zh-cn	商务部 海关总署 药监局有关司局负责人就有序开展医疗物资出口公告有关问题答记者问 
en-us	Heads of Related Departments of the Ministry of Commerce, the General Administration of Customs, and the National Medical Products Administration Addressing Media Questions on the Orderly Export of Medical Supplies 

zh-cn	3月31日，商务部会同海关总署、药监局
en-us	On March 31, the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC) and the National Medical Products Administration (NMPA) 

zh-cn	发布《关于有序开展医疗物资出口的公告（2020年第5号）》。
en-us	jointly published the Announcement on the Orderly Export of Medical Supplies (No.5 2020). 

zh-cn	三部门有关司局负责同志就公告有关问题回答了记者提问。 
en-us	Officials in charge from the three ministries met with the press. 

zh-cn	一、在当前形势下，三部门为什么要出台有序开展医疗物资出口，加强质量监管的公告？
en-us	Q1.Why do MOFCOM, the GAC and the NMPA publish an announcement regarding the orderly export of medical supplies and more stringent regulation on quality in the current situation? 

zh-cn	有什么考虑？ 
en-us	What are the considerations behind? 

zh-cn	随着新冠肺炎疫情在全球快速蔓延，许多国家面临疫情严峻挑战，
en-us	Many countries have been faced with the pressing challenge of the rapidly spreading COVID-19 pandemic, 

zh-cn	我们对此感同身受。
en-us	and China is empathetic towards their difficult circumstances. 

zh-cn	防疫无国界，
en-us	Epidemic prevention and control efforts should not be separated by borders; 

zh-cn	抗击疫情需要国际社会携手合作、共同应对。 
en-us	the international community should join hands and stand in unison against the outbreak. 

zh-cn	在习近平主席亲自指挥、亲自部署下，
en-us	With President Xi Jinping personally overseeing and guiding the response, 

zh-cn	经过全国人民艰苦努力，中国境内疫情防控形势持续向好，
en-us	and with the arduous efforts of the whole nation, China is making constant progress in preventing and controlling its domestic outbreak. 

zh-cn	我们在继续做好国内疫情防控的同时，积极深化疫情防控国际合作，
en-us	In the meantime, we are also deepening international cooperation on prevention and control, 

zh-cn	努力为国际社会提供力所能及的支持和帮助。
en-us	offering support and assistance to the rest of the international community to the best of our ability, 

zh-cn	这既是回馈国际社会前期对中国抗疫的支持，
en-us	It is our way of repaying other countries’ support at the outset of the outbreak, 

zh-cn	也是积极支持全球抗疫、构建人类命运共同体的重要举措。 
en-us	and an important step to back up global responses and build a community with a shared future for mankind. 

zh-cn	医疗物资的质量安全直接关系人的生命健康。
en-us	Quality and safety of medical supplies bear on people’s life and health. 

zh-cn	中国政府一贯高度重视医疗物资质量安全，对相关产品实行严格管理。
en-us	The Chinese government attaches great importance to the quality and safety of medical supplies, as shown by our strict regulation governing relevant products. 

zh-cn	在疫情防控特殊时期，进一步强化质量监管、规范出口秩序尤为重要。
en-us	In such an epidemic, it becomes ever more crucial to step up quality monitoring and supervision and to better regulate export. 

zh-cn	按照党中央、国务院部署，商务部会同海关总署、药监局于3月31日发布公告，
en-us	Following the direction of the CPC Central Committee and the State Council, MOFCOM, the GAC and the NMPA jointly published an announcement on March 31, 

zh-cn	要求出口的检测试剂、医用口罩、医用防护服、呼吸机、红外体温计等5类产品
en-us	requiring that test reagents, medical facial masks, medical protective suits, ventilators and infrared thermometers for export 

zh-cn	必须取得国家药品监管部门相关资质，符合进口国（地区）质量标准要求。
en-us	must be certified by state medical products administration departments and conform with the quality requirements of the importing country or region. 

zh-cn	如医疗物资出口中出现质量问题，我们将会同相关部门认真调查，
en-us	We will work with relevant departments to investigate all non-conforming exported products as they emerge. 

