Since April, There Have Been Major Changes In The Export Of Masks And Other Anti Epidemic Materials. The Unqualified Person Cancels The Export License.

As of Beijing time April 1st morning 05:58 data, There are more than 850 thousand confirmed cases of new crown pneumonia worldwide. There were 42014 deaths. The number of new crown pneumonia cases outside China is far more than that of new cases.

The pandemic of the epidemic has made masks and other anti epidemic products a single export product for the first quarter.

South Korea, Iran, Turkey, France, Malaysia, Thailand, Vietnam, Kyrgyzstan, Pakistan, Sri Lanka, Maldives, Brazil, Venezuela, Zimbabwe, Eurasian Economic Union Other countries or regions give tariff reduction or customs clearance to related products. For details, please see: Anti epidemic materials! Export to these countries about tax relief! )

After all, under the urgent situation of "hard to find", only China, which is gradually getting rid of the epidemic situation and resuming production, has the ability to meet the huge demand for medical materials.

But now there are new changes in the export of masks and other anti epidemic materials.

Us refuses to import China KN95 mask

In March 17th, the US Centers for Disease Control and Prevention (CDC) released the "optimized N95 mask supply strategy: Crisis / replacement strategy", pointing out that when the supply of N95 masks was insufficient during the outbreak of new crown pneumonia, Brazil, Korea, Japan, Australia, the European Union, Mexico, China's standard mask is a suitable substitute for N95 respirator. It includes KN100, KP100, KN95 and KP95 mask manufactured by China standard GB 2626-2006 and GB/T 18664-2002.

But in the case of a surge in the number of confirmed cases in the United States, in March 28th, the US FDA issued a new "emergency management letter" (Emergency-Use-Administration, referred to as EUA) for manufacturers of imported disposable filter masks, health care workers, hospital purchasing departments and distributors, importers and commercial wholesalers who did not meet the NIOSH standards.

According to the new scope of authorization, Only six countries and regions in Australia, Brazil, the European Union, Japan, Korea and Mexico meet their requirements and China is excluded.

This means that the mask of these six countries and regions can be exported to the United States if they meet the relevant standards of their own countries or regions and have obtained relevant certification. However, Chinese standard KN95 and other masks can not be achieved. They must reach NOISH standards and certification before they can be used in medical institutions in the United States.

The US announcement:

Www.fda.gov/media/136403/download

By the morning of April 1st Beijing, the United States reported 186265 confirmed cases of new crown pneumonia, with the highest number of confirmed cases in the world.

"When hospitals across the United States are desperately looking for N95 masks to protect healthcare workers from treating new crown pneumonia, the US federal government has banned imports as the world's most abundant substitutes." The US Edition of today's headline BuzzFeed reported that "Without the approval of FDA, the importers hesitate to order KN95 masks because they are worried that they will be detained by customs. Many hospitals refuse to accept these donations, even if they are free, because they are concerned that if medical personnel are sick when using unlicensed equipment, they will be held liable. "

American importer Bob Tilden said. "It's easier to buy KN95 masks now, and N95 is hard to get. But I don't want to risk losing 500 thousand or 1 million dollars for the masks. "

President Trump appealed to the American people to "wear scarves" instead of masks.

Canada will evaluate medical products in China

After receiving the rescue equipment from China, the Canadian government stopped distributing the equipment to the major hospitals. In a statement to the Canadian News Agency, the Canadian Ministry of Health said: "part of the cargo has been delivered to the relevant medical service institutions. The "mask part" of the goods was shelved and no further distribution was received for assessment.

On March 29th, Canadian Prime Minister Justin Trudeau promised at a news conference. Before ensuring that the masks provided by China are up to the quality standards, the federal health authorities will no longer distribute the rescue equipment and spare no effort to investigate the quality of the respirators.

Trudeau said: "I can assure people that the Canadian Ministry of health has very strict procedures to assess the materials we receive meet the required standards and there will be no shortcuts." "We need to ensure that the supplies and equipment that medical personnel rely on are safe to ensure that they can achieve the quality of their work and ensure their safety."

