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<section data-role="paragraph" data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><p><span>来源：12360海关热线 国际货运交易平台 medworld器械世界</span></p><p><br /></p><p><span>商务部海关总署国家药品监督管理局公告2020年第5号关于有序开展医疗物资出口的公告（生效日期：2020年4月1日，涉及范围：5类，具体为：新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计）</span></p><p><br /></p><p><span>海关总署公告2020年第53号医疗物资实施出口商品检验（生效日期：2020年4月10日，涉及范围：11类医疗物资，具体为：医用口罩,医用防护服,红外测温仪,呼吸机,医用手术帽,医用护目镜,医用手套,医用鞋套,病员监护仪,医用消毒巾,医用消毒剂）</span></p><p><br /></p><section data-color="rgb(239, 112, 96)"><section><section><section><section>说明：以下防疫物资出口问题的问答基础是：出口企业有进出口经营权，且营业执照有相关经营许可（比如货物进出口、技术进出口、代理进出口等），向外汇管理局取得开设外汇账户许可，并在海关办理注册登记。</section></section></section></section></section><section><p><br /></p></section><section><span><strong>防疫物资出口问答100题</strong></span></section><section><br /></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section data-brushtype="text"><strong>1、目前海关对医疗物资出口查验情况如何？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>目前海关通过加强对单证的审核和现场的查验力度来保证医疗物资的有序出口，具体包括：</p><p>1、对医疗物资的出口实施100%的单证审核，包括对企业提交的发票、清单、医疗器械产品注册证书、企业符合质量标准声明等进行全面审核，审核发现并查扣一批质量不符合要求的出口医疗物资；</p><p>2、加强对医疗物资出口的查验力度，通过对货物的内外包装、颜色外观、生产日期、保质期、合格证的审核等设置查验重点，防止三无和污染变质等不合格的医疗物蒙混过关；</p><p>3、加强对出口医疗物资品牌的审核，防止侵犯知识产权等次生风险的产生；</p><p>4、加强对FDA、CE等认证证书的审核，确保证书的准确和与产品的声明标准符合；</p><section>5、通过总署官网和各直属海关APP、中国报关协会等行业组织的在线平台，加强线上线下对企业的宣传和辅导，有效的保障企业及时了解最新的出口医疗物资的最新政策和操作指南，保障了出口医疗物资的高效通关。</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>2、海关总署53号公告的11类医疗物资出口法检，具体怎么办理？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>对53号公告所列11类出口法检医疗物资企业通过单一窗口申报报关，不同于其他出口法检商品的是，此次新增法检出口医疗物资无需实施产地检验，报关时无需出口电子底账。</section><section>（1）对出口法检医疗物资，企业需在报关单商品名称栏填报用途，并注明是否医用，检测试剂需注明是否为新型冠状病毒检测用。</section><section>温馨提示：同一HS编码下既有医疗物资又有非医疗物资的，应根据商品本身特征即生产制造标准，确定是否医用。</section><section>（2）对三部委“5号公告”所列（含公告后续调整所列）的出口新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计5类医疗物资，企业向海关报关时，须提供书面或电子声明和我国医疗器械产品注册证书。新冠病毒检测试剂还须提供药监部门出具的出口销售证明。</section><section>（3）对其他出口法检医疗物资，企业向海关报关时，应当提供医疗器械产品注册/备案证明和质量安全承诺声明。对无相关证明和承诺声明的，海关将实施严密监管。</section><section>（4）对新冠病毒检测试剂，发货人应当申请卫生检疫审批，凭《入/出境特殊物品卫生检疫审批单》通过单一窗口报检，经海关检验合格后，获得电子底账，报关时填写电子底账帐号。</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section>Q</section></section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>3、如3.31公告后，5号公告的目录及国家药监更新的目录链接内的注册信息很少，那不在目录内，但是省级和国家药监局网站能查到的资质，这类物资能不能正常申报出口?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>公告的目录在动态更新，如果国家药监局网站可以查到相关企业的注册信息，此类物资可以正常出口。 </p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>4、药监局官网如何查询有效的产品注册信息，有发现5号公告附表中的生产厂家查不到。可提供网址吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>如需查询请登录国家药监局官网(www.nmpa.gov.cn/WS04/CL2582/)，如5号公告附件2中没有，以药监局官网更新为准。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>5、求各位公布一下:鉴别、假冒、伪劣防疫物资的经验</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>比如查验过程中有发现三无产品（无生产厂家，无执行标准，无有效日期），这些是明显不合格的防疫物资，不得出口。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>6、如果产品上，有CE、FDA、NIOSH字样的产品，是认定为医用的？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>认证标志并不是判定医用的唯一依据，主要是从包装上的品名（MEDECAL,SURGICAL为医用），以及执行标准来判断。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section>Q</section></section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>7、对中国来说是非医用的个人防护口罩，是否出口欧盟还是要办理CE证，反而非无菌类医用口罩，进入欧盟只需要自我申明即可？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>个人防护口罩不属于医疗器械，但需符合欧盟个人防护设备条例EU2016/425(PPE)要求，由授权公告机构进行CE认证并颁发证书，对应的标准是EN149。按照标准将口罩分为FFP1/FFP2和FFP3三个类别.非无菌类医用口罩在欧盟医疗器械分类中属于低风险医疗器械，进入欧盟只需要企业进行符合性声明，完成产品的技术文档和产品注册，相关符合性评估由企业自行负责执行。</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>8、KJ3出口医用物资，也是按5号公告要求来吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>是的。5号公告的要求目前没有区分贸易性质，一般贸易、捐赠物资、其他进出口免费均需提供。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>9、5号公告要求提交的证书应该是由出口贸易公司提交生产厂家申请的证书？因为二类医疗器械，贸易公司无需注册许可，好像只要备案就行了，对吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>5号公告明确自4月1日起，出口新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计的企业向海关报关时，须提供书面或电子声明，承诺出口产品已取得我国医疗器械产品注册证书，符合进口国（地区）的质量标准要求。海关凭药品监督管理部门批准的医疗器械产品注册证书验放。这个医疗器械注册证书是指生产企业的《医疗器械产品注册证书》。