證；

2、營(yíng)業(yè)執(zhí)照(經(jīng)營(yíng)范圍里有銷(xiāo)售醫(yī)療器械許可)；

3、進(jìn)出口權(quán)（若沒(méi)有可以找有資質(zhì)的進(jìn)出口公司代理進(jìn)口）

4、醫(yī)療器械登記表

5、醫(yī)療器械注冊(cè)證

注冊(cè)辦理所需資料

（有效期四年，有效期滿(mǎn)前6個(gè)月應(yīng)申請(qǐng)重新注冊(cè)）

1、境外醫(yī)療器械注冊(cè)申請(qǐng)表

Application form for registration of import medical device

2、醫(yī)療器械生產(chǎn)企業(yè)資格證明

Legal Qualification certification for medical device manufacturing enterprise.

3、申報(bào)者的營(yíng)業(yè)執(zhí)照副本和生產(chǎn)企業(yè)授予的代理注冊(cè)的委托書(shū)

A Copy of applicant’s business license and proxy for registration entrusted by the Manufacturing enterprise

4、境外政府醫(yī)療器械主管部門(mén)批準(zhǔn)或認(rèn)可的該產(chǎn)品作為醫(yī)療器械進(jìn)入該國(guó)（地區(qū)）市場(chǎng)的證明文件

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、適用的產(chǎn)品標(biāo)準(zhǔn)（及說(shuō)明）

Applicable product standard and instructions

6、醫(yī)療器械說(shuō)明書(shū)

Specification for medical device

7、醫(yī)療器械檢測(cè)機(jī)構(gòu)出具的產(chǎn)品注冊(cè)檢測(cè)報(bào)告（適用于第二類(lèi)、第三類(lèi)醫(yī)療器械）

Test report on product registration given by medical device inspection institutions(applicable to Class II and Class III medical device)

8、醫(yī)療器械臨床試驗(yàn)資料

Medical device clinical trials report.

9、生產(chǎn)企業(yè)出具的產(chǎn)品質(zhì)量保證書(shū)

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、生產(chǎn)企業(yè)在中國(guó)指定代理人的委托書(shū)、代理人的承諾書(shū)及營(yíng)業(yè)執(zhí)照或者機(jī)構(gòu)登記證明

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、在中國(guó)指定服務(wù)機(jī)構(gòu)的委托書(shū)、被委托機(jī)構(gòu)的承諾書(shū)及資格證明文件

Letter of Authorization for designated after-sales service agency in China and Letter of Promisa and business license of the authorized agency.

瀚而普外貿(mào)專(zhuān)注醫(yī)療器械進(jìn)口外貿(mào)代理14年,為多家企業(yè)提供醫(yī)療器械進(jìn)口外貿(mào)代理、報(bào)關(guān)、商品編碼歸類(lèi)等一站式醫(yī)療器械進(jìn)口外貿(mào)代理服務(wù).醫(yī)療器械進(jìn)口外貿(mào)代理熱線(xiàn):021-35383360