口罩出口看过来：流程操作及指南，附各国准入需求
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">为全面贯彻关于<span style="color: black;">统一</span>做好新型冠状病毒肺炎疫情防控和经济社会发展工作重要指示精神，落实《海关总署支持外贸企业复工复产10项<span style="color: black;">办法</span>》，结合国内外新冠肺炎疫情防控趋势、国内防护物资产能过剩、外贸企业频繁咨询防护物资出口政策等<span style="color: black;">原因</span>，为促进外贸企业复工复产、有效消化国内富余产能和富余物资，促外贸稳增长，现就防控物资出口通关<span style="color: black;">需求</span>及收集整理的口罩等国外<span style="color: black;">重点</span>技术性贸易<span style="color: black;">办法</span>提示如下。敬请阅读。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">出口通关提示</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">报关前提<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;">收发货人注册编码（慈善<span style="color: black;">公司</span>可为临时编码），需办理无纸化通关法人卡</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">出口资质</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">口罩出口对生产<span style="color: black;">营销</span>单位、境内发货人，除满足国内生产、市场流通资质需求外，中国海关无特殊资质<span style="color: black;">需求</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">出口申报<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.商品归类：</strong>除特殊情况外，绝大部分口罩应归入税号63079000。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">2.检验检疫：</strong>口罩为<span style="color: black;">违法</span>检<span style="color: black;">制品</span>，申报时检验检疫项目无需填报。<span style="color: black;">按照</span>我国政府与<span style="color: black;">关联</span>国家<span style="color: black;">签定</span>的政府间检验协议，对出口伊朗等<span style="color: black;">少许</span>几个国家的<span style="color: black;">制品</span>需按规定进行装运前检验。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">3.关税征免：</strong>如出口物资为贸易性质，征免性质申报<span style="color: black;">通常</span>征税，征免方式申报照章征税；如为捐赠性质，境内发货人为贸易代理商、慈善<span style="color: black;">公司</span>等，征免性质可不填，征免方式申报全免。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">4.禁限管理：</strong><span style="color: black;">日前</span>商务部未对口罩设置贸易<span style="color: black;">管理</span><span style="color: black;">需求</span>，中国海关<span style="color: black;">亦</span>无针对防护物资的监管证件口岸验核<span style="color: black;">需求</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">5.申报规范：</strong><span style="color: black;">根据</span>规范申报<span style="color: black;">需求</span>填写商品名<span style="color: black;">叫作</span>、<span style="color: black;">成份</span>含量；如物资非中国生产，原产国<span style="color: black;">根据</span><span style="color: black;">实质</span>生产国填写。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">出口退税</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">口罩的出口退税率为13%。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">中美关税排除加征</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">美国企业可申请排除口罩进口加征关税，<span style="color: black;">然则</span><span style="color: black;">日前</span><span style="color: black;">仅有</span><span style="color: black;">少许</span>企业获准豁免。详见美国贸易<span style="color: black;">表率</span>办公室网站https://ustr.gov/。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">快速通关<span style="color: black;">保证</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">物资出口申报如遇单窗等系统故障，可联系现场海关采取应急方式处置，<span style="color: black;">或</span>拨打海关12360热线进行咨询。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">↓↓↓以下内容是<span style="color: black;">按照</span>国内外<span style="color: black;">关联</span>↓↓↓</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">政府<span style="color: black;">公司</span>、专业网站、<span style="color: black;">资讯</span><span style="color: black;">报告</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">收集整理而成，仅供参考。<span style="color: black;">详细</span>内容以</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;">关联</span>管理<span style="color: black;">分部</span>、国外官方<span style="color: black;">公司</span><span style="color: black;">需求</span>为准。</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">出口前准备</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;">知道</span>口罩<span style="color: black;">归类</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">国外<span style="color: black;">根据</span>用途<span style="color: black;">通常</span>分为个人防护和医用两类口罩。</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/0424d587255a467fa43dbc40dcfa3628~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=41d4hWNqfuBeDt0JXhEo6XVAVKY%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">国内出口贸易企业需具备的资质和材料</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1．