目前海关对于贸易公司无特殊企业资质要求。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>10、关于贸易代理公司代理出口医疗物资或是一、二、三类医疗器械，海关不需要验核贸易公司的任何医疗的经营范围、经营资质、经营许可?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>贸易代理公司需要有进出口经营权和相关货物进出口经营范围，不需要医疗器械资质许可。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>11、非医用的任何地方不能有医用的标志，有的话不行，没有的话重新按照非医用包装为什么不行？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>企业应如实申报，外包装须和货物实际属性相符。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>12、口罩的检测标准是什么？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>口罩分为医用/非医用两种，医用口罩分为：医用防护、医用外科、一次性医用；非医用口罩也被称为个人防护口罩，分为防颗粒物和日常防护口罩两种。</p><p>国内口罩类检测标准如下：</p><p>医用防护口罩：GB 19083-2010</p><p>医用外科口罩：YY 0469-2011</p><p>医用一次性口罩：YY/T 0969-2013</p><p>工业防颗粒物口罩（例如KN95口罩）：GB 2626-2006</p><p>日常防护口罩：GB/T 32610-2016</p><section>普通口罩：FZ/T 73049-2014</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>13、第一类医疗器械的备案是算民用吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>第一类医疗器械，属于医用</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>14、出口贸易企业的经营范围有要求没？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>目前，海关对于贸易企业无经营范围的要求。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>15、怎么区分医用和非医用？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>从产品包装和执行标准来判断是医用还是非医用。</section><p>以口罩为例：</p><p>1、从外观和包装信息区分：带过滤阀的口罩一般不会是医用口罩。外包装上带有“医用”或英文“surgical"'Medical"的，可判断是医用口罩。</p><p>2、通过适用标准区分：医用口罩在不同国家/地区适用不同标准和认证要求，可根据产品进口国家/地区及产品的适用标准进行区分，产品适用标准和认证信息可从产品外包装或生产提供的检测报告或证书获得。</p><p>中、美、欧三个国家/地区医用口罩标准：KN/N/CE</p><p>3、通过政府注册管控信息进行区分</p><p><br /></p><section>中国：</section><section>通过医疗器械准入号查询，链接为：</section><section>http://www.nmpa.gov.cn/WS04/CL2590/</section><section><br /></section><section>美国：</section><section>已获得美国FDA准入的口罩产品可以通过其官网查询注册证书号进行查询，链接为：</section><section>https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm</section><section>另外根据FDA最新政策，目前是在满足一定条件的情况下认可中国标准的口罩，其授权企业的链接为：</section><section>https://www.fda.gov/media/136663/download</section><section><br /></section><section>欧盟：</section><section>出口欧盟医用口罩可通过获得授权的公告机构进行查询，其中欧盟医疗器械指令93/42/EEC（MDD）授权的公告机构查询地址为：</section><section>https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13</section><section>欧盟医疗器械条例EU 2017/745（MDR）授权的公告机构查询地址为：</section><section>https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34</section><p>海关总署商检司将不定期更新部分国家或地区防疫物资技术法规和标准，目前已更新至第三版:</p><p>http://sjs.customs.gov.cn/sjs/zcfg56/2951967/index.html</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>16、我们是生产汽车零部件的企业，有进出口权，可以直接出口防疫物资吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>1、确认公司经营范围是否有相关经营许可（（比如货物进出口、技术进出口、代理进出口）。</p><section>2、若是自己生产，涉及5号公告的5类物资及53号公告医疗物资需要具备医疗器械资质。若是从其他厂家采购，则需要从具有医疗器械资质的生产厂家采购</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>17、内贸转外贸怎么理解呢？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>内贸转外贸是指经营国内贸易的公司转做对外贸易，需要具备的基础条件为：</p><p>1、向市场监管部门取得营业执照，增加经营范围“货物进出口、技术进出口、代理进出口” ；</p><p>2、向商务部门取得进出口权；</p><p>3、向外汇管理局取得开设外汇账户许可；</p><section>4、办理进出口货物收发货人海关注册登记。</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>18、一般进出口有限公司营业范围没有医疗设备或产品的话？可以出口一次性医用口罩吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>可以。从具有医疗器械经营资质的医药销售公司采购，或从具有出口医疗器械资质的生产厂家采购，则可以出口。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>19、口罩机属于医疗器械么？民用口罩出口不用受医疗器械出口资质的限制吧？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>口罩机不属于医疗器械。非医用口罩不属于医疗器械，不用受医疗器械出口资质的限制，但需要满足进口国相关准入要求。比如欧盟的CE证明或认可证书、个人防护口罩须取得美国NIOSH检测注册、医用口罩须取得美国FDA注册许可、日本需要向PMDA注册等。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>20、包装上印有医疗/medical等字样是否就要在报关时提交国内注册资质?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>是的</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>21、任何一家有进出口权的企业都可以出口有国内正规资质的企业的口罩对吧？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>非医用口罩，可以正常出口。如果是医用口罩，生产厂家需要提供医疗器械注册证。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>22、请问生产许可证是必须的吗？因为我们营业执照范围有，工厂没有生产许可证,可以吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>如果是非医用物资，工厂无需医疗器械资质。如果是5号公告下的5类医疗物资出口（新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计)，及53号公告所列医疗物资，工厂必须具备医疗器械资质。