倒计时！速卖通强制美国打扮品FDA合规，卖家尽快行动
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_gif/r5enZ37iaBoFycxnn0h5l17G4CiabDyKfg3Ydn6Mtlxzia6K5XC3Uyuavo8Jo51iaYXNvhKrXGwDFrNaicy2X6udJvg/640?wx_fmt=gif&tp=webp&wxfrom=5&wx_lazy=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">在美国有<span style="color: black;">营销</span>或计划<span style="color: black;">营销</span><span style="color: black;">打扮</span>品的卖家们<span style="color: black;">重视</span>了！</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">近期</span>，</span><strong style="color: blue;"><span style="color: black;">速卖通发布加强<span style="color: black;">打扮</span>品美国资质管控的公告</span></strong><span style="color: black;">，<span style="color: black;">需求</span><span style="color: black;">营销</span>至美国地区的<span style="color: black;">打扮</span>品类卖家，需完成FDA注册和<span style="color: black;">制品</span>列明。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">平台将于2024年7月1日起对未合规商品进行屏蔽。</span></strong></span><span style="color: black;">请商家尽快完成<span style="color: black;">打扮</span>品类商品的合规<span style="color: black;">需求</span>和发布类目的规范<span style="color: black;">需求</span>，以<span style="color: black;">保证</span>对美贸易的平顺。</span></p><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoEK0OIqRSrL3U4XTrEnXcz9yvubeicKoUNKlTTDpMV9YuMzGia1Sianh8OFiatsQqe9gkxOM8jgzxYxTA/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">FDA商品管控范围</strong></span></p><strong style="color: blue;"><span style="color: black;"><span style="color: black;">打扮</span>品<span style="color: black;">一般</span>指</span></strong><span style="color: black;"><span style="color: black;">经过</span>揉擦、倾倒、喷洒或喷洒在人体或其任何部位，或以其他方式将其引入人体或其任何部位，用于清洁、美化、<span style="color: black;">增多</span>吸引力或改变外观的物品；以及拟用作任何此类物品部件的物品。</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">FDA将<span style="color: black;">打扮</span>品分为下列17大类</span></strong></span><span style="color: black;">，若属于下列范围的商品均属于平台管控范围：</span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoEK0OIqRSrL3U4XTrEnXcz9fsDAB9qf5pgsFaic7pMrwHDgUcsPsYngYibicibeNicDNgxyM9t60feGBBg/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">除此之外，<span style="color: black;"><strong style="color: blue;">还有既是<span style="color: black;">打扮</span>品又是OTC<span style="color: black;">药物</span>的商品在管控范围之内</strong></span>。<span style="color: black;">按照</span>美国法律，许多个人护理<span style="color: black;">制品</span>均<span style="color: black;">做为</span>OTC<span style="color: black;">药物</span>进行监管，例如声<span style="color: black;">叫作</span><span style="color: black;">拥有</span>以下特性的<span style="color: black;">制品</span>：</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（1）防晒</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（2）预防和治疗头皮屑和痤疮</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（3）头发修复和生长</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（4）皮肤漂白和美白</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（5）皮肤和嘴唇<span style="color: black;">守护</span>剂</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（6）胶原蛋白生产</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（7）免疫和循环系统改善</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（8）皮肤<span style="color: black;">损害</span>愈合</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">FDA的合规<span style="color: black;">需求</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">1</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">普通<span style="color: black;">打扮</span>品的合规<span style="color: black;">需求</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">资质<span style="color: black;">需求</span>：</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（1）美国FDA企业<span style="color: black;">设备</span>注册+<span style="color: black;">制品</span>列名证明材料</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（2）<span style="color: black;">倘若</span>是符合FD&C Act规定可豁免FDA注册的小型企业，则应<span style="color: black;">供给</span>签字盖章的小型企业豁免承诺函（特殊品类不可豁免）</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/sYmzWsM9mVMrpt34hNw4eAqcmcvDzUGuR7icLzHsejGgBuM6apiazyK8bSYmCo2ZGibtfnvviaVGWDsDvzp2ZjDVsg/640?wx_fmt=jpeg&from=appmsg&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">US标签<span style="color: black;">需求</span>：</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1）<span style="color: black;">成份</span>表</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2）身份声明</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3）制造商、包装商或分销商的名<span