营业执照（经营范围有<span style="color: black;">关联</span>经营内容）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2．企业生产许可证（生产企业）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3．<span style="color: black;">制品</span>检验报告（生产企业）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4．医疗器械注册证（非医用不<span style="color: black;">必须</span>）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5．<span style="color: black;">制品</span>说明书（跟着<span style="color: black;">制品</span><span style="color: black;">供给</span>）、标签（随附<span style="color: black;">制品</span><span style="color: black;">供给</span>）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6．<span style="color: black;">制品</span>批次/号（外包装）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7．<span style="color: black;">制品</span>质量安全书或合格证（跟着<span style="color: black;">制品</span><span style="color: black;">供给</span>）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">8．<span style="color: black;">制品</span>样品<span style="color: black;">照片</span>及外包装<span style="color: black;">照片</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">9．贸易<span style="color: black;">机构</span>须取得海关收发货人注册备案。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">国内出口口罩生产企业资质证明</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产个人防护<span style="color: black;">或</span>工业用非医疗器械管理的普通口罩，有进出口权的企业，可<span style="color: black;">自动</span>直接出口。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产属于医疗器械管理的口罩用于出口，中国海关不<span style="color: black;">必须</span>企业<span style="color: black;">供给</span><span style="color: black;">关联</span>资质证明文件，但<span style="color: black;">通常</span>进口国会<span style="color: black;">需求</span>生产企业<span style="color: black;">供给</span><span style="color: black;">制品</span>三证，以证明该进口的商品在中国已合法上市，<span style="color: black;">详细</span>如下：</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1.营业执照（经营范围<span style="color: black;">包括</span>有医疗器械<span style="color: black;">关联</span>，非医疗级别的物品不<span style="color: black;">必须</span>）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2.医疗器械<span style="color: black;">制品</span>备案证<span style="color: black;">或</span>注册证。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. 厂家检测报告。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">生产企业有进出口权，<span style="color: black;">能够</span><span style="color: black;">自动</span>出口，如<span style="color: black;">无</span>进出口权，<span style="color: black;">能够</span><span style="color: black;">经过</span>外贸代理进行出口<span style="color: black;">营销</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">内贸企业做出口<span style="color: black;">必须</span>取得的基本资质</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 向市场监管<span style="color: black;">分部</span>取得营业执照，<span style="color: black;">增多</span>经营范围“货物进出口、技术进出口、代理进出口”。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. 向商务<span style="color: black;">分部</span>取得进出口权，可直接在商务部业务系统统一平台（</p>http://iecms.mofcom.gov.cn/）申请，网上提交材料。
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. 向外汇管理局申请取得开设外汇账户许可。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4. 办理进出口货物收发货人海关注册登记。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国口罩准入<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;"><span style="color: black;">制品</span>准入<span style="color: black;">要求</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 美国</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">必要资料</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">个人防护口罩</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">必要</span>取得美国 NIOSH检测认证，即National Institute for Occupational Safety and Health美国国家职业安全卫生<span style="color: black;">科研</span>所认证。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">医用口罩</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">须取得美国FDA注册许可。</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/27a6186a422a43a9ac228c32db00d60f~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=hF%2B91sTqbSV%2F%2BIJwJA2%2Ft0Ldgpw%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 欧盟</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">必要资料</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">个人防护口罩</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">个人防护口罩的欧盟标准是EN149，<span style="color: black;">根据</span>标准将口罩分为FFP1/FFP2和FFP3三个类别。