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进口医疗器械产品注册-费用
进口医疗器械产品注册-费用
上海：上海维坤商务咨询公司（负责上海及华东客户） (86)21-51087230-183\181
北京：北京迈迪克豪尔医药技术咨询服务有限公司（负责北京及华北客户） (86)10-63323201-8015
在此再三强调，以下任何原创文章的转载需得到维绅公司或北京迈迪克的授权，并注明出处！不得用于任何形式的商业用途！一经发现侵权，本公司将保留运用法律手段维护自身的权利?/p>
以下报价有效期为?008?0??2009???/p>
医疗器械注册代理报价?/span>
Quote of Agent Registration for Medical Device
一?span style="font: 7pt 'Times New Roman'"> 国家审批部门收费?/span>List fee of Approve Department of Nationality
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项目
Item
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?/span>?/span>
Class ?/span>
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?/span>?/span>
Class ?/span>
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?/span>?/span>
Class ?/span>
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办理注册证费
Certification fee
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?/span>3,000
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?/span>3,000
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?/span>3,000
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产品检测费?/span>
Product Examination fee
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?/span>
No
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检测中心根据产品及检测情况收取，约￥15,000~?/span>30,000
According to Examine Center ?/span>15,000~?/span>30,000
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检测中心根据产品及检测情况收取，约￥20,000~?/span>30,000
According to Examine Center ?/span>20,000~?/span>30,000
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临床试验费用
Fee of Clinical Trial
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?/span>
No
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?/span>
No
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按医疗器械临床试验合同收?/span>
According to Contract of Medical Device Clinical Test
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二?/font>代理注册费用 Agent Fee
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项目
Item
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?/span>?/span>
Class ?/span>
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?/span>?/span>
Class ?/span>
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?/span>?/span>
Class ?/span>
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大型设备
Large Model Device
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注册代理费用
Registration agent fee
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?/span>20,000
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?/span>22,000
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?/span>25,000
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?/span>27,000
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拟订产品技术标?/span>
Fee of Writing technical Standard
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?/span>5,000诊断试剂
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非电器类:?/span>6,000
Non-Electric?/span>6,000
电器?/span>:?/span>9,000
Electric?/span>9,000
21-24个月诊断试剂，要临床?/span>4?/span>28新出的规定，不得少于200，不得少?/span>3个批次?/span>
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非电器类:?/span>6,000
Non-Electric?/span>6,000电器?/span>: ?/span>9,000
Electric?/span>9,000
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电器?/span>: ?/span>10,000
Electric?/span>10,000
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代理检测费?/span>
Fee of Examination Agent
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?/span>
No
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?/span>6,000
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?/span>6,000
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?/span>6,000
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代理临床试验费用
Fee of Clinical Trial
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?/span>
No
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6-50?/span>
No
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?/span>100,000?/span>Implant Medical Device?/span>
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?/span>
No
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备注?/span>1、以上价格为一个产品的收费标准，一个产品一个型号，每增加一个型号增收注册代理费?/span>10%?/span>
2、仅委托拟订产品技术标准或代理检测，每增加一个型号增收相应费用的10%?/span>
Remarks: 1?/span>The price above is according to the charging standard of one product, and one product corresponds to
one type. 10% of the corresponding fee per type will be charged.
2?/span>If only consigning to write technical standard or take charge for examination , 10% of the corresponding
fee per type will be charged.
三?/font>资料翻译?/span>Fee of Translation
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项目
ITEM
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英译?/span>
ENGLISH TO CHINESE
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其它小语?/span>
OTHER LANGUAGE
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费用（元/千字?/span>
Fee (RMB/Per thousand words)
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?/span>160
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实报实销
According to the actual instance
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相关链接
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