孟冬平接受央视、凤凰卫视等采访 就12号公告进行解读

　　来源：中国医药保健品进出口商会

　　孟冬平副会长接受央视、凤凰卫视记者采访

　　Vice President Meng Dongping interviewed by CCTV & Phoenix

　　前言

　　继中国商务部等三部委发布关于加强医疗物资出口管理的5号公告以后，4月25日，商务部联合海关总署、国家市场监督管理总局三部委再发布12号公告，加强包括非医用口罩在内的防疫物资质量监管、规范出口秩序，同时允许更多产品符合国外质量标准和注册要求的企业参与出口，进一步激发了市场的活力。公告引发国内外广泛关注和热议。近日，孟冬平副会长接受了央视新闻、CGTN、凤凰卫视等三家媒体的联合采访，就12号公告等相关政策及实施问题进行了解读。 

　　Introduction

　　Following the Notice No.5 issued by three government bodies including the Chinese Ministry of Commerce， on April 25， the Chinese Ministry of Commerce， Chinese General Administration of Customs and the Chinese State Administration for Market Regulation jointly released the Notice on Ensuring Quality of Exported Anti-epidemic Supplies （No.12）， to enhance quality supervision of exported medical supplies including face masks （non-medical use）， ensure export order， and allow export of products meeting overseas quality standards and registration requirements， thus further injecting vigor into the market． The Notice attracted wide attention at home and abroad． Recently， Vice President Meng Dongping of CCCMHPIE received the joint interview by CCTV NEWS， CGTN and Phoenix TV， and offered insights on related policies （including the Notice No.12） and implementation issues．

　　01

　　一、请介绍下中国口罩出口的整体情况？

　　I． What is the overview of China’s mask exports？

　　随着新型冠状病毒疫情在全球不断蔓延和扩散，越来越多国家向中国提出帮助的请求。截止到目前，我们已经通过商业化采购的方式，向191个国家和地区出口了防疫物资，根据海关统计，今年3月1日到4月25日期间，全国共验放出口主要防疫物资价值550亿元，其中仅口罩产品就包括了211亿只。目前，仅口罩单日出口量就已近14亿只，远远高于5号公告实施前的2.24亿只，而且还在呈现不断上升的趋势。

　　很多国家以各种方式向我们表达谢意，感谢中国社会，从政府到企业为支持世界各国抗击疫情所付出的巨大努力，在满足国内防控需要的同时，尽最大努力为世界各国商业采购需求提供支持，由中国制造的口罩在帮助全球应对疫情工作更是发挥了重要作用。

　　As COVID-19 spreads and proliferates across the world， an increasing number of countries are asking China for help． So far， we have exported anti-epidemic supplies to 191 countries and regions through commercial procurement． According to Customs statistics， from March 1 to April 25， China inspected and released related exports worth RMB 55 billion， including 21.1 billion masks． Currently， the daily mask exports are close to 1.4 billion， way higher than the 224 million before the introduction of Notice No.5 and are still growing．   

　　Many countries have expresses their appreciation for China in various ways， recognizing the enormous efforts of the Chinese society from the government to the business in support of the fight against the virus all over the world， not least the key role of China-made masks in the global response despite domestic needs in prevention and control．

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　　二、关于产品的质量要求和合规性问题。是否有质量问题（出现争议的主要原因是什么）？

　　II． Regarding product quality requirements and compliance， are there quality issues （what is the main cause of disputes）？

　　中国政府高度重视出口产品的质量和合规问题。疫情爆发后，各国纷纷向中国求援，大量的防疫物资开始出口到世界各地。商务部联合多个部委，连续发布5号公告和12号公告，对包括口罩、防护衣、新冠病毒检测试剂盒等医用防疫物资、非医用口罩等重点产品的出口质量标准提出了明确要求。12号公告更是对5号公告进一步完善和优化，允许多种贸易形态方式的出口。

　　The Chinese government takes very seriously the quality and compliance of export products． Upon requests for help from across the world after the outbreak， large quantities of anti-epidemic supplies were exported worldwide． In concert with several departments， MOFCOM successively issued Notice No.5 and No.12， laying down express export quality requirements for medical supplies such as face masks， gowns and testing kits and non-medical face masks， among other key products． In particular， improving on and optimizing No.5， No.12 allows export in multiple trade modes．

