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"Tightening" the Export of Anti-epidemic Materials? We Have All These Qualifications!

"Tightening" the Export of Anti-epidemic Materials? We Have All These Qualifications!

Word:[Big][Middle][Small] QR Code 2018-10-26     Viewed:    
一切的设计需要是在功能合理的基础上进行视觉美化

Recently, Chinese Ministry of Foreign Affairs spokesperson Hua Chunying responded that "KN95 masks are Chinese substitutes for N95 masks, but the US Food and Drug Administration has not allowed such masks to enter the United States." at a regular press conference.


Under the current epidemic situation, masks are urgently needed by countries, and China's domestic demand is also great. Chinese enterprises are working overtime day and night at full capacity. In order to meet domestic demand while at the same time They try to provide security for other countries to prevent and control the epidemic. Indeed, the supply of anti-epidemic materials also involves specific issues such as differences in certification standards for products in different countries and regions. But these issues should not be an obstacle in the fight against the epidemic.


Just on March 31, the Ministry of Commerce, the General Administration of Customs, and the State Drug Administration jointly issued an announcement:


Since April 1st, enterprises exporting new corona-virus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic declarations when they declare to the customs, commitment that export products have obtained China's medical device product registration certificate, while at the same time comply with the quality standards of the importing country (region).


At the same time, it is emphasized that we should supervise the quality of export drugs properly and standardize the administration of drug export certificates strictly. In the case of non-compliance with the conditions and requirements for issuing certificates and non-compliance with China's drug GMP, the drug export certificates shall be revoked according to the law. It is necessary to continue to strengthen the supervision of drug production and to ensure that the quality of exported drugs meet the requirements. It is necessary to strengthen the coordination with market supervision, customs, public security and other departments to crack down on violations of law and regulations.



At present, the global epidemic is accelerating and spreading. How can China's relevant epidemic prevention materials contribute to the global anti-epidemic? What the relevant state departments have to do is to ensure product quality and standardize the export order. At this point in time, the announcement jointly issued by the relevant departments is very meaningful.



Editor in particular reminds: To continue to do export business, you must put the product in domestic legal and regulatory registration listing, the product should meet the relevant domestic standards for medical devices.



Back to 2003, during the SARS period, in the "Notice of the State Food and Drug Administration on the classification of medical disposable protective clothing and other products", medical disposable protective clothing, medical protective masks and medical surgical masks are classified as the second category of medical devices for management.



Article 30 of the "Regulations for the Supervision and Administration of Medical Devices" stipulates that those engaged in the operation of the second category of medical devices shall be filed by the operating enterprise with the food and drug supervision and administration department of the municipal people's government in the district where they are located and submitted relevant proof to meet the requirements for engaging in medical device operations.



If you need to sell online, you must file for online transactions in accordance with the "Administrative Measures for the Supervision and Administration of Medical Device Network Sales". Therefore, the operation and sale of medical masks for epidemic prevention needs to be filed with the relevant authorities. The sale of medical masks without appropriate qualifications is illegal and may be subject to administrative penalties or, in serious cases, criminal penalties.