Recently, New Regulations Have Emerged Frequently For The Export Of Masks! China And The United States Have Undergone Important Changes!

In recent days, the news about anti epidemic materials such as masks in the United States and China has kept on, and many foreign traders feel confused. Today, we will sort it out from the United States and China respectively.

U.S.A

Hot spot 1: CDC lists the latest 100+Chinese mask enterprises' test results

On May 12, the US Centers for Disease Control and Prevention (CDC) released an announcement titled NPPTL Respirator Assessments to Support the COVID-19 Response on the test results of Chinese masks.

The announcement lists more than 100 Chinese mask enterprises, including enterprise name, product type, executive standards and test results, among which there are some problematic products, and it is recommended that exporters pay special attention to them.

The following is a partial screenshot of the test results of the US CDC on Chinese masks:

Specific inquiry website:

https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

Hot spot 2: FDA removes non NIOSH certified masks in large quantities

On May 7, the US FDA updated the EUA authorization document for the NIOSH certified respirators manufactured in China, and only 14 manufacturers of non NIOSH certified respirators manufactured in China were approved by the FDA.

Compared with the list of approved enterprises previously released, the list of approved enterprises released this time has not increased but decreased, and has been significantly reduced. The US FDA said that the masks produced by these removed manufacturers could not provide adequate protection against COVID-19.

According to the announcement of the China Chamber of Commerce for the Import and Export of Medicines and Health Products on May 1, there are 45 non medical mask manufacturers that have obtained the US EUA access, which is in contradiction with the 14 Chinese mask manufacturers issued by the US FDA on May 7.

That is to say, at least 31 non medical mask manufacturers have been removed from the EUA list by the US FDA although they have been included in the Chinese export white list! (Focus!)

Can these enterprises still export to the United States normally? It is recommended that the foreign party keep close communication.

The following is the list of respirator enterprises in the US FDA Emergency Use Authorization (EUA) Chinese standard:

Specific inquiry website:

https://www.fda.gov/media/136663/download

domestic

Hot spot 1: The General Administration of Customs announces the list of 16 enterprises that export unqualified epidemic prevention materials

On May 9, the General Administration of Customs released the batch list of unqualified quality and safety of exported epidemic prevention materials recently found by the national customs, naming 16 export enterprises and their related production enterprises.

Website of 16 unqualified enterprises:

www.customs.gov.cn//customs/xwfb34/302425/3044771/index.html

The General Administration said that in order to deepen international cooperation in epidemic prevention and control and jointly respond to the global public health crisis during the special period of the continued spread of the global epidemic, the customs will impose administrative penalties in accordance with the law on the anti epidemic materials found in the export link that are mouldy, damaged, contaminated, beyond the shelf life and unqualified in the quality and safety projects tested by the laboratory.

In addition to transferring those who meet the criteria for criminal filing to the judicial authorities for criminal accountability, they will also take various disciplinary measures such as downgrading credit ratings, increasing the proportion of inspections, suspending or canceling relevant qualifications in accordance with the law, and exposing information about violations of laws and regulations, so as to make them "dishonest and limited".

Hotspot 2: The national moratorium on the export of six types of epidemic prevention materials such as masks through market procurement trade and answers to hot issues

On the same day, Yiwu Municipal Bureau of Commerce issued the Notice on Suspending the Market Procurement and Export of Certain Epidemic Prevention Materials.

Specific inquiry website:

http://trade.yw.gov.cn/ptgg/t9698.html

The circular said that from May 10, the export of new coronavirus detection reagents, medical masks, medical protective clothing, respirators, infrared thermometers and other medical materials and non medical masks will be suspended nationwide through market procurement trade.

At the same time, the official micro blog of Yiwu Municipal Bureau of Commerce released the "Answers to Hot Issues on Exporting Anti epidemic Materials".

Hot issues include:

1. Can epidemic prevention materials not be exported through market procurement trade?

A: Since May 10, the export of new coronavirus detection reagents, medical masks, medical protective clothing, respirators, infrared thermometers and other medical materials and non medical masks (referred to as 5+1 epidemic prevention materials) through market procurement trade has been suspended nationwide. Not all epidemic prevention materials can be exported through market procurement trade.

2. Are the 5+1 epidemic prevention materials not allowed to be declared for export in Yiwu?

A: It can be exported in Yiwu in the form of general trade (commonly known as "3% levy and 3% rebate" general trade can also be used). Customs declaration consultation hotline: Xinhai Customs declaration itinerary is 13506890402.

3. Is it true that only white listed enterprises of the Ministry of Commerce can export five categories of medical materials and non medical masks?

A: If five categories of medical materials are exported according to China's quality standards, the registration certificate of medical devices approved by the drug regulatory authorities should be provided (the registration information of relevant medical devices in China is dynamically updated on the website of the State Food and Drug Administration at www.nmpa.gov.cn); If exporting according to foreign quality standards, the manufacturing enterprises shall be those listed in the list of manufacturing enterprises that have obtained certification or registration of foreign standards published by the Medical Insurance Chamber of Commerce (i.e. "white list enterprises of the Ministry of Commerce"). In both cases, the declaration of exported medical materials shall be submitted at the time of customs declaration.

If the non-medical masks are exported according to Chinese quality standards, they need not be included in the list of non-medical masks and enterprises with substandard quality investigated and dealt with in the domestic market provided by the Market Supervision Administration (dynamic update on the website of the Market Supervision Administration www.samr.gov.cn); If exporting according to foreign quality standards, the manufacturing enterprises shall be those listed in the list of manufacturing enterprises that have obtained certification or registration of foreign standards published by the Medical Insurance Chamber of Commerce (i.e. "white list enterprises of the Ministry of Commerce"). In both cases, an electronic or written declaration jointly made by the exporter and importer must be submitted at the time of customs declaration to confirm that the products meet Chinese quality standards or foreign quality standards, and the importer accepts the quality standards of the purchased products and is not used for medical purposes.

Hotspot 3: What are the latest white list enterprises?

On May 12, the official website of China Chamber of Commerce for the Import and Export of Medicines and Health Products again updated the list of medical material manufacturers that have obtained foreign standard certification or registration and the list of non medical mask manufacturers that have obtained foreign standard certification or registration.

List of medical material manufacturers certified or registered by foreign standards

Specific inquiry website:

www.cccmhpie.org.cn/Pub/6325/176237.shtml

List of non medical mask manufacturers that have obtained foreign standard certification or registration

Specific inquiry website:

www.cccmhpie.org.cn/Pub/6325/176233.shtml

Hot spot 4: re upgrading of supervision

On May 13, seven departments, including the General Administration of Market Supervision, issued the Notice on the Action Plan for Special Rectification of the Quality and Market Order of National Anti epidemic Materials, which pointed out that the supervision of five categories of anti epidemic materials and their important raw and auxiliary materials, including masks, protective clothing, respirators, infrared thermometers (forehead temperature guns), and new coronavirus detection reagents, should be strengthened, Ensure the smooth operation of the whole industrial chain of epidemic prevention materials.

Specific inquiry website:

gkml.samr.gov.cn/nsjg/jjjzj/202005/t20200513_315167.html