关于12号公告回应的热点问题Hot issues regarding the response to Announcement 12

发布时间：

2020-05-09

关于12号公告回应的热点问题1.对4月26日前签订的非医用口罩出口合同，生产厂商是否需要列入医保商会公布的取得国外标准认证或注册的非医用口罩生产企业清单中？答：不用。4月26日前签订的非医用口罩出口合同按公告发布之前的方式执行，生产企业不必在医保商会公布的取得国外标准认证或注册的非医用口罩生产企业清单内，但出口企业应当在报关时提交电子或书面的出口方和进口方共同声明。2.针对新型冠状病毒检测试剂、医

关于12号公告回应的热点问题

1.对4月26日前签订的非医用口罩出口合同，生产厂商是否需要列入医保商会公布的取得国外标准认证或注册的非医用口罩生产企业清单中？

答：不用。4月26日前签订的非医用口罩出口合同按公告发布之前的方式执行，生产企业不必在医保商会公布的取得国外标准认证或注册的非医用口罩生产企业清单内，但出口企业应当在报关时提交电子或书面的出口方和进口方共同声明。

2.针对新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计等5类医疗物资产品出口，12号公告出台后，5号公告是否继续执行？

答：5号公告继续执行。12号公告是对5号公告的进一步完善和优化，两个公告同步执行。即如果5类医疗物资产品按中国质量标准出口，需提供药品监督管理部门批准的医疗器械产品注册证书；如按国外质量标准出口，生产企业应为医保商会公布的取得国外标准认证或注册的生产企业清单中的企业。

3.企业如何进入医保商会公布的取得国外标准认证或注册的防疫物资生产企业清单中？

答：商务部已就此问题于4月25日专门下发《关于组织做好审核确认符合国外标准认证或注册的防疫物资生产企业名单有关工作的通知》，要求地方商务主管部门组织做好自愿申报和审核确认工作。该通知已在商务部网站公开发布。

（http://wms.mofcom.gov.cn/article/zcfb/g/202004/20200402959046.shtml）

4.对4月26日之后签订的非医用口罩出口合同，生产企业没进入医保商会公布的取得国外标准认证或注册的非医用口罩生产企业清单中，能否出口？

答：首先企业应明确出口的产品是符合中国标准还是国外标准。如果出口方和进口方约定产品按国外标准出口，生产企业应当列入医保商会公布的取得国外标准认证或注册的非医用口罩生产企业清单中。如果出口方和进口方约定产品不是按国外标准出口，且生产企业不在市场监管总局提供的国内市场查处的非医用口罩质量不合格产品和企业清单内，在企业提交共同声明的情况下，相关产品可以出口。

5.医疗物资生产企业没有国内医疗器械产品注册证书，有国外的CE、FDA证书（在医保商会公布的企业名单中），但出口国没有对应证书，采购商合同和相关协议已约定接受国外质量标准，出口如何处理？

答：只要双方约定接受国外标准即可。相关标准不一定是进口国（地区）的质量标准。

Hot issues regarding the response to Announcement 12

1. For non-medical mask export contracts signed before April 26, does the manufacturer need to be included in the list of non-medical mask manufacturers that have obtained foreign standard certification or registration published by the Medical Insurance Association?

Answer: No. The export contract for non-medical masks signed before April 26 will be executed in the same manner as before the announcement. The manufacturer does not need to be listed in the list of non-medical mask manufacturers that have obtained foreign standard certification or registration issued by the Medical Insurance Association, but the export enterprise should submit it at customs The electronic and written exporter and importer jointly declare.

2. For the export of 5 types of medical materials such as new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers, etc., will announcement No. 5 continue to be implemented after the announcement of announcement No. 12?

Answer: Announcement 5 continues to be implemented. Announcement 12 is the further improvement and optimization of Announcement 5, and the two announcements are executed simultaneously. That is, if the 5 types of medical materials are exported in accordance with Chinese quality standards, a medical device product registration certificate approved by the drug supervision and administration department must be provided; if they are exported in accordance with foreign quality standards, the manufacturing enterprise should obtain the foreign standard certification or registered production announced by the Medical Insurance Association Enterprises in the enterprise list.

3. How can an enterprise enter the list of anti-epidemic materials manufacturers that have obtained certification or registration of foreign standards published by the Medical Insurance Association?

Answer: The Ministry of Commerce has specially issued the "Notice on Organizing the Work on the List of Enterprises for the Inspection and Confirmation of Conformity and Registration of Anti-epidemic Materials Produced in Accordance with Foreign Standards" on April 25, requesting local commercial authorities to organize voluntary declarations And review and confirmation work. The notice has been published on the website of the Ministry of Commerce.

(Http://wms.mofcom.gov.cn/article/zcfb/g/202004/20200402959046.shtml)

4. For non-medical mask export contracts signed after April 26, the manufacturing enterprises have not entered the list of non-medical mask manufacturing enterprises that have obtained foreign standard certification or registration published by the Medical Insurance Association, can they be exported?

Answer: First of all, enterprises should make clear whether the exported products comply with Chinese standards or foreign standards. If the exporter and the importer agree that the products are exported according to foreign standards, the manufacturing enterprise shall be included in the list of non-medical mask manufacturing enterprises that have obtained certification or registration of foreign standards published by the Medical Insurance Association. If the exporter and the importer agree that the product is not exported according to foreign standards, and the manufacturer is not included in the list of non-medical masks of unqualified products and enterprises listed in the domestic market provided by the General Administration of Market Supervision, the relevant products are submitted in the case of a joint declaration Can be exported.

5. Medical material manufacturing companies do not have domestic medical device product registration certificates, and have foreign CE and FDA certificates (in the list of companies published by the Medical Insurance Chamber of Commerce), but the exporting country does not have a corresponding certificate, and the buyer ’s contract and relevant agreements have agreed to accept foreign quality Standards, how to deal with exports?

Answer: As long as both parties agree to accept foreign standards. The relevant standard is not necessarily the quality standard of the importing country (region).

Keyword:

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重磅发布！《中华人民共和国出口管制法》表决通过！12月1日实施Heavy release! The "Export Control Law of the People's Republic of China" was voted through! Implemented on December 1

海关总署2020年第53号公告—医疗物资出口质量监管Announcement No. 53 of 2020 by the General Administration of Customs-Quality Supervision of Medical Materials Export

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关于12号公告回应的热点问题