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>23、外贸代理公司代理国内贸易公司出口，要审核贸易公司的医疗器械经营资格吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>如果是代理国内贸易公司出口，不需要审核国内贸易公司的医疗器械经营资格。如果是从国内贸易公司购买，则需要从具有医疗器械经营资质的医药销售公司采购，或从具有出口医疗器械资质的生产厂家采购，则可以出口。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>24、如果厂家有相关注册证书和经营证书，而贸易公司没有这些证书，那么是任何贸易公司都可以出口医用和非医用的以及三类医疗物资产品吗？医疗物品不管是自用还是医用，毕竟属于卫生物资，应该具备至少经营许可吧，因为食品类的贸易进出口企业按原则就需要取得经营许可，而且仓库也要符合相关规定标准，但是海关好像不太要求。或者说行业规定与海关规定的尺度和规则是否不同呢?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>是的，如果厂家有相关资质，有进出口经营权的贸易公司可以出口。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>25、贸易公司出口医用口罩，除了需要工厂提供医疗器械注册证以外，贸易公司本身是否也需要提供医疗器械注册证?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>贸易公司不需要医疗器械相关资质。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>26、贸易公司采购或验货时，需要关注生产厂家的资质和资料有哪些？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>1、企业生产许可证</p><p>2、产品检验报告</p><p>3、医疗器械注册证或备案证（非医用不需要）</p><p>4、产品说明书（跟着产品提供）、标签（随附产品提供）</p><p>5、产品批次/号（外包装）</p><p>6、产品质量安全书或合格证（跟着产品提供，按最小包装）</p><p>7、产品样品图片及外包装图片</p><section>8、国外准入的证书或其他证明材料（比如CE证书等）</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>27、 贸易公司有进出口权，准备购买口罩出口，生产企业有医疗器械注册证，且符合国外质量标准，贸易公司需要准备什么资料？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>医用口罩需要发货人做出出口医疗物资合格声明，并提交生产厂家的医疗器械注册证。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>28、国内使用YY/T 0969-2003标准CE证书使用的是149:2001+A1：2009 是否可以认为是防护口罩？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>YY是医药行业标准，是医用口罩，对应CE标准应为EN14683，所以这张显示EN149的CE证书是无效的。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>29、营业执照里的内容指什么?关于医疗器械出口，还是没有搞明白，一类，二类，三类出口的时候外贸公司分别需要提供哪些资料？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>是指营业执照有相关经营许可（比如货物进出口、技术进出口、代理进出口等）。</p><p><br /></p><p>医疗器械出口除正常需要提供的合同发票箱单等资料外，其他随附单据要求：属于5号公告涉及的医疗防控物资必须随附出口质量声明、医疗器械产品注册证书（必须在有效期内），生产企业必须在国家药监局网站名单内。（注意：53号公告的11类医疗物资也需要提供，以免影响通关）</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>30、麻烦问下护目镜在国内有企业有药监局的备案证书吗？出口企业是否必有这类资质证书吧？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>5号公告未对护目镜有医疗器械资质的要求，但4/10公布的海关总署53号公告，医用护目镜需要办理出口法检。（不需要办理电子底账，但需要同5号公告提供相医疗器械产品注册证书和出口质量声明，以免影响通关）</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>31、如果生产许可证上的范围是第一类医疗器械的话，这个工厂生产的产品算个人防护产品还是医用？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>根据《医疗器械监督管理条例》第五条规定：国际对医疗器械实现分类管理。第一类是指，通过常规管理足以保证其安全性，有效性的医疗器械。具有一类医疗器械许可证的企业，并不是说生产的产品就一定是医用产品，具体要看生产产品其执行的标准和具体产品所在药监局的注册备案信息。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>32、新冠病毒核算检测试剂盒是几类医疗器械？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>新冠病毒试剂盒这种与致病性病原体抗原、抗体以及核酸等检测相关的试剂，按国家法规，属于体外诊断试剂的第三类。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>33、我司是有进出口权的贸易公司从厂家采购了一批医用外科口罩，经实验室检测也确实符合医用外科标准YY 0469-2011，但厂家只有药监局的医疗器械生产备案凭证，没有商务部5号公告要求的医疗器械注册证，我司能以厂家备案凭证出口吗？（另外，医用口罩本属于二类注册管理，不知道为什么药监局给的却是一类备案凭证，如果能凭备案出口，类别这里是否会存在问题）</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>按照5号公告，医用口罩出口须取得我国医疗器械产品注册证书，及提供出口医疗物资声明，及符合进口国（地区）的质量标准要求，且生产企业须在药监局公布的企业名单之内。否则不可以出口。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>34、国内NGO捐赠的物资是否要通过国内红会统一捐出？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>没有这方面的强制要求。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>35、<br />1）外贸易公司接订单，如果出口非医用的口罩和防护服，需要提供什么材料？如果需要提供材料这些材料是生产工厂提供？<br />2）个人防护口罩和防护服是不是就是非医用标准？<br />3）出口到美国的非医用的口罩和防护服需要做NOISH认证吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>1) 非医用的按照普通货物提供资料即可。</section><section>2）按照非医用标准生产的口罩和防护服属于个人防护类物资。</section><p>3）个人防护口罩出口美国须取得美国NIOSH检测注册。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>36、因为国内外医用标准不同，尤其口罩，能否专门汇总一下问题。现在国内批复了一部分防疫物资的一次性医用口罩（国内标准YY/T0969-2013）生产厂家，这部分厂家都是备案证书，能否按照防护（非医用）口罩出口?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>国内出口：企业应如实申报，国内标准YY/T0969-2013是医用口罩，按照医用口罩的要求来申报。</p><section>海外进口：须符合进口国/地区要求，取得进口国相关认证许可。</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>37、非医用的需要提供什么材料吗?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>按照普通货物，商品编码对应的监管条件申报出口，但需要取得进口国相关认证许可。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>38、报关品名的问题：品牌+规格+一次性医用口罩？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>是的。口罩、防护服的出口申报按如何申报要求，在报关单商品名称栏详细填报品牌，规格型号和用途，商品实际属性达到医用标准的必须填报“医用”，口罩按照“个”填报申报数量，其他医疗物资出口申报以及报关单其他栏位的填报，严格遵守《中华人民共和国海关进出口货物报关单填制规范》（海关总署2019年第18号公告）要求。