所有出口欧盟的口罩<span style="color: black;">必要</span><span style="color: black;">得到</span>CE认证证书。CE认证是欧盟实行的强制性<span style="color: black;">制品</span>安全认证制度，目的是为了<span style="color: black;">保证</span>欧盟国家人民的生命财产安全。</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/76a896a246254b4caa50264e889b729d~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=XQSd4T1r1%2BtWjGpIvuv9EcBFg98%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">医用口罩</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">医用口罩对应的欧盟标准是EN14683。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">制品</span>在欧盟<span style="color: black;">营销</span><span style="color: black;">必须</span>出具欧盟自由<span style="color: black;">营销</span>证书 Free Sale Certificate，有了CE标志并进行了<span style="color: black;">关联</span>指令中<span style="color: black;">需求</span>的欧盟注册后，中国的制造商出口欧盟不<span style="color: black;">必须</span>自由<span style="color: black;">营销</span>证书。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">日本</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">必要资料</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票，日本国外的制造商<span style="color: black;">必要</span>向PMDA注册制造商信息。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">口罩包装<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;">包装上印有ウィルスカット（中文翻译：病毒拦截）99%的字样</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">PFE：0.1um微粒子颗粒过滤效率</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">BFE：细菌过滤率</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">VFE：病毒过滤率</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/87e90f95cfd34f418d6220ed5da4885f~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=wh2VnqFbh7kNrWhZlYXgnkwOV6c%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">口罩品质标准</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 医用防护口罩：符合中国GB 19083-2010 强制性标准，过滤效率≥95%（<span style="color: black;">运用</span>非油性颗粒物测试）。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. N95口罩：美国NIOSH认证，非油性颗粒物过滤效率≥95%。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. KN95口罩：符合中国GB 2626 强制性标准，非油性颗粒物过滤效率≥95%。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 韩国</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">必要资料</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票，韩国进口商营业执照。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">个人防护口罩标准</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">KF (Korean filter) 系列分为KF80、KF94、KF99</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/d7e9453c25e843a5881533c9c5f9fbf3~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=XlXfhWlygDH3wSQcoTjh5jFZ29A%3D" style="width: 50%; margin-bottom: 20px;"></div>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/eeb42b6b9abd4100898c1d3035ffa02b~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=eEgTH40ct4nAZnG0Kt3RoqBqHtM%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">执行标准规范</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">MFDS Notice No. 2015-69</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">韩国医疗器械准入的法规门槛</strong>，基本<span style="color: black;">归类</span>为I、II、III、IV类，持证为韩国<span style="color: black;">机构</span>（License holder），韩国收货人<span style="color: black;">必须</span>到韩国药监局Korea Pharmaceutical Traders Association. 提前备案进口资质（<span style="color: black;">无</span>不行）网址：www.kpta.or.kr。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 澳大利亚</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">必要资料</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">提单，箱单，发票。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">须<span style="color: black;">经过</span>澳洲的<strong style="color: blue;">TGA注册</strong>，符合标准规范：AS/NZS 1716：2012，此规范是澳大利亚和新西兰的<span style="color: black;">呼气</span><span style="color: black;">守护</span><span style="color: black;">安装</span>标准。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">TGA </strong>是Therapeutic Goods Administration的简写，全<span style="color: black;">叫作</span>是治疗商品管理局，它是澳大利亚的治疗商品（<span style="color: black;">包含</span><span style="color: black;">药品</span>、医疗器械、基因科技和血液制品）的监督<span style="color: black;">公司</span>。