zh-cn	发现一起，查处一起，依法惩处，绝不姑息，更好发挥医疗物资的重要作用。 
en-us	The cases will be handled in accordance with law, with no one left out, to ensure that the medical supplies are better utilized. 

zh-cn	同时，我们希望国外采购方选择在我国药品监督管理部门注册的产品的供应商，
en-us	Meanwhile, foreign purchasers are encouraged to choose the suppliers that are registered at our medical products administration departments. 

zh-cn	并在产品使用前进行相应的质量检验，严格按照产品适用范围和操作规程正确使用。
en-us	Due quality inspections should be carried out prior to use, and the products should be used for their intended purposes and according to their operation specifications.

zh-cn	如在采购和使用中出现有关问题，建议双方企业按商业化原则妥善协商解决。
en-us	We recommend that any issue that may arise when buying or using these supplies should be properly discussed and settled based on commercial principles. 

zh-cn	我们愿同国际社会共同努力，为医疗物资有序出口营造良好环境，更好地支持全球抗击疫情。 
en-us	We are willing to work with the rest of the international community to foster a sound and orderly environment for the export of medical supplies that underpins global response. 

zh-cn	二、如果医疗物资没有获得我药品监督管理部门的注册证书，
en-us	Q2.If certain medical supplies are not granted a registration certificate from China’s medical products administration departments, 

zh-cn	但获得国外相关标准认证，能否出口？
en-us	but are certified under relevant foreign standards, are they allowed for export? 

zh-cn	根据公告规定，出口相关医疗物资应取得我国医疗器械产品注册证书，
en-us	It is required in the Announcement that medical supplies to be exported should be granted a registration certificate and, 

zh-cn	符合进口国（地区）质量标准要求。
en-us	at the same time, conform with the quality standards and requirements of the importing country or region. 

zh-cn	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情况，
en-us	For those medical supplies which are certified under relevant foreign standards but are not granted a registration certificate for medical devices and products in China, 

zh-cn	建议相关企业按规定向药品监督管理部门提出申请。
en-us	companies should file an application to medical products administration departments, as required. 

zh-cn	需要说明的是，本公告中公布的我国相关医疗器械产品注册信息截至2020年3月31日，
en-us	It should be noted that the registration information of Chinese medical devices and products included in the Announcement are collected as of March 31, 2020. 

zh-cn	国家药监局将动态更新相关信息，如需查询请登录国家药监局官网（www.nmpa.gov.cn/WS04/CL2582/）。 
en-us	The NMPA will provide updates constantly, which will be available on its official website (www.nmpa.gov.cn/WS04/CL2582/). 

zh-cn	三、公告出台后，海关采取了哪些措施做好医疗物资出口通关工作？ 
en-us	Q3.What measures have the GAC taken for the export clearance of medical supplies? 

zh-cn	当前，新冠肺炎疫情在全球多个国家暴发。
en-us	COVID-19 has broken out in many countries around the world. 

zh-cn	做好医疗物资出口工作，是积极支持有关国家抗击疫情、深化疫情防控国际合作的重要举措。
en-us	The export of medical supplies is thus an important step to support epidemic response in certain countries and to deepen international cooperation on disease prevention and control. 

zh-cn	在国务院联防联控机制统一领导下，
en-us	Under the coordinated leadership of the State Council inter-agency prevention and control task force, 

zh-cn	3月31日，商务部、海关总署、国家药品监督管理局联合发布公告，
en-us	MOFCOM, the GAC and the NMPA jointly published an announcement on March 31, 

zh-cn	支持引导国内有资质的企业按照市场化原则，依法有序开展医疗物资出口，
en-us	encouraging qualified Chinese companies to export medical supplies according to law, in an orderly manner and based on market principles, 

zh-cn	切实维护医疗物资出口市场秩序，树立良好形象。
en-us	so as to play a positive role by stabilizing the export market of medical supplies. 

zh-cn	为推动工作的落实，海关总署成立了专项工作组，强化医疗物资出口工作的组织领导，
en-us	In this light, the GAC has formed a special working group to enhance coordination and leadership over the export of medical supplies.