</section><p>（在确定是否医疗物资时，根据商品实际属性而非使用用途，也就是即使个人使用的医用口罩，也是申报“医用”。）</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>39、是不是英文打了MEDICAL就按照医用来要求？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>目前国内批复的很多防疫物资有的就是医用外科的备案，因为外包装上有标准啊。但是这部分备案生产的企业，目前都没有注册证书，也就是说都不能出口？</p><p>外包装打了MEDICAL，执行标准是医用就是医用物资，外包装和执行标准保持一致，以免因未如实申报造成处罚。</p><section>医用的厂家必须具备医疗器械注册证。</section></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>40、民用口罩出口应该注意什么？民用口罩出口申报注意事项？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>民用口罩出口对生产销售单位、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要求。申报规范：按照规范申报要求填写，申报时体现“非医用”。另外须符合进口国的规定和要求。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>41、防护服出口需要提供哪些资料?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>首先区分防护服是否医用，非医用按照正常通关要求进行，医用防护服出口需要按照5号公告及海关总署53号公告的出口法检要求，同时取得进口国相关认证许可。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>42、咨询一下：防疫医疗包能整体出吗？（里面包含了口罩、消毒液、创口贴、碘伏棉棒、药盒、消毒湿巾、一次性手套、一次性鞋套、护目镜、体温计）</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>不符合归类总规则五零售成套包装的定义，建议分别归类并申报。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>43、企业提供符合性声明，是什么声明？是5号公告中的声明吗？但5号公告不是只对医用的才需要吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>按照5号公告，自4月1日起，出口新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计的企业向海关报关时，须提供书面或电子声明（模版见公告附件1），承诺出口产品已取得我国医疗器械产品注册证书（相关注册信息见附件2），符合进口国（地区）的质量标准要求。</p><section>非医用防疫物资海关无特殊要求。</section></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>44、民用出欧盟，要不要中国公司出符合性声明?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>非医用不需要。</section><section><br /></section><section>此外目前进入欧盟的非医用个人防护口罩属于第III类防护重度风险，需要提供CE证书。</section></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>45、如果我们出口防护物资给客户，用于工厂员工自己防护，算医用吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>根据商品实际属性确定医用还是非医用，不是按使用用途。也就是即使个人使用的医用口罩，也是申报“医用”。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>46、贸易公司出口，是否只要生产企业资质齐全，并符合进口国要求，贸易公司是否可以单抬头报关出口退税？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>贸易公司自营出口，可以单抬头申报，委托出口报关单上需要体现生产消费单位,具体以当地海关要求为准。</section><section><br /></section><section>但均需按照海关相关要求提供相应资质文件。</section></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>47、贸易公司想出口医用口罩，但是营业执照上没有相关资质。但采购的工厂有资质，有三证。这样贸易公司可以出口么？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>贸易公司营业执照须具备经营许可（比如货物进出口、技术进出口、代理进出口等），不需要医疗器械经营资质。</p></section></section></section></section></section></section></section></section></section><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section>Q</section></section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>48、请问普通口罩的外包装上如有99%抗菌(BEF99% PFE99% VFE99%)的字样但使用标准是GB/T32610-2016非医用标准，是不是仍然不属于医用口罩,可以按普通民用口罩出口？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>可以，GB/T32610-2016是非医用口罩。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>49、出口销售证明及出口备案，是否只有进口国要求了才申请？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>医疗物资出口按5号公告提供出口相关资质和海关总署53号公告进行出口法检，以及按进口国的要求在进口国通关时提供。</p></section></section></section></section></section></section></section></section><section data-role="paragraph" data-color="rgb(63,"><section data-role="outer" label="Powered by gulangu"><section data-tools="gulangu" data-id="93831" data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>50、国内注册的基金会向国外捐助医疗物资，必须通过红十字会吗？不通过红十字会的话如何操作呢？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>对外捐助可以不通过慈善机构，可以申报其他进出口免费，但相关要求不变。</section><section><br /></section><section>由于近期政策变化较快，以上问题解答仅供参考，请以当地海关现场要求为准。</section><section><br /></section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section data-brushtype="text"><strong>51、酒精出口是否要申请出口许可证？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>根据产品成分含量等确定商品编码及对应监管条件申报出口。酒精浓度80%及以上的未改性乙醇，其税号22071000涉及G证即《两用物项和技术出口许可证（定向）》监管，出口企业须向商务部授权发证机关申请并取得两用物项和技术向特定国家（地区）出口时签发的许可证件。以2207100000 酒精浓度在80%及以上的未改性乙醇为例，申报要素：</section><section>0:品牌类型;</section><section>1:出口享惠情况;</section><section>2:品名[中文及外文名称];</section><section>3:加工方法[未改性、改性];</section><section>4:酒精浓度;</section><section>5:品牌[中文及外文名称];</section><section>6:GTIN;</section><section>7:CAS; </section><section>8:监管条件：ABG</section><section>9:检验建议类别：M.R/N.S</section><p><br /></p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section data-brushtype="text"><strong>52、现在民用一次性平面口罩出口，内盒和外箱上，是否要印刷工厂的厂名，地址，电话，然后附上合格证，说明书，这样才行，否则就算是三无产品？