澳大利亚对医疗器械分为I类，Is and Im， IIa, IIb, III类，<span style="color: black;">制品</span>的<span style="color: black;">归类</span>几乎和欧盟<span style="color: black;">归类</span>一致，<span style="color: black;">倘若</span><span style="color: black;">制品</span><span style="color: black;">已然</span><span style="color: black;">得到</span>CE标志，则<span style="color: black;">制品</span>类别<span style="color: black;">能够</span><span style="color: black;">根据</span>CE<span style="color: black;">归类</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国注册、认证简要办理流程</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">美国NIOSH认证</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">需<span style="color: black;">根据</span>NIOSH的指南实施，企业需寄送样品至NIOSH实验室实施测试，<span style="color: black;">同期</span>提交技术性资料（<span style="color: black;">包含</span>质量体系部分资料）至NIOSH文审，<span style="color: black;">仅有</span>文审和测试都<span style="color: black;">经过</span>，NIOSH才核发批文。NIOSH将其认证的防颗粒物口罩分为9类，<span style="color: black;">详细</span>的测试则由NIOSH下属的NPPTL (National Personal Protective Technology Laboratory)实验室操作。<span style="color: black;">重点</span>测试指标<span style="color: black;">包含</span>呼气阻力测试、呼气阀泄漏测试、吸气阻力测试、过滤效率测试。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 美国FDA注册</strong></p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/dac43b737e574da894c0341ed0a545da~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=CgS2Zw6PRWTtinU86HHT%2FIB8eBQ%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 欧盟CE注册</strong></p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/9e06b44ee9584a328350d674dd8c5206~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=qRtZWk2g9qrGBl%2FmCWbdjPAr3hY%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 日本PMDA注册</strong></p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p26-sign.toutiaoimg.com/pgc-image/22257848949446ecb38d554c6ec009ec~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=kb11%2B8v%2FapgR53E0QZywS0y7ZQ4%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 准备<span style="color: black;">周期</span>。确定<span style="color: black;">制品</span><span style="color: black;">归类</span>（I,II特殊<span style="color: black;">掌控</span>，II类<span style="color: black;">掌控</span>,III,IV）和<span style="color: black;">制品</span>JMDN编码，<span style="color: black;">选取</span>MAH（日本持证方）；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. 制造商向PMDA注册工厂；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. II类特殊<span style="color: black;">掌控</span><span style="color: black;">制品</span>向授权认证<span style="color: black;">公司</span>PCB申请QMS工厂审核，其他II类<span style="color: black;">制品</span>和III类IV类<span style="color: black;">制品</span>向PMDA申请QMS工厂审核，并<span style="color: black;">得到</span>QMS证书；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4. 申请Pre-Market Apporval证书，II类特殊<span style="color: black;">掌控</span>由PCB发证，其他II类<span style="color: black;">制品</span>和III类IV类<span style="color: black;">制品</span><span style="color: black;">掌控</span>由MHLW（厚生劳动省）发证；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5. 支付申请<span style="color: black;">花费</span>；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6. 注册文件整改，注册<span style="color: black;">准许</span>；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7. 所有类别<span style="color: black;">制品</span>均<span style="color: black;">必须</span>MAH向RBHW（厚生省地区<span style="color: black;">公司</span>）进行进口通报注册后<span style="color: black;">才可</span>进口<span style="color: black;">营销</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 韩国KFDA注册</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">韩国卫生福利部（</p>MinistryofHealthandWelfare，MHW），简<span style="color: black;">叫作</span>卫生部，<span style="color: black;">重点</span>负责管食品、<span style="color: black;">药物</span>、<span style="color: black;">打扮</span>品和医疗器械的管理，是最<span style="color: black;">重点</span>的卫生保健<span style="color: black;">分部</span>。<span style="color: black;">按照</span>《医疗器械法》，韩国卫生福利部下属的食品<span style="color: black;">药物</span>安<span style="color: black;">所有</span>负责对医疗器械的监管工作。KFDA注册流程为：