　　5号公告和12号公告都非常清晰地表达了中国政府的态度和主张，那就是，我们将严把出口质量关，严格规范贸易行为，确保出口的防疫物资产品的安全有效。中国是医疗健康产品，特别是医疗防疫物资的生产和出口大国，我们曾经因为受疫情影响，经济受到严重打击。但是，在这个疫情防控的特殊时期， 我们没有一味追求出口的规模数量，而是反复强调出口产品的质量安全性和合规性。在有序组织出口的同时，我们强调尊重各国的法律法规，尊重市场规律和贸易竞争法则。

　　Both notices have made clear the attitude and stand of the China government that we will secure export quality and hold trade conduct to strict regulation to ensure the safety and efficacy of anti-epidemic exports． China is a major producer and exporter of medical and health products， especially anti-epidemic supplies． Our economy was hit hard by the epidemic． Nonetheless， at this special time of epidemic combat， rather than going after export quantities and numbers， we are emphasizing time and again export quality safety and compliance． While organizing for orderly exports， we are stressing respect for local laws and regulations， the market law and trade competition rules．     

　　按照国际贸易通行惯例，对于进口产品的质量安全监管是完全由进口国负责的。但是两个公告，仍然提出明确要求，出口的医疗防疫物资应符合进口国家和地区的质量标准要求。其宗旨，就是要把符合各国质量标准要求的防疫物资尽快输送到最需要的地方，驰援世界各国抗击疫情，体现了中国政府的客观、务实、负责任的态度，更是我们对生命健康的尊重和承诺。

　　According to common practices in international trade， the importing country is wholly responsible for regulating the quality of imported products． However， the two Notices still clearly require that the exported medical and epidemic prevention supplies should comply with the quality standards and requirements of the importing country and region． The aim is to deliver epidemic prevention materials that meet the quality standards of the countries to the places where they are most needed as soon as possible and to help countries around the world in their fight against the epidemic． It shows that an objective， pragmatic and responsible attitude by the government of China and its respect and commitment for life and health．

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　　三、关于12号公告和5号公告的关系

　　III． The relations between Notice No． 12 and No． 5

　　3月31日发布的5号公告，主要是针对医用口罩等五类医疗防疫物资明确了出口质量监管措施， 相比5号公告，12号公告进一步完善和优化，更具包容性。12号公告再一次强调了出口防疫物资的质量标准和安全合规性。公告在继续规范对口罩等五类重点医疗防疫物资出口的基础上，特别强化了对非医用口罩的出口监管。以确保产品符合中国或国外的质量标准要求；公告增设了需要进出口双方的共同声明，进口方要承诺接受所购产品的质量标准，且要确保不用于医用用途。这表明，中国政府尊重市场原则，充分考虑到各国独立的监管体系和质量标准要求，针对仅在中国生产、不在中国销售使用的医疗物资，尤其是那些长期采用该运营模式的企业，采取相对灵活的政策，对于已获得国外相关标准认证（如CE认证或美国FDA认证）、但尚未取得中国医疗器械产品注册证书的疫情防控用品是准予出口。通过买卖双方签署共同声明，更是希望企业作为市场经营主体，能够承担起自身所应承担的责任和义务。两个公告相互衔接，同步执行。

　　Notice No． 5 issued on March 31 mainly specified export quality regulatory measures for five categories of medical and epidemic prevention supplies such as surgical face masks． Compared with Notice No． 5， Notice No． 12 is further improved and more inclusive． Notice No． 12 again stresses the quality standards and safety compliance of epidemic prevention exports． While continuing to regulate the export of five key medical and epidemic prevention supplies， including masks， the Notice has strengthened the export regulation of non-surgical masks in particular to ensure that the products are consistent with Chinese or foreign quality standards and requirements． The Notice also added that a joint statement is required for both the importer and exporter． The importer should commit to accept the quality standard of the products they purchase and ensure that such products will not be used for medical purposes． This shows that the government of China respects market principles and fully accommodates the independent regulatory systems and quality standard requirements of other countries． As for medical supplies that are only produced and not sold and used in China， flexible policies may be adopted， especially for companies that have been adopting such operating models for a long time． The epidemic prevention and control supplies that have already achieved the certification under relevant foreign standards， such as CE or FDA certification， even though without medical device registration certificate in China， are allowed for export． By asking the sellers and buyers to sign a joint statement， we hope that companies would shoulder their due responsibilities and obligations as market players． The two notices are connected and are implemented at the same time．