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>是的。均应是合格产品。</section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>53、之前中国防疫紧张时期进口到国内的医疗器械现在能出口到国外吗？比如呼吸机（有医疗器械进口注册证），出口时国内海关有哪些要求？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>建议按退运方式处理。</section></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>54、商检是生产企业还是贸易企业要办商检？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>出口法检的货物，可以由生产厂家或者外贸公司在生产厂家所在地海关报检，办理电子底账。(提醒：对53号公告所列11类出口法检医疗物资企业通过单一窗口申报报关，不同于其他出口法检商品的是，此次新增法检出口医疗物资无需实施产地检验，报关时无需出口电子底账。）具体要求详见<a target="_blank" href="http://mp.weixin.qq.com/s?__biz=MjM5Nzk0MDA0MQ==&mid=2649986216&idx=2&sn=ccfd40e50caac0ad9223f82e7772cf47&chksm=bed56a8e89a2e398884ba3c5416bb806f239839de6b372883f8994efd234382d35bd38721d2d&token=1916696004&lang=zh_CN&scene=21#wechat_redirect" textvalue="100问（上）" tab="innerlink" data-linktype="2">100问（上）</a>第2条解答。</section><section><br /></section><section>法律依据：按照《进出口商品检验法》和《进出口商品检验法实施条例》第二十四条 法定检验的出口商品的发货人应当在海关总署统一规定的地点和期限内，持合同等必要的凭证和相关批准文件向出入境检验检疫机构报检。法定检验的出口商品未经检验或者经检验不合格的，不准出口。</section><section><br /></section><section>出口商品应当在商品的生产地检验。海关总署可以根据便利对外贸易和进出口商品检验工作的需要，指定在其他地点检验。</section><section><br /></section><section>出口实行验证管理的商品，发货人应当向出入境检验检疫机构申请验证。出入境检验检疫机构按照海关总署的规定实施验证。</section></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>55、民用防护口罩，非医用，是否需要法检？ </strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>不需要。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>56、如何查询企业是否有报检资质？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>登录中国国际贸易单一窗口标准版,http://singlewindow.cn/,标准版应用中，选择“企业资质”，可办理注册及查询。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>57、如果公司只有一类医疗产品备案，并没有注册证，是否可以出口，我的个人理解是只有二类三类才需要医疗器械注册证？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>可以，一类医疗器械实施的备案，并非注册。因此只有备案证，没有注册证。</p><p><br /></p><p>按照医疗器械监督管理条例第八条，第一类医疗器械实行产品备案管理，第二类、第三类医疗器械实行产品注册管理。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>58、我们出口美国口罩需要哪些证书?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>个人防护口罩须取得美国NIOSH检测注册，医用口罩须取得美国FDA注册许可。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>59、检测试剂篇中出口通关要求的申请卫生检疫审批和出口法检货物申报，有什么区别？谢谢？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>是两个环节，卫生检疫审批是试剂类法检货物申报的前提条件。检测试剂出口需先申请卫生检疫审批，获得后再在单一窗口办理出口检验检疫。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>60、现在很多在华外企需要在国内采购口罩，来捐赠给同一集团的国外企业，1.监管方式能用捐赠物资吗？2.如果可以用捐赠物资的名义还需要企业办理经营范围变更吗?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>此种情况监管方式应为“其他进出口免费”，海关对经营范围无特殊要求。经营范围要求，建议咨询当地市场监督局。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>61、报关单上的生产销售单位必须要打工厂吗？可以直接打贸易公司吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>按照《中华人民共和国海关进出口货物报关单填制规范》生产销售单位填报出口货物在境内的生产或销售单位的名称，包括：</p><p><br /></p><p>1．自行出口货物的单位。</p><p>2．委托进出口企业出口货物的单位。</p><p>3．免税品经营单位经营出口退税国产商品的，填报该免税品经营单位统一管理的免税店。</p><p><br /></p><p>以医疗物资出口来讲，以下视不同情形：</p><p><br /></p><p>如果贸易公司从工厂购进货物并出口，为自营出口，贸易公司收汇并退税，生产销售单位打贸易公司。</p><p><br /></p><p>如果是工厂委托贸易公司出口，为代理出口，贸易公司收汇，工厂办理退税，生产销售单位打工厂。</p><p><br /></p><p>具体以当地海关要求为准。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>62、请问所有的额温枪都属于医疗物资吗？还是一样分医用、非医用？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>根据《医疗器械分类目录》，额温枪属于体温测量设备，管理类别为第二类医疗器械。根据《医疗器械经营监督管理办法》，第二类、第三类医疗器械实行注册管理，需要办理《医疗器械注册证》。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>63、我想问一下，在出口一次性非医用口罩到日本的时候，JHPIA所要求的必须提供吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>目前日本对于非医用口罩的标准是：</p><p><br /></p><p>JIS T 8151：2018《防尘口罩》</p><p><br /></p><p>日本卫生材料工业联合会 JHPIA:《口罩展示和宣传的自愿标准》</p><p><br /></p><p>日本卫生材料工业联合会 JHPIA:《口罩卫生安全—卫生自愿标准》</p><p><br /></p><p>出口一次性非医用口罩到日本由于是自愿标准，不是必须提供。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>64、海关对如口罩产品的外包装及包装箱有何具体要求？例如不认可大的纸箱，需要小包装，而且不能是中性包装。可否细化下海关对包装的要求？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>包装须符合出口包装检验检疫要求。</p><p><br /></p><p>以下几点口罩出口包装注意事项，供参考，具体以口岸海关要求为准。</p><p><br /></p><p>1，民用（非医用）不出现FDA字样，FDA是医用的，海关严查，企业应如实申报。