Quality problems found in Holland and Spain

In March 28th, the Ministry of health of Holland issued a statement that 21 Chinese masks with "KN95" rating were received on the 1 million 300 thousand day, but two tests were conducted. It was found that the mask was not able to attach to the face and filter virus function failed. The first 600 thousand masks have been distributed to hospitals for medical care. The authorities ordered all of them to be recovered and the masks ordered from China will be tested more rigorously.

According to reports from the Spanish media, "state newspaper" and "Le Monde" and other media reports, Spain's purchase of a new crown virus rapid test kit from China is not accurate. The accuracy of the kit should be over 80%, but the kit is only 30%.

In response, the Chinese Embassy in Spain responded that the kit provider was an enterprise in Shenzhen. It is not in the list of medical equipment sales companies provided by China's Ministry of Commerce. The sales license of the China National Drug Administration has not yet been obtained.

In a subsequent statement, the Spanish government said that the defective kit was not purchased directly from the Chinese government by the Spanish government, but rather by the Spanish government. Import from a Chinese supplier through a domestic supplier. Spain has immediately returned the kit and contacted suppliers to request alternative kits.

The company in Shenzhen issued a statement of explanation: it is understood that during the process of sampling and sample extraction, samples of nasopharyngeal swabs were not strictly sampled, extracted and operated according to their operation instructions, resulting in a decrease in accuracy of sample detection.

At present, the Shenzhen municipal market supervision and Administration Bureau has launched a quick verification, and the concrete situation will be kept informed.

Declaration of medical supplies exports from April

On the evening of March 31st, the Ministry of Commerce, the General Administration of customs and the State Administration of pharmaceuticals issued an urgent notice - "the announcement on orderly export of medical materials" (No. fifth 2020).  

The announcement said:

"Since April 1st, when exporting new coronavirus reagents, medical masks, medical protective clothing, respirators and infrared thermometers to customs, Written or electronic statement is required (template 1). The registered products of China's medical devices have been obtained. The relevant registration information is shown in Annex 2, which is in conformity with the quality standard requirements of the importing countries (regions). The customs shall examine and release the medical device product registration certificate approved by the drug supervision and administration department. The quality control measures for the export of medical materials will be dynamically adjusted according to the epidemic situation.

Notice address:

Http://www.mofcom.gov.cn/article/b/c/202003/20200302950371.shtml? From=groupmessage&isappinstalled=0

Here we can download the "export medical materials declaration template" and "China's related medical device product registration information (www.nmpa.gov.cn updated by the SFDA website").

In addition, on the afternoon of March 31st, the drug supervision department of the State Administration of Drug Administration convened a video conference on key tasks of post marketing supervision in 2020. The contents of the conference deserve your attention.

The meeting stressed the need to properly supervise the quality control of export drugs. Strictly regulate the management of drug export certification. If we fail to comply with the conditions and requirements of the certificate and do not comply with the situation of GMP in China, we will resolutely withdraw the certificate of drug export according to law. We should continue to strengthen drug production supervision and ensure that the quality of export medicines meets the requirements. We should strengthen coordination with market supervision, customs and public security departments to crack down on illegal activities.

The meeting called for all levels of drug supervision departments to intensify efforts to investigate illegal cases. In accordance with the "four most stringent" requirements, we must seriously investigate and punish illegal activities. According to the actual situation, we should make full use of the means of property punishment, qualification penalty, free punishment, reputation punishment and other means to effectively punish enterprises and punish them. We should also make full use of measures such as warning, interviews, deadline rectification and other measures. We should take corresponding control measures to suspend production, sale, use and importation according to risks for quality problems or other hidden dangers, and control risks in time. All localities should strengthen coordination with the comprehensive law enforcement agencies of market supervision, accelerate the establishment of effective linkage mechanism between supervision and inspection, deepen communication and coordination with public security organs, strengthen the connection of execution, and form joint efforts in investigating cases. In view of the risk prone links or areas, the State Administration of drug administration will deploy special rectification to further regulate production and operation through remediation, seriously investigate and expose illegal behaviors and create a strong deterrent effect.

Watch out for export risks of medical device products

Foreign trade workers must pay attention to the legal risks of the recent export of medical devices. Supply shortage does not mean that buyers can accept unqualified products, and do not blindly enter the market because of the hot market.

The exporter is advised to: