<p class="MsoNormal" style="background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><b><span style="font-size:15.0pt;font-family:宋体;mso-ascii-theme-font:
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mso-bidi-font-family:宋体;color:#121212;mso-font-kerning:18.0pt">什么是<span lang="EN-US">FDA</span>认证美国代理人<span lang="EN-US"><o:p></o:p></span></span></b></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><b><span style="font-size:10.5pt;mso-ascii-font-family:
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color:#121212">美国<span lang="EN-US">FDA</span>代理人简介<span lang="EN-US"><o:p></o:p></span></span></b></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">从事制造、制备、传播、配制或加工进口到美国的器械的任何外国机构必须为该机构确定一名美国代理人。<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">有关外国机构美国代理人的信息是使用<span lang="EN-US">FDA</span>统一注册和列表系统（<span lang="EN-US">FURLS</span>系统）以电子方式提交的，并且是机构注册过程的一部分。每个外国机构只能指定一名美国代理人。外国机构也可以但不必指定其美国代理人为其官方代理。国外机构应提供美国代理人的姓，地址，电话和传真号码以及电子邮件地址。<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">确定的美国代理人将需要完成一个自动化流程，以确认他们已同意担任美国代理人。自动化过程会将电子邮件验证请求转发给美国代理人。将要求他们确认她<span lang="EN-US">/</span>他同意代表外国机构担任代表<span lang="EN-US">/</span>联络人。如果美国代理人拒绝同意（或在<span lang="EN-US">10</span>个工作日内未答复），则将通知国外机构的官方通讯员<span lang="EN-US">/</span>所有者运营商，并且必须指定新的美国代理人以履行监管义务。美国<span lang="EN-US">FDA</span>规定，国外的医疗器械、食品、酒类、药品等工厂在进入美国之前必须进行注册，同时必须指定一位美国代理人，该美国代理人负责紧急情况和日常事务交流。美国代理人是指在美国或在美国有商业场所，国外工厂为了进行<span lang="EN-US">FDA</span>注册而指定其为注册代理人。<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><b><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">美国代理商的责任：<span lang="EN-US"><o:p></o:p></span></span></b></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">美国代理商必须居住在美国或在美国设有营业地。美国代理商不能使用邮政信箱作为地址。美国代理商不能仅使用应答服务。他们必须可以接听电话或在正常工作时间内让员工接听电话。<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><b><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">美国代理人职责：<span lang="EN-US"><o:p></o:p></span></span></b></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">美国代理人不能使用邮政局信箱作为地址。美国代理人不能只使用回复服务。他们必须能够接电话，或者在正常工作时间有员工可以接电话。<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><b><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">美国代理人的职责是有限的，包括：<span lang="EN-US"><o:p></o:p></span></span></b></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
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mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">1</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 协助<span lang="EN-US">FDA</span>与国外机构进行沟通；<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
minor-fareast;mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;
mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">2</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;mso-hansi-font-family:
宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 辅助<span lang="EN-US">FDA </span>跟国外企业的沟通；<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
minor-fareast;mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;
mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">3</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 回答有关进口到美国或打算进口到美国的外国机构的设备的问题；<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
minor-fareast;mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;
mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">4</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 就国外企业进口到美国或者提供进口到美国的器械的问题做出回应；<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
minor-fareast;mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;
mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">5</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 协助<span lang="EN-US">FDA</span>安排对国外机构的检查，并协助<span lang="EN-US">FDA</span>安排对外国企业的审查；<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
minor-fareast;mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;
mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">6</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 如果<span lang="EN-US">FDA</span>无法直接或迅速与国外机构联系，则<span lang="EN-US">FDA</span>可能会向美国代理商提供信息或文件，这种行动应被视为等同于向国外机构提供相同的信息或文件；<span lang="EN-US"><o:p></o:p></span></span></p>
<p style="line-height: 20pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><span lang="EN-US" style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:
minor-fareast;mso-fareast-font-family:宋体;mso-fareast-theme-font:minor-fareast;
mso-hansi-font-family:宋体;mso-hansi-theme-font:minor-fareast;color:#121212">7</span><span style="font-size:10.5pt;mso-ascii-font-family:宋体;mso-ascii-theme-font:minor-fareast;
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宋体;mso-hansi-theme-font:minor-fareast;color:#121212">、 若<span lang="EN-US">FDA </span>不能直接或迅速地与外国企业联系，<span lang="EN-US">FDA </span>可以向美国代理人提供信息或文件，此类行为应被等同视为向外国企业提供相同的信息或文件。<span lang="EN-US"><o:p></o:p></span></span></p>
<span style="font-size:10.5pt;font-family:宋体;mso-ascii-theme-font:minor-fareast;
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color:#121212;mso-ansi-language:EN-US;mso-fareast-language:ZH-CN;mso-bidi-language:
AR-SA">请注意， 根据医疗器械报告规定（<span lang="EN-US">21CFR</span>第<span lang="EN-US">803</span>部分），或提交<span lang="EN-US">510</span>（<span lang="EN-US">k</span>）上市前通知（<span lang="EN-US">21CFR</span>第<span lang="EN-US">807</span>部分，<span lang="EN-US">E</span>部分），美国代理商 不承担与不良事件报告相关的</span>
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