申報最新要求

根據商務部、海關總署、國家藥品監督管理局2020年第5號《關于有序開展醫療物資出口的公告》，在疫情防控特殊時期，為有效支持全球抗擊疫情，保證產品質量安全、規范出口秩序，自4月1日起，出口新型冠狀病毒檢測試劑、醫用口罩、醫用防護服、呼吸機、紅外體溫計的企業向海關報關時，需提供書面或電子聲明，承諾出口產品已取得我國醫療器械產品注冊證書，符合進口國（地區）的質量標準要求。海關憑藥品監督管理部門批準的醫療器械產品注冊證書驗放。

即，出口屬于醫療器械管理的防疫物資，從4月1日起，企業需提供資質證明文件。出口其他防疫物資，海關無特殊資質要求。

疫情期間，歐美放寬了一些必要準入條件，但均為應急措施或應急建議，實質并未放松具體技術要求，且同時強調了市場抽查和處罰的后續監管力度。同時，建議和意見不具備任何法律約束效力，僅供成員國和監管機構參考。因此，為防范和降低風險，我國企業仍需嚴格按照目的地國家的技術要求和合規評定要求進行生產經營，建議完成相關認證后再行出口。

The novel coronavirus 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 b fight against epidemic situation, ensure product quality and safety, and standardize export order, new coronavirus 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 have 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 conditions, but all of them were emergency measures or emergency suggestions, 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 suggestions and opinions have 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 assessment requirements of the destination country for production and operation, and it is recommended to complete the relevant certification before export.

李國杰（經理） ：18202125732 

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