</p><p>2，合格证上信息齐全（产品名称、型号规格、生产批次、生产日期、保质日期、技术标准、材质、生产厂家等）</p><p>3，包装勿以简陋的散装，最小包装以可以零售包装为标准，采取规范的彩袋或规范的纸盒。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>65、熔喷无纺布是否被管控不允许出口，或者说有条件出口？如果有限制出口的，要怎样才能出口？如果确实禁止的，外贸企业也好提早打消签订合同的计划？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><section>目前没有特别出口管制。</section></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>66、比如做了500万个口罩的商检，N个客户出的数量不同，都可以用这份商检吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>目前，对于口罩类产品，报关无需办理电子底账，但依据海关总署2020年53号公告，医用口罩须进行出口商品检验。</p><p><br /></p><p>此外，一批法检货物可以办理多个电子底账号，但出口法检货物一票出口报关单对应一份电子底账数据号。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>67、外贸公司出口医疗器械2类产品，如医用口罩，需要外贸公司去办理2类医疗器械经销备案，还是2类医疗器械经销许可证？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>海关对外贸企业经营范围无特殊要求。</p><p><br /></p><p>经营范围要求，建议咨询当地市场监督局。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>68、国内销售的产品需要做商检吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>在国内销售，须符合国内产品标准。</p><p><br /></p><section>以口罩为例，国内口罩类检测标准如下：</section><section>医用防护口罩：GB 19083-2010</section><section>医用外科口罩：YY 0469-2011</section><section>医用一次性口罩：YY/T 0969-2013</section><section>工业防颗粒物口罩（例如KN95口罩）：GB 2626-2006</section><section>日常防护口罩：GB/T 32610-2016</section><p>普通口罩：FZ/T 73049-2014</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>69、原先国内疫情期间办理了进口应急注册备案的企业，现在能否以应急注册备案说明出口到国外？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>关于“应急注册备案”各省份要求不同，以福建为例，有效期3个月，详见福建药品监督管理局2020年2月5出台《服务企业保障防护医疗器械产品供应特别措施》http://yjj.scjgj.fujian.gov.cn/zwgk/xwdt/sjdt/202002/t20200205_5190219.htm。</p><p><br /></p><p>广东省药品监督管理局关于印发《广东省防控新型冠状病毒感染的肺炎疫情所需药品医疗 器械行政许可应急审批程序》的通知http://mpa.gd.gov.cn/zwgk/gzwj/content/post_2882230.html</p><p><br /></p><p>具体以各区域药监局要求为准。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>70、口罩出口到加拿大，原来了解到的认证要求是与美国标准是一样的，但是现在好像没有认证要求，请问海关是否知悉最新情况？可直接出口？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>加拿大医疗器械产品分为4类，其中一类风险最低，不需要做MDL（器械注册），只需要做MDEL（制造商注册）。口罩产品在加拿大作为一类医疗器械产品进行管控。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>71、国内生产制造型企业，经营范围没有民用口罩（劳保用品），因国外客人需要，民用口罩是否可以和，自己企业生产的货物拼装一个集装箱出口给国外客人？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>民用口罩出口报关时商品名称栏填报用途，注明非医用，按普通货物出口申报。现阶段口罩类商品属于海关严查商品，条件允许的情况下建议分开发运，避免影响其他货物的通关或海外清关。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>72、捐赠类：基金会捐赠，国外接收方必须是红十字会或其他政府机构吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>国外NGO是否也可以作为接收方？捐赠的话，产品质量的证明和声明，需要生产厂家做还是基金会做？</p><p><br /></p><p>捐赠的国外接收方可以是社会团队，也可以是个人。</p><p><br /></p><p>5号公告和53号公告目前没有区分贸易性质，一般贸易、捐赠物资、其他进出口免费，属于公告范围的医疗物资均须提供医疗器械产品注册/备案证明和质量安全承诺声明，可从具有医疗器械经营资质的医疗物资销售公司采购，或从具有医疗器械生产资质的厂家采购。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>73、因为我们曾经注册过贸易公司经营进口保健品，海关好像对经营资质不太有要求，但是我们是比较谨慎的公司，经询问行业主管部门，需要申请批复经营许可证，而且对仓库也有规则规定。所以想问一下，医用的、非医用的产品、卫生、防护产品毕竟属于与人体相关的卫生安全的产品，如果贸易公司在存储、运输、经营方面不懂得任何产品相关的规定、注意事项，有可能会造成相关问题。听到海关对贸易公司的经营方面有考量，想问问是否有具体的相关规定及标准，明确指出海关有不需要经营许可的规定？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>可以参考：中华人民共和国国务院令第680号《医疗器械监督管理条例》http://www.gov.cn/gongbao/content/2017/content_5197006.htm</p><p>《进口医疗器械检验监督管理办法》http://www.gov.cn/flfg/2007-06/29/content_666402.htm</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>74、请问，我们是外贸公司，只有二类医疗器械经营许可，但工厂有三类医疗器械许可证,我们想出口三类医疗器械，请问我们能否做出口代理呢？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>目前海关对外贸公司无经营资质要求，可以做代理出口。</p><p><br /></p><p>经营范围要求，建议咨询当地市场监督局。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>75、医疗器械厂家生产的第三类产品，只能卖给有第三类经营许可证的医疗机构或经销商吗?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>根据《医疗器械监督管理条例》医疗器械生产企业应进行医疗器械生产备案或注册，从事第二类第三类医疗器械的经营企业，应具备相关经营许可资质，医疗器械经营企业、使用单位购进医疗器械，应当建立进货查验记录制度。</p><p><br /></p><p>1，《医疗器械监督管理条例》第二十一条，从事第一类医疗器械生产的，由生产企业向所在地设区的市级人民政府食品药品监督管理部门备案并提交其符合本条例第二十条规定条件的证明资料。第二十二条，从事第二类、第三类医疗器械生产的，生产企业应当向所在地省、自治区、直辖市人民政府食品药品监督管理部门申请生产许可并提交其符合本条例第二十条规定条件的证明资料以及所生产医疗器械的注册证。 </p><p><br /></p><p>2，第三十条，从事第二类医疗器械经营的，由经营企业向所在地设区的市级人民政府食品药品监督管理部门备案并提交其符合本条例第二十九条规定条件的证明资料。</p><p><br /></p><p>第三十一条，从事第三类医疗器械经营的，经营企业应当向所在地设区的市级人民政府食品药品监督管理部门申请经营许可并提交其符合本条例第二十九条规定条件的证明资料。 </p><p><br /></p><p>3，第三十二条规定 医疗器械经营企业、使用单位购进医疗器械，应当查验供货者的资质和医疗器械的合格证明文件，建立进货查验记录制度。