In recent days, there have been constant news in the United States and China about masks and other anti-epidemic materials, and many foreign traders feel confused. Today we will sort it out from the United States and China respectively.
United States
Hot spot 1: CDC lists the latest test results of 100+ Chinese mask companies
On May 12, the U.S. Centers for Disease Control and Prevention (CDC) issued an announcement titled “NPPTL Respirator Assessments to Support the COVID-19 Response” regarding the test results of Chinese masks. The announcement lists 100+ Chinese mask companies, including company names, product types, implementation standards and test results, etc. There are some problematic products among them, and exporters are recommended to pay special attention.
The following is a partial screenshot of the US CDC’s test results on Chinese masks:
Specific query Website: cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html
Hot Spot 2: FDA removes non-NIOSH certified masks in large quantities
On May 7, the U.S. FDA updated the EUA authorization documents for masks produced in China that have not been NIOSH certified. There are only 14 manufacturers of non-NIOSH certified masks produced in China that have been approved by the FDA.
Compared with the previously released list of approved companies, the list of approved companies released this time has not increased but decreased, and has been significantly deleted. The US FDA stated that the masks produced by these removed manufacturers did not provide adequate protection against the new coronavirus.
According to the China Chamber of Commerce for Import and Export of Medicines and Health Products announced on May 1, there are 45 non-medical mask manufacturers that have obtained EUA access to the United States. This is in line with the announcement by the US FDA on May 7. EUA 14 Chinese mask companies have conflicts. In other words, at least 31 non-medical mask manufacturers have been removed from the EUA list by the US FDA although they are included in China’s export whitelist! (Emphasis added!)
Can these companies still export to the United States normally? It is recommended that foreign parties maintain close communication.
The following is the list of Chinese standard mask companies with US FDA Emergency Use Authorization (EUA):
Specific inquiry website: fda.gov/media/136663/download
Domestic
Hot spot one: General Customs The General Administration of Customs announced a list of 16 companies that failed to export epidemic prevention materials
On May 9, the General Administration of Customs announced a list of batches of exported epidemic prevention materials that had recently been found to be unqualified for quality and safety by customs across the country. Named 16 export companies and related production companies.
16 unqualified enterprises query website: customs.gov//customs/xwfb34/302425/3044771/index.html
The General Administration stated that during the special period when the global epidemic continues to spread, in order to deepen international cooperation in epidemic prevention and control and jointly respond to the global public health crisis, the Ministry of Foreign Affairs and Trade will issue orders for moldy, damaged, and damaged goods seized during the export process. For anti-epidemic materials that are contaminated, exceed the shelf life, and fail to pass laboratory testing for quality and safety items, the customs will impose administrative penalties in accordance with the law. In addition to transferring criminal cases to the judicial authorities for investigation of criminal responsibility, a variety of punitive measures will also be taken, such as lowering credit ratings, increasing the inspection ratio, suspending or canceling relevant qualifications in accordance with the law, and exposing illegal and illegal information, so that they will be “untrustworthy everywhere.” Restricted”.
Hot Topic 2: The nationwide suspension of the export of 6 types of anti-epidemic materials such as masks through market procurement and trade and answers to hot questions
On the same day, the Yiwu Municipal Commerce Bureau The “Notice on Suspension of Market Purchase and Export of Specific Epidemic Prevention Materials” was issued.
Specific query URL: trade.yw.gov/ptgg/t9698.html
The notice stated that starting from May 10, the nationwide export of new coronavirus testing reagents, medical masks, medical protective clothing, ventilators, infrared thermometers and other medical supplies and non-medical masks through market procurement and trade will be suspended. At the same time, the official Weibo account of the Yiwu Municipal Bureau of Commerce released “Answers to Hot Questions on the Export of Epidemic Prevention Materials.”
Hot issues include:
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1
Can’t epidemic prevention materials be exported through market procurement and trade?
A: Starting from May 10, the export of new coronavirus testing reagents, medical masks, medical protective clothing, ventilators, infrared thermometers and other medical supplies through market procurement and trade will be suspended nationwide. and non-medical masks (referred to as Category 5+1 epidemic prevention materials). Not all epidemic prevention materials cannot be exported through market procurement and trade.
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2
Are the 5+1 types of anti-epidemic materials not allowed to be declared for export in Yiwu?
Answer: You can export through general trade in Yiwu (commonly known as “3% tax and 3% refund” general trade is also possible). Customs declaration consultation phone number: Mr. Cheng of Xinhai Customs Service: 13506890402.
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3
Are only companies on the Ministry of Commerce’s white list allowed to export Category 5 medical supplies and non-medical masks?
Answer: If the 5 categories of medical supplies are exported according to Chinese quality standards, a medical device product registration certificate approved by the drug regulatory department must be provided (my country’s relevant medical device product registration information is in Dynamically updated on the website nmpa.gov of the State Food and Drug Administration); if exporting according to foreign quality standards, the manufacturing enterprise should be an enterprise in the list of manufacturing enterprises that have obtained foreign standard certification or registration published by the Medical Insurance Chamber of Commerce (i.e., the “Ministry of Commerce White List Enterprise”) . In both cases, a declaration of export medical supplies must be submitted during customs declaration.
If non-medical masks are exported according to Chinese quality standards, they must not be included in the list of non-medical masks with substandard quality and companies investigated and dealt with in the domestic market provided by the State Administration for Market Regulation (SAMR website samr .gov dynamic updates); if exporting according to foreign quality standards, the manufacturing enterprise should be an enterprise in the list of manufacturing enterprises that have obtained foreign standard certification or registration published by the Medical Insurance Chamber of Commerce (i.e., the “Ministry of Commerce White List Enterprises”). In both cases, an electronic or written joint statement from the exporter and importer must be submitted during customs declaration, confirming that the product meets Chinese quality standards or foreign quality standards, and that the importer accepts the quality standards of the purchased product and is not used for medical purposes.
Hot Topic 3: What are the latest whitelist companies?
The official website of the China Chamber of Commerce for Import and Export of Medicines and Health Products updated again on May 12 the list of medical material manufacturers that have obtained foreign standard certification or registration and the list of non-medical masks that have obtained foreign standard certification or registration. List of manufacturing companies.
List of medical material manufacturers that have obtained foreign standard certification or registration
Specific query website: cccmhpie/Pub/6325/176237.shtml
List of non-medical mask manufacturers that have obtained foreign standard certification or registration
Specific query URL: cccmhpie/Pub/6325/176233.shtml
Hot spot four: Upgrading supervision
On May 13, seven departments including the State Administration for Market Regulation issued a notice on the “National Special Rectification Action Plan for Anti-epidemic Materials Product Quality and Market Order”. The notice pointed out that the focus was on masks, protective clothing, ventilators, and infrared thermometers (amount of Temperature guns), new coronavirus detection reagents and other five categories of epidemic prevention materials and their important raw and auxiliary materials have been strengthened to ensure the smooth operation of the entire industry chain of epidemic prevention materials.
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