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">1. 确定<span style="color: black;">制品</span><span style="color: black;">归类</span>（I,II,III,IV），<span style="color: black;">选取</span>KLH(韩国持证方)；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">2. II类<span style="color: black;">制品</span>需申请KGMP证书和接受现场审核，II类<span style="color: black;">制品</span>一般是授权的第三方审核员，并<span style="color: black;">得到</span>KGMP证书；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">3. II类<span style="color: black;">制品</span><span style="color: black;">必须</span>送样品到韩国MFDS授权的实验室进行韩国标准的测试；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">4. 由KLH向MFDS（韩国食品<span style="color: black;">药物</span>安<span style="color: black;">所有</span>）提交技术文件（检测报告，KGMP证书等），进行注册审批；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">5. 支付申请<span style="color: black;">花费</span>；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">6. 注册文件整改，注册<span style="color: black;">准许</span>；</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">7. 指定韩国代理商和经销商，产品<span style="color: black;">营销</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"> 澳大利亚TGA注册</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">依据Australian Therapeutic Goods (Medical Devices) Regulations 2002，澳大利亚对医疗器械分为I类，Is and Im， IIa, IIb, III类，<span style="color: black;">制品</span>的<span style="color: black;">归类</span>几乎和欧盟<span style="color: black;">归类</span>一致，<span style="color: black;">倘若</span><span style="color: black;">制品</span><span style="color: black;">已然</span><span style="color: black;">得到</span>CE标志，则<span style="color: black;">制品</span>类别<span style="color: black;">能够</span><span style="color: black;">根据</span>CE<span style="color: black;">归类</span>。<span style="color: black;">倘若</span><span style="color: black;">已然</span><span style="color: black;">得到</span>欧盟公告<span style="color: black;">公司</span>（Notified Body）签发的CE证书，是<span style="color: black;">能够</span>被TGA认可的，并<span style="color: black;">能够</span><span style="color: black;">做为</span>满足澳大利亚安全法规的重要注册资料。</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/7d1cabe0bb114a83ba378b0aa94a1b07~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=kMnqplU66TVgIvJVlU84Ahsl%2Fck%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国口罩技术标准对比</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（供生产企业参考）</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/6d5b1b2c295c447cba22fdd818e7bcb5~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=ljI50k0KQ4njRAdQ6ZPCKqPeMsI%3D" style="width: 50%; margin-bottom: 20px;"></div>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/889704cc62df40b59df664081abe4a80~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=Kc%2Fb03s2XeG1x6Jud%2FtzACPBqo4%3D" style="width: 50%; margin-bottom: 20px;"></div>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/4cec2d8292214842b0da762e3ed37183~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=%2BkpZfSqTvDcpFhA64A8XQbjF7tU%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">各国口罩技术标准</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（供生产企业参考</p>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/dcd16231815f41cfa50f17b299ca2e63~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=LUsvYqB%2Bk2uainoeph6%2BjVnMB6g%3D" style="width: 50%; margin-bottom: 20px;"></div>
<div style="color: black; text-align: left; margin-bottom: 10px;"><img src="https://p3-sign.toutiaoimg.com/pgc-image/6f814e51586a4e71a60b62bd963b9429~noop.image?_iz=58558&from=article.pc_detail&lk3s=953192f4&x-expires=1723305138&x-signature=iV1yDYrGO27t3XAR4MuLfm%2BvGmo%3D" style="width: 50%; margin-bottom: 20px;"></div>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">*以上技术标准如有动态<span style="color: black;">调节</span>，以<span style="color: black;">关联</span>标准管理<span style="color: black;">公司</span>官方发布为准。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">海关将继续发挥技术性贸易<span style="color: black;">办法</span>工作职能，<span style="color: black;">连续</span>关注和收集防护服、消毒用品等其他防疫物资出口国外准入<span style="color: black;">要求</span>和技术标准等技术性贸易<span style="color: black;">办法</span>，<span style="color: black;">即时</span>向外贸企业发布指南，助力企业复工复产，扩大出口。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">如有问题，<span style="color: black;">能够</span>直接联系<span style="color: black;">咱们</span>。</p>
期待楼主的下一次分享！” 我完全赞同你的观点，思考很有深度。 在遇到你之前，我对人世间是否有真正的圣人是怀疑的。 外链发布论坛学习网络优化SEO。 你说得对，我们一起加油，未来可期。
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