从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业，还应当建立销售记录制度。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>76、护目镜非医用第一类、第二类请问这个分类怎么界定？出口企业报关时自己判断吗?</strong></section></section><section><section data-autoskip="1"><p><br /></p><p>详见国家药品监督管理局关于发布医疗器械分类目录的公告（2017年第104号）http://www.nmpa.gov.cn/WS04/CL2138/300389.html及相关通告和公告。</p><p><br /></p><p>请通过“国家药品监督管理局”（www.nmpa.gov.cn）的官网进行产品信息确认。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>77、 对于N95口罩出口英国，如何判断认证是否规范？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>N95是美国国家职业安全卫生研究所认证的9种颗粒物防护口罩中的一种,不是英国认证标准.</p><p><br /></p><p>国标KN90：过滤效率90%；</p><p>国标KN95：过滤效率95%；</p><p>国标KN100：过滤效率99.97%。</p><p><br /></p><p>美标N90：过滤效率90%；</p><p>美标N95：过滤效率95%。</p><p><br /></p><p>欧标FFP1：过滤效率≥80%；</p><p>欧标FFP2：过滤效率≥94%；</p><p>欧标FFP3：过滤效率≥99%。</p><p><br /></p><p>国标和美标的过滤效率只针对非油性颗粒物、欧标油性颗粒物和非油性都包括。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>78、报援助，出口非欧盟国家，CE不需要了吧？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>对于出口申报，5号公告和53号公告目前没有区分贸易性质，一般贸易、捐赠物资、其他进出口免费，医疗物资须提供相关资质文件。</p><p><br /></p><p>对于海外进口，须符合对应进口国（地区）的质量标准要求，不同国家（地区）标准不同。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>79、出口非无菌的医用口罩到欧盟，CE要求比个人防护还低啊，只需要声明？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>首先医用口罩对应的欧盟标准是EN14683，个人防护设备标准是EN 149。医用口罩在欧盟的医疗器械中属于低风险医疗器械，个人防护口罩在欧盟的个人防护产品中属于高风险产品；个人防护口罩需要欧盟公告机构出具ce证书。</p><p><br /></p><p>非无菌医用口罩：企业只需进行CE自我符合性声明，不需要通过公告机构认证。在准备好相应文件及测试报告等资料后，即可自行完成符合性声明。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>80、我们出口一次性医用口罩6000个，外包装无ce字样，可以出口吗，比利时能进口非无菌口罩?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>CE是欧盟认证标志，医用口罩没有CE标志，不能出口，请办理认证之后再出口。</p><p><br /></p><p>比利时进口无菌口罩，见Q79。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>81、隔离衣和防护服可以归到一个HS下面吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><p>不能仅从品名判断，需要根据两者的实际商品属性确定商品编码，若商品属性相同，可以归入同一商品编码，若不同则分别归类。</p><p><br /></p><p>除特殊情况外，绝大部分防护服根据材质应归入如下税号：化学纤维62101030，橡胶40159010，塑料39262090。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>82、隔离衣有没有分医用非医用？医用是要什么检测标准？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>隔离衣是个广义的概念。我国的防护服分级标准为中华人民共和国医药行业标准YY/T 1499-2016《医用防护服的液体阻隔性能和分级》，其将医疗防护服一共分为了4级，等级越高，防护性能越好。</p><p><br /></p><p>医用防护服属于二类医疗器械，需要接受二类医疗器械的相关标准审查，根据要求进行生产。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>83、请问非医用护目镜出口印度清关需要什么证书吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>非医用护目镜不需要相关证书。</p><p><br /></p><p>医用护目镜印度的标准为：IS 5983-1980《眼睛保护器 》Eye-protectors</p><p><br /></p><p>详见：部分国家（地区）防疫物资技术法规和标准要求（第三版）http://sjs.customs.gov.cn/sjs/zcfg56/2951967/index.html</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>84、民用一次性口罩，非医用，需要有食品药品监督管理局的资质才可以出吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>不需要。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>85、请问一下民用物资和医用物质外箱打印的唛头有什么要求吗？一定印刷的还是可以贴的？生产商和收货方信息都要有吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>海关加强对医疗物资出口的查验力度，通过对货物的内外包装、颜色外观、生产日期、保质期、合格证的审核等设置查验重点，防止三无和污染变质等不合格的医疗物资蒙混过关。</p><p><br /></p><p>对包装的要求，请参考Q64。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>86、请教一个问题，口罩的BFE是医用标准，PFE是民用标准，那这个口罩归医用还是民用？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>从产品包装和执行标准来判断是医用还是非医用。</p><p><br /></p><p>以医用外科口罩为例，行业标准YY 0469-2011《医用外科口罩技术要求》中相关规定，其中关于过滤的标准：</p><p><br /></p><p>细菌过滤效率（BFE）：口罩的细菌过滤效率应不小于95%。?</p><p><br /></p><p>颗粒过滤效率（PFE）：口罩对非油性颗粒的过滤效率应不小于30%。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>87、熔喷布的生产和检测标准是什么?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>目前我国专门针对熔喷布有推荐标准</p><p><br /></p><p>FZ/T 64034-2014 《纺粘/熔喷/纺粘(SMS)法非织造布》</p><p><br /></p><p>GB/T 30923-2014 《塑料 聚丙烯(PP)熔喷专用料》</p><p><br /></p><p>但一般熔喷布检测参照GB 2626-2006《呼吸防护用品——自吸过滤式防颗粒物呼吸器》进行检测（现行有效），该标准的更新版本GB 2626-2019将于2020年7月1日实施。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>88、现在民用口罩不用商检对吧？医用口罩商检流程是怎样的呢？工厂和外贸公司各要做哪些事情？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>民用口罩出口对生产销售单位、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要求。申报规范：按照规范申报要求填写，申报时体现“非医用”。</p><p><br /></p><p>医用口罩按照53号公告，不同于其他出口法检商品的是，53号公告新增法检出口医疗物资无需实施产地检验，报关时无需出口电子底账。企业需在报关单商品名称栏填报用途，注明医用。向海关报关时，应当提供医疗器械产品注册/备案证明和质量安全承诺声明。