style="color: black;">叫作</span>和营业地点</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4）净含量声明</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5）原产国：如Made in China</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6）不良事件报告联系方式：美国<span style="color: black;">位置</span>、美国<span style="color: black;">tel</span>号码或电子联系信息或网站</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7）芳香过敏原</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">8）专业<span style="color: black;">打扮</span>品（如适用）：标签还必须清楚<span style="color: black;">明显</span>地<span style="color: black;">显示</span>该<span style="color: black;">制品</span>仅由<span style="color: black;">得到</span>许可的专业人士管理或<span style="color: black;">运用</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">2</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">既是<span style="color: black;">打扮</span>品又是OTC<span style="color: black;">药物</span>的合规<span style="color: black;">需求</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">资质<span style="color: black;">需求</span>：</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">美国FDA<span style="color: black;">药物</span>企业<span style="color: black;">设备</span>注册+<span style="color: black;">制品</span>注册（<span style="color: black;">得到</span>National Drug Code，即NDC号）+生产企业GMP证书</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">US标签<span style="color: black;">需求</span>：</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1）<span style="color: black;">药物</span>信息</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2）活性<span style="color: black;">成份</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3）目的</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4）用途</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5）警告声明</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6）说明</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7）其他信息</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">8）活性<span style="color: black;">成份</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">9）问题</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">3</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">其他<span style="color: black;">需求</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">1、专业<span style="color: black;">打扮</span>品必须符合现有的<span style="color: black;">打扮</span>品标签<span style="color: black;">需求</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">专业<span style="color: black;">打扮</span>品的标签必须清楚、<span style="color: black;">明显</span>地<span style="color: black;">显示</span>该<span style="color: black;">制品</span>仅由<span style="color: black;">得到</span>许可的专业人士管理或<span style="color: black;">运用</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">2、<span style="color: black;">打扮</span>品<span style="color: black;">不可</span>进行虚假宣传管控</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">虚假宣传范围<span style="color: black;">包含</span>但不限于下列情形：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（1）申报为<span style="color: black;">打扮</span>品的商品明示<span style="color: black;">或</span>暗示<span style="color: black;">拥有</span>医疗或<span style="color: black;">拥有</span><span style="color: black;">必定</span>功效<span style="color: black;">功效</span>的内容；（2）虚假<span style="color: black;">或</span>引人误解的内容；（3）违反社会公序良俗的内容；（4）法律、行政法规禁止标注的其他内容。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">3、<span style="color: black;">打扮</span>品<span style="color: black;">不该</span>含禁售<span style="color: black;">成份</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">打扮</span>品禁售<span style="color: black;">成份</span>管控参考美国FDA<span style="color: black;">关联</span><span style="color: black;">需求</span>：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">Prohibited&RestrictedIngredientsinCosmetics</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">重视</span>事项：可豁免/不可豁免商品都需要提交商品标签实拍图，<span style="color: black;"><strong style="color: blue;">US商品标签必须含有美代信息<span style="color: black;">才可</span>审核<span style="color: black;">经过</span></strong></span>，若<span style="color: black;">日前</span>店铺还<span style="color: black;">无</span>申请美代，<span style="color: black;">能够</span>咨询跨境卖家参谋办理。</p><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoEK0OIqRSrL3U4XTrEnXcz9Zpvc2cQvJUETK14Ws7uYr8DDjmj9u0Gt1TrcicM357k9NndbGNKmFWw/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;">
