LED灯具北美FCC认证LED发光类产品FDA注册登记解决方案

<p class="MsoNormalCxSpFirst" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">美国食品和药物管理局</span><span lang="EN-US">(Food and Drug Administration)</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">简称</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">，</span><span lang="EN-US">FDA </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">是美国在健康与人类服务部</span><span lang="EN-US"> (DHHS) </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">和公共卫生部</span><span lang="EN-US"> (PHS) </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">中设立的执行机构之一。作为一家科学管理机构，</span><span lang="EN-US">FDA </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">的职责是确保美国本国生产或进口的食品、化妆品、药物、生物制剂、医疗设备和放射产品的安全。它是最早以保护消费者为主要职能的联邦机构之一。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">一、</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">认证流程</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">1.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">提交申请表，样品及相关资料；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">2.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">测试，出具报告；</span><span lang="EN-US">(EN62471+FCC</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">认证</span><span lang="EN-US">)</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">3.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">递交至</span><span lang="EN-US"> FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">审核；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">4.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">审核通过发号，发证。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">2</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">、</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">认证资料准备</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">1</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）产品的名称：提供产品的全称；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">2</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）产品型号：详列所有需要进行实验的产品型号、品种或分类号等；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">3</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）产品预定的用途：例如</span><span lang="EN-US">:</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">家庭、办公室、工厂、煤矿、船舶等；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">4</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）零件表：详列组成产品的零部仵及型号</span><span lang="EN-US">(</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">分类号</span><span lang="EN-US">)</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">、额定值、制造厂家的名称，对于绝缘材料，请提供原材料名称。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">5</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）电性能：对于电子电器类产品，提供电原理图</span><span lang="EN-US">(</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">线路图</span><span lang="EN-US">)</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">、电性能表；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">6</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）结构图：对于大多数产品，需提供产品的结构图或爆炸图、配料表等；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">7</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）产品的照片、使用说明、安全等项或安装说明等。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">二、化妆品</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">注册流程：</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">1</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）客户提供产品资料；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">2</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）业务人员与工程师对产品资料进行；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">3</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）业务给出注册费用和注册周期；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">4</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）客户提供公司资料，产品资料；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">5</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）完成注册。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">&nbsp;</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">三、</span> <span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">食品</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">注册办理流程如下：</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">1</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）咨询</span><span lang="EN-US">---</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">申请人提供产品资料图片或通过描述说明所需要申请</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">的产品；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">2</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）报价</span><span lang="EN-US">---</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">向申请方报价；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">3</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）申请方确认报价后填写测试申请表；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">4</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）工程师根据客户提供的信息在</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">系统上进行注册；</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">5</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）收到</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">确认函</span><span lang="EN-US">+</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">证书（代理方）。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">四、激光产品</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">认证流程：</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">申请激光产品</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">需要提供以下资料：</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">1.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">产品说明书</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">2.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">激光测试报告</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">3.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">激光路径图</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">4.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">生产工厂品质品质流程</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">5.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">整机测试</span><span lang="EN-US">, </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">如耐久性测试</span><span lang="EN-US">, </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">振动测试</span><span lang="EN-US">, </span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">高温高湿测试等，</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">6.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">样品</span><span lang="EN-US">1-2</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">件</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">7.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">激光通路图</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">8.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">标签电子档</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">9.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">品保方面的检测流程图；生产，安装流程图，从来料到入仓的整个过程。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">10.</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">整机测试，如耐久性测试，振动测试，高温高湿测试等。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">五、医疗器械</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">认证，包括：厂家在</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">注册、产品的</span><span lang="EN-US">FDA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">登记、产品上市登记（</span><span lang="EN-US">510</span><span style="font-family: &quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">表登记）、产品上市审核批准（</span><span lang="EN-US">PMA</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family: Tahoma;mso-hansi-font-family:Tahoma">审核）医疗保健器械的标签与技术改造、通关、登记、上市前报告，须提交以下材料：</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">1</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）包装完整的产成品五份</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">2</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）器械构造图及其文字说明</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">3</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）器械的性能及工作原理</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">4</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）器械的安全性论证或试验材料</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">5</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）制造工艺简介</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">6</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）临床试验总结</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;;mso-ascii-font-family:Tahoma;mso-hansi-font-family: Tahoma">（</span><span lang="EN-US">7</span><span style="font-family:&quot;微软雅黑&quot;,&quot;sans-serif&quot;; mso-ascii-font-family:Tahoma;mso-hansi-font-family:Tahoma">）产品说明书，如该器械具有放射性能或释放放射性物质，必须详细描述。</span></p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">&nbsp;</span></p><p style="line-height: 22pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"> </p><p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:auto;mso-margin-bottom-alt: auto;mso-add-space:auto;line-height:20.0pt;mso-line-height-rule:exactly"><span lang="EN-US">&nbsp;</span></p>