zh-cn	加强监管优化服务，严格按照有关部门确定的出口医疗物资合格企业名单，依法监管验放；
en-us	We have stepped up regulation and optimized services by inspecting and releasing medical supplies according to law and to the list of qualified businesses, 

zh-cn	加强知识产权海关保护，严厉打击出口侵权医疗器械、口罩等防疫商品的违法行为；
en-us	and strengthened protection for intellectual property rights by cracking down on the export of infringing products such as medical devices and facial masks. 

zh-cn	支持企业通过电子方式填报相关证明；
en-us	Companies can file certifications in electronic forms. 

zh-cn	提高查验作业的精准度和有效性。
en-us	The inspection procedures have also been upgraded to be more precise and effective.

zh-cn	此外，海关还积极通过12360海关热线等多种渠道，
en-us	Besides, the GAC have been leveraging multiple channels, including the 12360 “Customs Hotline”, 

zh-cn	及时解决企业通关过程中遇到的问题和困难，为有资质的企业提供更好的服务，支持国际社会共同抗击疫情。 
en-us	to address the problems faced by companies in customs clearance and provide better services for qualified enterprises, contributing our part to global response against the outbreak. 

zh-cn	据统计，3月1日以来，全国共验放出口口罩、防护服等主要防控物资27.7亿件，价值62.9亿元人民币。
en-us	Statistics show that since March 1, Chinese customs have inspected and released 2.77 billion masks, protective suits and other major medical supplies for export, with a total value of RMB￥6.29 billion. 

zh-cn	四、在《公告》发布后，企业通关手续有什么变化？ 
en-us	Q4.After the Announcement is released, what are the changes to the business customs clearance procedures? 

zh-cn	在《公告》发布前，企业申报出口、医用口罩、医用防护服、呼吸机、新型冠状病毒检测试剂、红外体温计时，
en-us	Before the publication of the Announcement, when enterprises declare export for medical masks, medical protective suits, ventilators, COVID-19 test reagents and infrared thermometer, 

zh-cn	可不提供随附单证，海关无监管证件口岸验核要求，
en-us	there is no need for them to provide the accompanying documents. The customs department does not have the port inspection requirements for regulatory documents. 

zh-cn	审核时如有需要再提交发票、装箱清单等单证。 
en-us	The invoices, packing lists and other documents would only need to be submitted if the review warrants so. 

zh-cn	《公告》发布以后，企业申报出口上述5种医疗物资时，
en-us	After the publication of the Announcement, when enterprises declare the export of the above five types of medical supplies, 

zh-cn	在通关环节与之前相比需要提供《公告》中所列的出口医疗物资书面或电子声明、医疗器械产品注册证书。
en-us	they need to provide the written or electronic declaration for the exported medical supplies and the registration certificates for medical devices and products listed in the Notice in the customs clearance process, compared with the previous provisions. 

zh-cn	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。 
en-us	The customs will inspect and release the goods based on the registration certificates for medical devices and products approved by the medical products administration department. 

zh-cn	海关将继续加强监管优化服务，支持有资质企业扩大出口，支持国际社会共同防控疫情，
en-us	The customs will continue to strengthen regulation and optimize services, support qualified enterprises to expand exports, support the international community to jointly prevent and control the COVID-19, 

zh-cn	也提醒企业严格产品质量管控，坚持诚信经营、合规经营，在出口时提前准备好相关单证。 
en-us	while also reminding enterprises to exercise strict quality control, adhere to integrity and comply with rules in operations, and prepare relevant documents in advance before exporting. 

zh-cn	五、五大类出口防疫物资在国内批准情况 
en-us	Q5.Regarding domestic approval for the five types of exported medical supplies for COVID-19 prevention 

zh-cn	新冠肺炎疫情爆发后，国家药监局高度重视，迅速启动医疗器械应急审批程序，
en-us	Since the outbreak of COVID-19, the NMPA has attached great importance to this work and rapidly launched the emergency approval procedure for medical devices. 