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　　四、关于外媒炒作的所谓中国产品质量问题

　　IV． The quality of Chinese products under foreign media hype

　　我注意到，不时有一些境外媒体报道中国防疫物资产品有质量问题，我们对此高度重视。不久前，我曾在就5号公告接受采访中已提到：我们对多起报道的所谓质量问题进行了追踪，后来经调查后发现大多是因为在进口、分发、使用等多个环节，买卖双方或者当事人对相关产品的规格、标准、要求不尽了解，或者没有严格按照合同列明要求来合理使用，造成了不必要的后果和影响，其实并不是真正的质量问题。

　　We have noticed that， from time to time， there is some foreign media coverage stating the quality problem with Chinese epidemic prevention supplies and we attach great importance to such issues． Not long ago， during my interview on Notice No． 5， I have mentioned that we tracked several cases being reported with the so-called quality problems． After investigations， we found that in most of such cases， it was because that during import， distribution and usage， the sellers and buyers or people involved do not fully understand the specifications， standards and requirements of relevant products， or fail to strictly follow the instructions of the contract， causing unnecessary consequences and impacts． As a matter of fact， these are not real quality issues．

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　　五、关于标准问题

　　V． On standards

　　1．中国KN95口罩是否等同于美国的N95？

　　1.Are Chinese KN95 masks equivalent to US Surgical N95？

　　国标KN95虽然和美国医用N95过滤率都为95%，但更多属于民用（或公众使用），不防喷溅，通常用于一般防护灰尘和小颗粒，价格相对较低，是不能用于医疗机构中医护人员、尤其是ICU等重污染区，我们所说的医院红区。

　　The KN95 masks under the Chinese standard can filter 95% of particles just like US Surgical N95 masks， but it is usually for the general public． It is not fluid resistant． It is usually used for general protection against dust and small particles under a relatively low price． It cannot be used for medical personnel in medical institutions， especially in heavily polluted areas such as ICU， what we call hospital red zones．

　　美国医用N95口罩（或欧标医用FFP2口罩）有涂层技术，防喷溅阻隔飞沫，价格是比较贵的。原则上在医院发热门诊、隔离留观病区、隔离病区和隔离重症监护病区等以及有可能产生气溶胶的操作时使用，数量相对较少。

　　US Surgical N95 masks ， use a special coating technology to keep them fluid resistant and block droplets． It is relatively expensive． In principle， it is used in the fever clinic， quarantine observation ward， quarantine ward and quarantine ICU of the hospital， as well as during the operations that may generate aerosol． It is relatively small in quantity．

　　其实真正与美国医用N95口罩对等的是中国的医用n95，中国标准的医用防护口罩，而不是kn95，也就是说一个是民用，一个是医用，所以也提醒进口方一定要严格按照合同的列明的相关要求来进行适当的操作。

　　In fact， the Chinese masks equivalent to US N95 medical masks are Chinese medical protective masks， instead of KN95 masks． KN95 is for daily use， while medical protective masks is for medical purposes． Therefore， we would like to remind importers that they should use the masks properly in strict accordance with the requirements set out in contracts．

　　2．中国KN95口罩与欧洲FFP2口罩有何区别？KN95口罩适用于哪些场合？

　　2.What are the differences between Chinese KN95 masks and European FFP2 masks？ What occasions are KN95 masks suitable for？

　　由于国内的KN95级别的口罩是针对盐性颗粒物进行的测试，而没有通过油性颗粒物进行，只有KP95级别的口罩才会进行油性颗粒物的测试，所以只通过KN95级别的测试很可能没有办法通过FFP2级别检测的石蜡油气雾测试的。这其中N表示“Non-oil”（不防油性颗粒物）。而P指的是“Oil protective”（防油性颗粒物）

　　Chinese KN95 masks are tested for protection against saline particles， not against oily particles， and only KP95 masks are tested for protection against oily particles． Therefore， it is likely that the masks that have passed KN95 tests may fail to pass the FFP2 test for protection against paraffin oil aerosol． Here， N stands for “Non-oil” （non-resistant to oily particulates）， and P for “Oil protective” （resistant to oily particulates）．

　　KN95口罩适合防护固体和非油性颗粒物、液体物及微生物，如煤尘、水泥尘、酸雾、油漆雾等。但是对油烟、油雾、沥青烟、焦炉烟、柴油机尾气中的颗粒物等的防护能力却有限。

