Foreign Trade Information: There Have Been Major Changes In Export Of Masks And Other Anti Epidemic Materials.

As of 05:58 data on the morning of April 1st in Beijing, the number of confirmed cases of new crown pneumonia in the world has exceeded 850 thousand, and 42014 cases have died. 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 and other countries or regions all give tariff relief or customs clearance to related products. For details, please see: the export of anti epidemic materials! Export to these countries for 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.

01, the US refused to import China KN95 mask.

In March 17th, the United States Centers for Disease Control and Prevention (CDC) released the "optimized N95 mask supply strategy: Crisis / replacement strategy", pointing out that when the N95 mask was not supplied enough, the masks manufactured in Brazil, Korea, Japan, Australia, the European Union, Mexico and China were suitable substitutes for N95 masks, including the adoption of the Chinese standard GB. 2626-2006, GB/T 18664-2002 produces KN100, KP100, KN95 and KP95 masks.

But in the United States, when the number of confirmed cases increased wildly, in March 28th, the US FDA also issued a "tight management" letter (Emergency-Use-Administration, referred to as EUA) for manufacturers, health care workers, hospital purchasing departments, distributors, importers and commercial wholesalers who did not meet the NIOSH standard.

According to the new scope of authorization, only Australia, Brazil, the European Union, Japan, Korea and Mexico meet the requirements of six countries and regions, 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.

Imported-Non-NIOSH-letter.pdf (click 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 version of today's headline BuzzFeed reported that "if there is no FDA approval, 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 is easier to buy KN95 mask now, N95 is hard to buy. 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.

02, 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 that the federal health authorities would no longer distribute the rescue equipment before making sure that the masks provided by China were in conformity with the quality standards, 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."

03, Holland and Spain find product quality problems

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. However, after two tests, the masks failed to touch the face and filter the virus. 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 more than 80%, but the kit is only 30%.

In response, the Chinese Embassy in Spain responded that the kit provider was a Shenzhen company and was not listed in the list of medical equipment sales companies provided by China's Ministry of Commerce, and has not yet obtained the sales license of the State Administration of drugs.

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 imported 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.

04, April export declaration of medical supplies

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:

? ? "From April 1st onwards, enterprises exporting new coronavirus test reagents, medical masks, medical protective clothing, respirators and infrared thermometers shall submit written or electronic statements to the customs when they declare to the Customs (template 1, annex). They promise that the export products have obtained the registration certificate of medical device products in China (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.

Announcement address (click picture)

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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 that it is necessary to properly supervise the quality control of export drugs, strictly regulate the management of drug export certification, and resolutely withdraw the certificate of drug export in accordance with the requirements of failing to comply with the conditions and requirements of the certification and failing to comply with the GMP of our country's drugs. We should strengthen coordination with market supervision, customs and public security departments to crack down on illegal activities.

The meeting called for drug supervision departments at all levels to intensify the investigation and handling of illegal cases and strictly investigate and punish illegal activities in accordance with the "four most stringent" requirements. 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.

05, be alert to the risk of medical device export.

Foreign trade workers must pay attention to the legal risks of the recent export of medical devices. The shortage of supply 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:

1. understand the access standards and certification status of medical device products in various export markets, and keep these information updated.

2., pay attention to the authenticity and effectiveness of certification, strictly examine the qualification of agent intermediaries, and do not choose those agents who are significantly lower than the normal price.

3. strictly carry out production according to the standards, and ensure the legal compliance of their products.

4. when the tide ebb knows the naked swimmer, it is prudent to look at the "mask bonus period".