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">怎样</span>完成FDA资质认证</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">为了更好的<span style="color: black;">帮忙</span>商家完成合规义务，降低经营成本，<strong style="color: blue;">速卖通平台特联合甄选了行业中<span style="color: black;">优秀</span>的服务商</strong>，<span style="color: black;">一起</span>推出平台专属<span style="color: black;">补助</span>福利，<span style="color: black;">帮忙</span>卖家<span style="color: black;">容易</span>搞定美国市场。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">做为</span>速卖通官方认证的金牌服务商之一，跨境卖家参谋能以专业<span style="color: black;">有效</span>的服务<span style="color: black;">帮忙</span>卖家完成FDA合规</span></strong></span><span style="color: black;">，</span><span style="color: black;">点击下方链接一键办理：</span><a style="color: black;">点此直达</a></p><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoGt3sLWwQvWBiaoGRDgYoWNyOx7HzVZTkXC4qJdZsj4GjVAaqtrgAVdu6XRsDoX3ecrOr4nAlZ3kQQ/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoGt3sLWwQvWBiaoGRDgYoWNyOXDD9nJYBEY310WoicxObwnQVAibAlqqgJicvXvopIRFaG5nsqvzIKBgQ/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/r5enZ37iaBoGt3sLWwQvWBiaoGRDgYoWNyctHQ1AmTXIeby334CopAyK4WVxzDBEuyrGA7CHxG0ib1r92UpmI2PYA/640?wx_fmt=jpeg&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">● </span></strong></span></strong></span><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">怎样</span>判断商品叶子类目<span style="color: black;">是不是</span>需要做普通<span style="color: black;">打扮</span>品资质认证？</span></strong></span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">资质上传页面仅展示了「美国<span style="color: black;">打扮</span>品FDA备案证明」和「外包装/标签实拍图」，即<span style="color: black;">表率</span>该<span style="color: black;">制品</span>需要做普通<span style="color: black;">打扮</span>品资质认证（如图所示）</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoEK0OIqRSrL3U4XTrEnXcz9Tl56oibzDURYTaF8UKAcmCDbquBuh8ZfSVOicib1LQyYicCPcXVndJOvtw/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">● </span></strong></span></strong><span style="color: black;">怎样</span>判断商品叶子类目<span style="color: black;">是不是</span>需要做OTC资质</span></strong></span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">认证？</span></strong></span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">资质上传入口需要上传「生产企业GMP证书」、「美国<span style="color: black;">打扮</span>品FDA备案证明」和「外包装/标签实拍图」，即<span style="color: black;">表率</span>该<span style="color: black;">制品</span>需要做OTC资质认证（如图所示）</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_png/r5enZ37iaBoEK0OIqRSrL3U4XTrEnXcz9Spqve9TEmwUsQKHxjoNHWjpoJX7GrNNTU4H51F7iaya25kibfem7mq2g/640?wx_fmt=png&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">怎样</span>上传FDA资质</strong></span></p><span style="color: black;">登录商家后台，进入「商品」-「商品管理」页面 - <span style="color: black;">选取</span>相应的<span style="color: black;">制品</span></span><span style="color: black;">点击【编辑】商品 -「美国资质」-</span><span style="color: black;">上传「美国<span style="color: black;">打扮</span>品FDA备案证明」</span><span style="color: black;">-</span><span style="color: black;">上传「外包装/标签实拍图」</span><span style="color: black;">- 操作「提交」</span><span style="color: black;">提交成功后，平台会进行审核</span><span style="color: black;">（注: 审核时间<span style="color: black;">通常</span>为T+2个工作日）</span><strong style="color: blue;"><span style="color: black;">温馨提示：</span></strong><span style="color: black;">若需要上传多张资质证明，请将资质证明图整合到一个word或Pdf中，再打包上传文件哦！</span>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/r5enZ37iaBoGt3sLWwQvWBiaoGRDgYoWNyfT9icPRY2Ka2tzCxjLApjOPy17ZKBsYkXaB0Aiam8ZkKB8cOFn2FV32w/640?wx_fmt=other&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/r5enZ37iaBoGt3sLWwQvWBiaoGRDgYoWNyicq0vCVxUh0dd5kiaibBgGD7wxryULGKnNpLU6b9YTfjPpLZgte0jvFBA/640?wx_fmt=other&from=appmsg&tp=webp&wxfrom=5&wx_lazy=1&wx_co=1" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">5</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">其他<span style="color: black;">平常</span>问题</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">Q</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">MoCRA法规范畴下<span style="color: black;">打扮</span>品FDA企业注册中有责任人和代理人两个角色，这两个角色的责任分别是什么？</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">A</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">责任人（Responsible Person）：</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">是将<span style="color: black;">制品</span>引入市场的实体。<span style="color: black;">她们</span>的任务是<span style="color: black;">保证</span><span style="color: black;">打扮</span>品符合相应的法规和标准，是<span style="color: black;">制品</span>列名提交和更新的主体。Responsible person本身不需要是美国<span style="color: black;">机构</span>，<span style="color: black;">亦</span><span style="color: black;">能够</span>是中国商家或美国买家。</p><strong style="color: blue;">美国代理人（US Agent）：</strong>代理人必须<span style="color: black;">位置于</span>美国境内，并在美国设有营业地点且真实运营的。非美国企业在递交企业注册时必须指定一个美国代理人负责与FDA沟通，<span style="color: black;">她们</span><span style="color: black;">能够</span>全天候为不良事件报告、调查问询、紧急通信等<span style="color: black;">供给</span>服务，是FDA与企业的沟通桥梁。跨境卖家参谋可办理。
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">Q</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">经营<span style="color: black;">打扮</span>品的贸易商<span style="color: black;">是不是</span>需要做FDA注册？</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">A</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">贸易商不需要做<span style="color: black;">打扮</span>品FDA企业注册，但<span style="color: black;">倘若</span>贸易商为品牌商，出口的品牌商品销往美国，则需要做<span style="color: black;">打扮</span>品FDA商品注册列名。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">Q</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">同类<span style="color: black;">打扮</span>品商品<span style="color: black;">是不是</span>可做一个FDA商品列名注册？</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">A</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">多个颜色或<span style="color: black;">区别</span>香味，<span style="color: black;">区别</span>容量的商品可做一个FDA商品注册列名，<span style="color: black;">详细</span>参考法规。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">Q</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">商家既不是<span style="color: black;">打扮</span>品品牌方，<span style="color: black;">亦</span>不是生产商，<span style="color: black;">是不是</span>不需要做FDA注册及商品列名？这种<span style="color: black;">状况</span>下商家在速卖通<span style="color: black;">营销</span>需要满足什么<span style="color: black;">要求</span>？</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">A</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">这种<span style="color: black;">状况</span>下商家不需要做FDA企业注册和FDA商品列名注册，但需要其合作的生产企业做FDA企业注册，<span style="color: black;">同期</span>提醒其进口的品牌方做FDA商品列名。<strong style="color: blue;">商家需要满足<span style="color: black;">打扮</span>品贸易型企业<span style="color: black;">需求</span>的资质。</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">美国FDA<span style="color: black;">打扮</span>品管控--商家<span style="color: black;">平常</span>问题答疑：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">https://www.yuque.com/wanghuan-53jp2/bny9fi/eatvzuz9rco<span style="color: black;">公斤</span>d7g?singleDoc#</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">美国FDA资质审核合规指引：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">https://www.yuque.com/wanghuan-53jp2/bny9fi/vbyzh4e1gdomzvob#l6XIR</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">详细</span>法规可参考： </strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">https://www.fda.gov/cosmetics/cosmetics-exporters/cosmetics-export-certificate-faqs#Is_my_product</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">OTC专论介绍：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">https://dps.fda.gov/omuf/monographsearch</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://mmbiz.qpic.cn/mmbiz_jpg/r5enZ37iaBoEN5Eu7oAknaJwkkq9T4AP7AXOh7kiaXy8XmgCXnzSianXibwxkpv4qPWNJl5U0Dh55NXDKQrAEianm3g/640?wx_fmt=other&from=appmsg&wxfrom=5&wx_lazy=1&wx_co=1&tp=webp" style="width: 50%; margin-bottom: 20px;"></p><span style="color: black;">总之，</span><span style="color: black;"><strong style="color: blue;"><span style="color: black;">关联</span>买家需要在2024年7月1日前完成FDA注册及<span style="color: black;">制品</span>列名</strong></span><span style="color: black;">，FDA</span><span style="color: black;">合规工作迫在眉睫，尽快联系跨境卖家参谋完成合规</span><span style="color: black;">。</span><strong style="color: blue;"><span style="color: black;"><span style="color: black;">做为</span>亚马逊、速卖通、TEMU等官方<span style="color: black;">举荐</span>的SPN金牌服务商</span></strong><span style="color: black;">，跨境卖家参谋<span style="color: black;">持有</span>专业的税务专家与资深合规团队，为您的出海之路保驾护航。</span><span style="color: black;"><span style="color: black;">供给</span>管家式离岸<span style="color: black;">机构</span>注册、财税VAT、环保EPR、合规认证、知识产权及海外工商服务等，累计服务中国跨境商家100000+。</span>
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