zh-cn	并要求各省级药品监管部门在加强产品质量监管的同时，积极启动辖区内第二类医疗器械应急审批工作。
en-us	The NMPA requires provincial medical product regulatory authorities to actively start the emergency approval of Class II medical devices within their jurisdictions, while strengthening product quality supervision. 

zh-cn	各级药品监管部门对新冠病毒检测试剂、医用口罩、医用防护服等产品以及保证产品安全、创新审查方式，
en-us	For the COVID-19 testing reagents, medical masks, medical protective clothing and other products, medical product regulatory authorities at all levels have innovated their review methods 

zh-cn	并行开展注册检验、质量体系核查、注册资料审查，全力加快审评审批速度。 
en-us	and conducted registration inspection, quality system verification and review of registration information in parallel, so as to speed up the review and approval with all their strength ,

zh-cn	按照“统一指挥、早期介入、随到随审、科学审批”的原则，
en-us	in accordance with the principle of “unified command, early intervention, timely review, science-based approval”

zh-cn	有效、质量可控的要求，
en-us	as well as the requirement to ensure product safety and effectiveness and exercise quality control

zh-cn	截至2020年3月31日，国家药监局应急审批批准25个新冠病毒检测试剂，
en-us	As of March 31, 2020, the NMPA approved 25 COVID-19 detection reagents under the emergency procedure, 

zh-cn	包括17个核酸检测试剂，8个抗体检测试剂。
en-us	including 17 nucleic acid detection reagents and 8 antibody detection reagents. 

zh-cn	其中，抗体检测试剂产品由于其方法学特点，产品仅用作对新冠病毒核酸检测阴性疑似病例的补充检测，
en-us	Due to its methodological characteristics, antibody detection reagents are only used as a complementary test for suspected cases with negative results for the COVID-19 nucleic acid detection, 

zh-cn	或在疑似病例诊断中与核酸检测协同使用，
en-us	or in conjunction with nucleic acid test in the diagnosis of suspected cases. 

zh-cn	不作为新冠病毒感染者确诊和排除的依据，也不适用于一般人群的筛查。
en-us	It should not serve as a basis for the diagnosis and exclusion of COVID-19 infection, nor should it be used for screening the general population. 

zh-cn	抗体检测试剂仅限医疗机构使用。 
en-us	Antibody detection reagents are for medical institutions only. 

zh-cn	此外，国家药监局和各省级药品监管部门还批准国产呼吸机产品注册证67个，
en-us	In addition, the NMPA and provincial medical product regulatory authorities also approved 67 product registration certificates for domestic ventilators, 

zh-cn	国产医用防护服产品注册证302个，国产医用防护口罩产品注册证153个，
en-us	302 product registration certificates for domestic medical protective suits, 153 product registration certificates for domestic medical protective masks, 

zh-cn	国产医用外科口罩产品注册证549，国产一次性使用医用口罩产品注册证785个，
en-us	549 product registration certificates for domestic medical surgical masks, 785 product registration certificates for domestic disposable medical masks, 

zh-cn	国产红外体温计（含耳温计、额温枪）产品注册证共234个。
en-us	and 234 product registration certificates for domestic infrared thermometers (including ear thermometers and forehead thermometers). 

zh-cn	相关注册审批信息可在国家药监局网站上查询。 
en-us	The relevant registration and approval information could be found on the NMPA’s website. 

zh-cn	六、公告发布后，药监部门是否继续出具《医疗器械产品出口销售证明》 
en-us	Q6.After the publication of the Notice, will the medical product regulatory authorities continue to issue Certificates of Free Sale for medical devices and products? 

zh-cn	出口医疗器械质量，按照国际惯例，由进口国进行监管。
en-us	The quality of exported medical devices is regulated by the importing country in accordance with international practice. 

zh-cn	我国《医疗器械监督管理条例》第四十四条明确规定：
en-us	Article 44 of China's Regulations for the Supervision and Administration of Medical Devices clearly states that: 

zh-cn	“出口医疗器械的企业应当保证其出口的医疗器械符合进口国（地区）的要求。” 
en-us	“Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region).” 