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>89、如果只有一个海关编码，民用、医用都是这个HS No.63079000，是否都要法检？而且国外欧美普通民众是不戴口罩的，要戴一定要戴FDA/CE认证的. 这个请帮忙解释一下？</strong></section></section><section><section data-autoskip="1"><p><br /></p><p>医疗物资出口，须同时满足中国标准要求及海外进口国（地区）标准要求。</p><p><br /></p><p>民用、医用口罩国内出口要求参考Q88。</p><p><br /></p><p>进口国（地区）标准，具体每个国家（地区）标准不同。</p><p><br /></p><p>比如欧盟的CE证明或认可证书、个人防护口罩须取得美国NIOSH检测注册，医用口罩须取得美国FDA注册许可、日本需要向PMDA注册等。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>90、咨询大家一下，KN95 防护口罩检测是不是只做呼吸阻力，和过滤效率这两项？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>工业防颗粒物口罩（例如KN95口罩）：技术标准GB 2626-2006，请查询具体标准了解。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>91、现在药品出口捐赠是什么政策？比如莲花清瘟?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>药品进入其他国家，需在当地以药品身份注册获得上市许可，请先确认该药品是否已在该国家（地区）获得上市许可。</p><p><br /></p><p>此外，按该药品的商品编码办理相关检验检疫和相关许可证件，以及符合海外进口要求。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>92、KN95口罩怎么出口欧盟吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>KN95属于非医用口罩，按正常货物申报出口，申报时体现“非医用”。</p><p><br /></p><p>须办理欧盟CE认证，中国境内具有口罩等防疫用品CE认证能力的认证机构名录，见Q99。</p><p><br /></p><p>以下是中国和欧盟口罩标准的对应，需要说明的是这种对应并不是严格的对应，并且中欧标准要求有差异，仅供参考。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>93、非医用口罩，印有FDA标志，可以出口吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>不可以。美国FDA为医用口罩，海关近期正在严查印有FDA字样申报为非医用口罩的货物。企业应如实申报。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>94、个人防护口罩欧盟的标准是什么?</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-autoskip="1"><section>个人防护口罩欧盟注册/认证准入要求：CE认证：（EU）2016/425（个人防护产品法规）2020/403/EU 关于COVID-19威胁范围内的符合性评估和市场监督程序。技术法规和标准名称：EN 149-2001+A1:2009《呼吸保护装置 颗粒防护用过滤半遮罩 要求、测试和标记》。</section></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>95、未如实申报或出口部合格医用口罩，会受到何种行政处罚吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>对于将医用物资伪报成非医用物资逃避检验的，或将C类快件中的一般商品伪报为货样广告品的，依法从重处罚；涉嫌构成犯罪的，移送地方公安机关追究刑事责任。</p><p><br /></p><p>出口属于掺杂掺假、以假充真、以次充好的商品或者以不合格进出口商品冒充合格进出口商品的，责令停止出口，没收违法所得，并处货值金额百分之五十以上三倍以下的罚款；构成犯罪的，依法追究刑事责任。</p></section></section></section></section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><br /></section></section></section><section data-brushtype="text"><strong>96、未获得药监局注册证书，但已获得国外相关标准认证，可以出口吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><section>根据5号公告，出口相关医疗物资应取得我国医疗器械产品注册证书，符合进口国(地区)质量标准要求。针对已获得国外相关标准认证，但尚未取得我国医疗器械产品注册证书的，建议企业向药品监督管理部门提出申请，及时获取注册证书。</section></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>97、个人可以向国外邮寄口罩等防疫物资吗？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>根据《海关法》第四十六条：个人邮寄进出境的物品，应当以自用、合理数量为限。根据《关于调整进出境个人邮递物品管理措施有关事宜的公告》（海关总署2010年第43号公告）：个人寄自或寄往港、澳、台地区的物品，每次限值为800元人民币；寄自或寄往其它国家和地区的物品，每次限值为1000元人民币。对于个人寄递出境的口罩等防疫物资，应当符合上述规定。邮寄出口的商业性邮件，应按照货物规定办理通关手续。</p></section></section></section></section></section></section></section></section></section><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>98、企业怎么向国外邮寄口罩等防疫物资呢？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>企业往国外寄递口罩等防疫物资，应当按照C类快件或普通货物办理通关手续。</p><p><br /></p><p>按照C类快件办理通关手续的，寄递货物单票价值应当低于5000元人民币（不包括运、保、杂费等），且不得包括以下四个情形：</p><p><br /></p><p>1.涉及许可证件管制的；</p><p>2.需要办理出口退税、出口收汇或者进口付汇的；</p><p>3.一般贸易监管方式下依法应当进行检验检疫的；</p><p>4.货样广告品监管方式下依法应当进行口岸检疫的。</p><p><br /></p><p>按照普通货物办理通关手续的，应当根据出口货物的具体种类，办理相应的通关手续。捐赠物资应参照普通货物办理通关手续。</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>99、中国境内具有防疫用品CE认证能力的认证机构有哪些？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>详见国家认监局《口罩等防疫用品出口欧盟及美国市场认证信息指南》（附：中国境内具有口罩等防疫用品CE认证能力的认证机构名录）</p><p>http://www.cnca.gov.cn/xxgk/hydt/202004/t20200404_58016.shtml</p></section></section></section></section></section></section></section></section><section data-color="rgb(63,"><section><section data-color="rgb(63,"><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-brushtype="text"><strong>100、已获美国FDA紧急使用授权（EUA)的中国口罩生产企业名单有哪些？</strong></section></section><section><section><section><section data-bcless="spin" data-bclessp="120" data-bdopacity="1%"><section><br /></section></section></section></section><section data-autoskip="1"><p>截止2020年4月17日，共计81家，详见下面网址，持续更新中。</p><p><br 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发表于 2020-10-14 12:26:10