　　KN95 masks are suitable for protection against solid and non-oily particulates， liquid and microorganisms such as coal dust， cement dust， acid fog， paint fog， etc． However， they provide limited protection against oil smoke， oil mist， asphalt smoke， coke oven smoke， particulates in diesel exhaust， etc．

　　3．请问中国口罩标准和欧洲、美国的口罩标准有何不同？

　　3.What are the differences between Chinese mask standards and European and US mask standards？

　　根据规定，出口的非医用口罩产品必须符合中国本地的产品标准如GB2626-2006和GB/T32610-2016等，或者要符合进口国家或地区的质量标准要求，比如欧盟的2016/425指令，也就是通常说的个人防护用品指令或PPE指令。

　　According to regulations， exported non-medical masks must conform to Chinese product standards such as GB2626-2006 and GB/T32610-2016， or meet the quality standard requirements of the importing country or region， such as the EU Regulation 2016/425， which is known as the Personal Protective Equipment Regulation （PPE Regulation）．

　　中外各国对产品级别的划分和对应的指标要求是不能完全等同的。比如，非医用口罩为例。呼吸阻力就有区别的。如GB2626把产品根据泄漏率和口罩本身的过滤效率分为三个等级，每一等级又分成盐性颗粒物和油性颗粒物；GB32610则把产品分为ABCD四个级别；而EN149只把产品分为FFP1、FFP2和FFP3三个级别，所以不是一一对应关系。

　　The product classification and corresponding indicator requirements in China and foreign countries cannot be equated to one another． For example， different non-medical masks have different breathing resistance． GB2626 classifies products into three levels according to the leakage rate and filtering efficiency of the mask， and products at each level are classified as saline particulate-resistant and oily particulate-resistant； GB32610 classifies products into four levels （A， B， C， D）； and EN149 only classifies products into three levels of FFP1， FFP2 and FFP3． Therefore， the standards do not correspond to one another．

　　国内关于民用口罩的标准有GB 2626-2006 《呼吸防护用品—自吸过滤式防颗粒物呼吸器》和GB/T 32610-2016 《日常防护型口罩技术规范》都是属于民用口罩的范畴，他们和GB 19083-2003《医用防护口罩技术要求》有着很大的区别。而欧盟的民用口罩检测标准是EN149-2001+A1-2009《呼吸防护装置颗粒防护用过滤半面罩要求、检验和标记》，医用口罩标准是EN 14683。美国是应用的NIOSH相关标准。所以从产品级别分类方法、具体测试指标等多个层面来看，各国的测试标准还是有许多区别的，不能简单的等同。

　　For the standards of masks for daily use， China has GB 2626-2006 “Respiratory Protective Equipment—Non-Powered Air-Purifying Particulate Respirator” and GB/T 32610-2016 “Technical Specifications of Daily Protective Masks”． They are both for masks for daily use， vastly different from GB 19083-2003 “Technical Requirements for Medical Protective Face Masks”． The European Union‘s testing standard for masks for daily use is EN149-2001+A1-2009 “Respiratory Protective Devices - Filtering Half Masks to Protect against Particles - Requirements， Testing， Marking”， and its standard for medical face masks is EN 14683． The US applies relavant NIOSH standards． Therefore， there are lots of differences in different countries’ testing standards in terms of the classification of product levels and specific testing indicators． We cannot simply equate one testing standard with another．

　　医疗防疫物资属于监管类产品，各国对产品的规格和检测要求并不相同，中国对防疫物资的标准要求是比较高的，但对于医疗产品的审批、标准管理、检验检测与认证等方面是有自己独立的一套管理体系，是不能与国外完全等同的。

　　The supply of medical protective products is a highly regulated sector and each country has its own standards and inspection requirements． Chinese standards for medical protective products are relatively higher than many other countries． China forms its own regulatory system covering the approval， standard management， inspection and certification of products， which is not completely the same with foreign ones．

　　4．中国出口的试剂盒检测效果如何？为何欧方在使用中准确率较低？

　　4.How effective are the test kits exported from China？ How do you explain the relatively low accuracy of these test kits used by European countries？

　　目前，有相当数量的中国的新冠病毒检测试剂盒产品出口到欧洲、亚洲、拉美等多个国家地区，并获得了积极评价。但是，我们也注意到一些关于中国检测试剂盒检测效果的负面报道。这里我想说的是，新冠抗体检测试剂的储存、运输和使用均有严格要求，必须由专业人员按照产品说明规范进行操作，否则将导致检测准确率偏低或出现偏差。

