李国杰（经理）：18202125732 直线：021-61062636
申报***新要求
根据***、***、******监督***2020年第5号《关于有序开展***物资出口的公告》，在疫情防控特殊时期，为有效支持***抗击疫情，保证产品质量安全、规范出口秩序，自4月1日起，出口新型冠状病毒检测***、***口罩、***防护服、呼吸机、红外体温计的企业向海关报关时，需提供书面或电子声明，承诺出口产品已取得我国***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***监督管理部门批准的***器械产品注册证书验放。
即，出口属于***器械管理的防疫物资，从4月1日起，企业需提供***明文件。出口其他防疫物资，海关无特殊资质要求。
疫情期间，欧美放宽了一些必要准入条件，但均为应急措施或应急建议，实质并未放松具体技术要求，且同时强调了市场抽查和处罚的后续监管力度。同时，建议和意见不具备任何***约束效力，仅供成员国和监管机构参考。因此，为防范和降低风险，我国企业仍需严格按照目的地***的技术要求和合规评定要求进行生产经营，建议完成相关认证后再行出口。
Latest requirements for declaration
The novel coron***irus reagents, medical masks, medical protective clothing, ventilator and infrared radiation were exported from April 1st to April 1st, according to the announcement of the Ministry of Commerce, the General Administration of customs and the State Administration of drug control fifth on the orderly export of medical materials. In the special period of epidemic prevention and control, in order to effectively support the global fight against epidemic situation, ensure product quality and safety, and standardize export order, new coron***irus detection reagent, medical mask, medical protective clothing, ventilator and infrared radiation were exported from April 1st. When declaring to the customs, the enterprise of thermometer shall provide a written or electronic statement, promising that the exported products h***e obtained the registration certificate of China's medical device products and meet the quality standard requirements of the importing country (region). The customs shall examine and release the medical devices with the registration certificate approved by the drug regulatory department.
That is to say, for the export of epidemic prevention materials under the management of medical devices, the enterprise shall provide qualification certificates from April 1. For the export of other epidemic prevention materials, the Customs has no special qualification requirements.
During the outbreak, Europe and the United States relaxed some necessary access conditi***, but all of them were emergency measures or emergency suggesti***, which did not relax the specific technical requirements in essence, and emphasized the follow-up supervision of market spot check and punishment. At the same time, the suggesti*** and opini*** h***e no legal binding effect and are only for the reference of Member States and regulators. Therefore, in order to prevent and reduce the risk, Chinese enterprises still need to strictly follow the technical requirements and compliance asses***ent requirements of the destination country for production and operation, and it is recommended to complete the relevant certification before export.
李国杰（经理）：18202125732 直线：021-61062636
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