zh-cn	在医疗器械产品出口的过程中，
en-us	In the process of exporting medical devices and products, 

zh-cn	部分进口国（地区）有时要求出口医疗器械的企业提供由企业所在国政府主管部门出具的销售证明。
en-us	some importing countries or regions sometimes require enterprises exporting medical devices to provide Certificates of Free Sale issued by the competent government departments of the country where the enterprises are located. 

zh-cn	为服务我国医疗器械生产企业产品出口，
en-us	In order to serve China’s medical device manufacturers in exporting products, 

zh-cn	药品监管部门根据企业需求出具出口销售证明，
en-us	the medical product regulatory authorities would issue a Certificate of Free Sale according to the needs of enterprises. 

zh-cn	这种销售证明属于服务性事项，不是许可事项，与产品通关无直接关系。 
en-us	Such certificate represents a service instead of a license and is not directly related to the customs clearance of goods. 

zh-cn	为规范医疗器械出口销售证明的出具行为，
en-us	In order to regulate the issuance of Certificates of Free Sale for medical devices, 

zh-cn	2015年6月，国家药品监督管理部门发布了《医疗器械产品出口销售证明管理规定》，
en-us	in June 2015, the state drug administration authorities issued the Regulations on the Administration of Certificate of Free Sale for Medical Devices and Products, 

zh-cn	规定在我国已取得医疗器械产品注册证书及生产许可证书，
en-us	which stipulates that when manufacturing enterprises have obtained registration certificates and manufacturing licenses for their medical devices and products 

zh-cn	或已办理医疗器械产品备案及生产备案的，
en-us	or when the medical devices and products and the act of production have been registered in China, 

zh-cn	药品监管部门可为相关生产企业出具《医疗器械产品出口销售证明》。
en-us	the medical product regulatory authorities may issue Certificates of Free Sale for medical devices and products for such enterprises. 

zh-cn	同时明确，企业应当保证所出口产品符合医疗器械出口相关规定要求，并应当符合进口国的相关要求。 
en-us	It is also provided that enterprises should ensure that the medical devices they export meet the requirements of the relevant regulations on the export of medical devices and the requirements of the importing country or region. 

zh-cn	出口医疗器械的生产企业可向本行政区省级药品监管部门或其指定的部门提交
en-us	Manufacturers of exported medical devices could submit the following documents to the provincial medical product administration departments or their designated departments of the administrative region where they are located :

zh-cn	《医疗器械产品出口销售证明登记表》
en-us	the registration forms for Certificates of Free Sale for medical devices and products, 

zh-cn	和企业营业执照、医疗器械生产许可证或者备案凭证、医疗器械产品注册证或者备案凭证的复印件等资料，
en-us	the original or copies of the business license of the company, licenses or registration certificates for the production of medical devices, and registration certificates or record of medical devices, and other information.

zh-cn	办理《医疗器械产品出口销售证明》。 
en-us	to apply for Certificates of Free Sale for medical devices and products

zh-cn	联合公告中明确，
en-us	The Joint Notice made it clear that 

zh-cn	海关凭药品监管部门批准的医疗器械产品注册证书验放。
en-us	the customs will inspect and release the goods based on the registration certificates for medical devices and products approved by the medical product supervision and administration department. 

zh-cn	公告发布后，如果企业提出需求，药品监管部门还将继续为企业出具《医疗器械产品出口销售证明》，做好相关服务。
en-us	After the publication of the Notice, the medical product regulatory authorities may issue Certificates of Free Sale for medical devices and products for enterprises upon request and offer relevant services. 

zh-cn	依据《医疗器械产品出口销售证明管理规定》，
en-us	based on the Regulations on the Administration of Certificate of Free Sale for Medical Devices and Products,

zh-cn	这里再次强调，三部门联合公告中规定，
en-us	Here we want to stress once again that the Joint Notice of the three departments provides that 

zh-cn	海关凭药品监管部门批准的医疗器械产品注册证书验放，
en-us	the customs will inspect and release the goods based on the registration certificates for medical devices and products approved by the medical product supervision and administration department, 

zh-cn	而不是根据出口销售证明验放。
en-us	rather than on the basis of Certificates of Free Sale.