　　Huge quantities of test kits are being exported from China to Europe， Asia and Latin America and have been well-received by relevant countries and regions． Nevertheless， we have noted some negative coverage of the effect of the Chinese test kits． There are strict requirements for the storage， transportation and usage of the novel coronovirus antibody test kits． Antibody testing must be carried out by professional staff in accordance with product instructions， otherwise low accruacy or errors might occur．

　　此外，由于核酸检测和抗体检测（胶体金法）都是定性检测新冠病毒的试剂， 目前国外客户使用时容易混淆，此前西班牙方面的检测试剂争议问题就是例子。核酸检测和抗体（胶体金法）都是从来定性检测新冠病毒的。胶体金可以通过肉眼检出结果，15分钟即可出结果，适用于大范围普查；核酸检测是要通过实验室设备来完成的，需要 2-8小时检出结果，多适用于个体病例的确诊。

　　Besides， both nucleic acid tests and antibody tests are qualitative testing． Foreign end-users could eaily confuse these two different types of testing， as exemplified by the dispute over test kits in Spain． An antibody test could return results in as soon as 15 minutes and could be easily identified by the human eye． It is more adapted to mass testing． The nucleic acid testing is more suitable for individual cases． A nucleic acid test normally takes 2 to 8 hours and must be conducted in labs．

　　产生问题的主要原因是：第一检测时期不当。胶体金检测的前提是需要患者体内病毒感染后产生抗体才能检测。早期如机体没有产生免疫抗体，则不适用，无法检测出结果。相比之下，核酸检测作为确诊新型冠状病毒感染的“金标准”，是直接检测病毒的遗传物质，只要采集部位积累了一定的病毒量（可被检测，每家公司产品灵敏度不同），就可以用荧光PCR的方法学检测出来，不需要等机体产生免疫，比胶体金法更早发现。第二是采样不当。核酸检测也会出现假阴性现象，主要是由于医生采集样本部位不够深或者采集方式不对，造成样本病毒数量不够，而无法检测出结果。

　　The antibody testing is less accurate partly due to the inapproriate timing for testing． Such tests could only work on the premise that the patient was infected and has developed antibodies against the virus． If the patient is infected but has not generated antibodies yet， the antibody testing would not work． By contrast， as the “gold standard” for confirming SARS-CoV-2 infection， the nucleic acid testing can directly trace the viral genetic material． The PCR method would detect the virus as long as a certain amount of virus is accumulated in the sample collected （detection sensitivity varies among products produced by different companies）． Compared with the antibody testing， the nucleic acid testing could detect the virus at an earlier stage without waiting for the patient to develop antibodies． The second reason for the accuracy issue is related to improper sampling． Nucleic acid tests may also give false negative results if the virus collected in the sample is only present in very small amounts and not able to send a strong enough signal to turn the test positive． This is largely due to incorrect sampling or the fact that the point where doctors collect the sample is not deep enough in the patient’s body．

　　为避免类似问题发生，12号公告要求出口方和进口方签署共同声明，确认双方接受产品质量标准，进口方承诺所购非医用口罩不用于医用用途。我们提醒，采购方在进口时提起对产品进行检验检测，并在使用过程中严格按照合同列明的操作规范、要求及适用范围正确使用。对于出现的有关问题，建议双方保持沟通对话，共同协商解决。

　　To avoid similar problems， Notice No.12 requires a joint declaration to be signed by the exporter and importer to confirm that relevant product quality standards are accepted by both sides， and the importer commits that the non-medical face masks purchased would not be used for medical purposes． We caution buyers to carry out testing and inspection on the imported products and use these products in strict accordance with the operational instructions， requirements and scope of application specified in the contracts． In case of any problems， we suggest the two sides resolve the disputes through communication and consultation．

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　　六、关于取得国外标准认证或注册的企业名单

　　VI． About the List

　　1．国际社会积极评价公告成效

　　1.The Notice has been positively received by the international community

　　公告不断推出合规企业名单，有效地解决了海外采购方对货源信息不畅、货源真伪难辨带来的困惑和担忧，收到市场的广泛欢迎。在这个特殊和紧急的情况下，一批企业脱颖而出，中国制造的产品再次迎来了机遇和挑战。这些企业的之所以受欢迎，很大程度取决于他们对相关行业标准和国际准入制度的了解程度，并且通过一定时间的积累和准备后，认真执行行业标准，能够提供符合相关规定的出口产品。

　　The Notice has enjoyed warm market reception for it offers a constantly updated list of qualified companies， which effectively helps foreign buyers dispel confusion and concerns due to lack of information and of the ability to identify counterfeit goods． At this unusual and urgent juncture， some Chinese companies have come through， a sign of both opportunities and challenges for made-in-China products． The popularity of these companies derives mainly from their knowledge of relevant industry standards and international market access systems and their capacity to translate that knowledge through preparation into qualified products for export．

　　当然，我们也注意到，公告发出后出现的一些后续问题。我们一方面鼓励帮助企业按照要求到药监部门注册，同时密切关注市场的动态，积极收集企业的信息并及时向主管部门反映，通过建言献策，协调推动，寻求解决办法。

　　That said， we are also aware of the issues arising from the Notice． We encourage and help Chinese companies to register with local medical products administrations． At the same time， we report market feedback and company requests to relevant government departments to work out solutions together．

　　2．针对12号公告，医保商会的名单审核流程是怎么安排的？

　　2.How will CCCMHPIE review the list in accordance with the Notice？

　　医保商会受政府主管部门的委托，组织行业专家对各省市商务主管部门收集上来的生产企业自荐表，并进行上报信息的初步汇总，通过专家评审的方式对上报的材料整理和核对。取得国外标准认证或注册的生产企业清单由地方商务主管部门初步审核后，直接报送至国家医疗物资商业出口工作机制办公室（商务部外贸司），抄送我会。我会组织专家核实确认相关资质后，将结果报送商务部，并将根据商务部确认情况进行动态更新（不定期）。

　　Entrusted by its supervising government department， CCCMHPIE invites industry experts to review and cross-check manufacturers’ self-recommendation forms collected by local commerce departments． The lists of manufacturers with certification or authorization from other countries， after initial review by local commerce departments， will be submitted to the Office of the National Mechanism for Medical Supplies Export （Department of Foreign Trade， Ministry of Commerce） and copied to CCCMHPIE which will invite experts to confirm their qualifications， submit the lists to the Ministry of Commerce （MOFCOM）， and provide updates （at random intervals） based on MOFCOM’s feedback．

　　在这个过程中，我们需要对企业中英文名称、经营企业代码、产品名称（含规格、型号）、已获得国外认证或注册情况说明和联系人、联系方式等信息进行统计。这其中最重要的一个环节就是对企业已经获得的相关证书资质合规性审查。

　　At CCCMHPIE， we will collect and compile information regarding the Chinese and English names of the companies， their business codes， names， specifications and models of products， status of certification or authorization in other countries， and contact information． The most important link in this process is compliance review of the licenses obtained by the companies．

　　12号公告发布后，受到国内外的广泛关注。商会每天接到大量咨询电话。为了让大家对12号公告的内容有进一步了解，我会昨天已通过商会网站和微信公众号就12号公告热点问题进行了回应，也以流程图的形式就相关工作程序及我们会担的工作进行了说明。目前，整个材料提交审核过程是非常清晰、透明的。如有任何疑问，可以联系与所在地商务部门进行咨询。

　　Ever since its release， the Notice has triggered considerable attention home and abroad， and CCCMHPIE has received numerous phone calls for more information． To help people better understand it， CCCMHPIE posted answers to frequently asked questions on its website and official WeChat account and illustrated relevant procedures and CCCMHPIE’s work in flowcharts， offering a clear and transparent view of the submission and review processes． If you have any further question， you may contact your local commerce departments．

　　商会在具体组织这项工作时，也是将医用和非医用分为两个工作组。两者采用的标准以及认证要求不一样，欧美分别有不同的法规。

　　CCCMHPIE has set up two working groups， one for products for medical use， and the other for non-medical use， due to separate standards， independent certification requirements and different applicable laws and regulations in Europe and the US．

　　截止到4月28日，已在网站上公布的取得国外标准认证或注册的企业223家，具体包括：非医用口罩企业62家；医疗防疫物资企业161家。

　　As of April 28， we have listed 223 companies with certification or authorization from other countries， of which 62 are manufacturers of face masks for non-medical use， and 161 are producers of medical supplies．

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责任编辑：马婕