The US FDA allows the import of Chinese KN95 masks again

According to the real-time statistics system of global COVID-19 data released by Johns Hopkins University in the United States, as of 6 p.m. Eastern Time on April 2, a total of 240,000 confirmed cases of COVID-19, 5,758 deaths, and 8,889 cured cases were reported in the United States. In the past 24 hours, more than 30,000 new cases were confirmed and 1,001 new deaths were reported.

The epidemic in the United States is becoming more and more serious. Now is the time when the American people are in urgent need of masks and other epidemic prevention materials. Masks have therefore become a hot product in the cross-border e-commerce circle. No matter whether they are big sellers or small sellers, they are all eyeing this piece of fat and want to get a piece of the pie.

However, the topic surrounding mask exports to the United States is always unpredictable. On March 28, according to the guidance issued by the US FDA, China's N95 masks are no longer allowed to be used in the United States.

Not long after, the United States changed its mind again! According to foreign media reports, a senior FDA official said on Thursday that the agency would not block the import of KN95 masks to help alleviate the shortage of personal protective equipment in the United States.

Screenshot from Sina Weibo

Why did the United States slap its face so quickly? Because they were running out of medical supplies!

US President Trump confirmed at a White House press conference that the federal government's stockpile of medical supplies is running low. According to CCTV News, US media previously reported that the US federal government's stockpile of medical supplies such as masks and gloves is almost exhausted, and states are still seeking assistance from the federal government. Due to the shortage of supplies, the federal government has to compete with state governments and private companies for resources in the global market.

Screenshot from Sina Weibo

The U.S. federal government is in such short supply of masks that Amazon announced in the early morning of April 3rd, Beijing time, that it would prioritize delivering essential supplies to hospitals, government agencies, and other groups during the coronavirus outbreak, and would stop providing N95 masks to the American public.

An Amazon spokesperson said the company is no longer allowing sellers to sell certain coronavirus-related supplies in its stores to ensure hospitals and government organizations have access to scarce medical supplies during the pandemic.

The spokesperson said that in addition to N95 masks and similar masks, Amazon will limit public access to coronavirus diagnostic kits and will monitor other product categories to determine whether they should be prioritized for sale to hospitals and government organizations. Other supplies such as small-volume disinfectants and wipes for personal use will still be sold to the public.

Amazon has also launched a section for COVID-19 prevention supplies, where any accredited hospital or federal and state government agency in the United States can order medical necessities such as N95 masks, surgical masks, protective masks, surgical gowns, surgical gloves, and large-volume disinfectants .

Amazon also claimed that they would not make any profit from this and would waive commissions on the platform for sellers selling these products for three months.

This is a great benefit for sellers with relevant qualifications. If sellers meet the qualifications for exporting to the United States and have the conditions to provide large quantities of epidemic prevention materials, they can click this link http://www.amazon.com/COVID-19-Supplies, then click "Contact us", follow the steps to submit relevant information, and Amazon will then review the seller's request.

It is reported that Amazon has listed a total of more than 1,700 ASINs that can participate in this government procurement plan. There are 244 ASINs for masks, and the rest are other epidemic prevention materials such as gloves, protective clothing and disinfectants. The specific ASIN sellers can check in the link above.

We all know that masks exported to the EU need to have CE certification. Currently, the newly completed CE certificates for medical masks on the market are basically issued based on the EU Medical Device Directive MDD 93/42/EEC.

However, there is a potential crisis: the CE certificates of some masks on the market may have to be replaced in more than a month.

On May 5, 2017, the European Union issued the new version of the Medical Device Regulation MDR (EU 2017/745). On May 25, 2017, the MDR officially came into effect.

The transition period between the old Medical Device Directive, MDD (93/42/EEC) and the new MDR (EU 2017/745) is three years.

That is to say, from May 26, 2020, the MDR directive will be enforced in the EU, and it will completely replace the old Medical Device Directive MDD (93/42/EEC) and the old Active Implantable Medical Device Directive AIMDD (90/385/EEC).

It is important to point out that:

After the MDR is enforced, new CE certification applications must be implemented in accordance with the MDR;

Products that currently do not have a CE certificate must be certified in accordance with the MDR from May 27;

MDD certificates issued before May 26, 2020 can still be used within the validity period, at the latest until May 26, 2024; the original MDD certificates must be replaced with MDR before the certificates expire.

New rules for the export of medical supplies. Recently, the Ministry of Commerce, the General Administration of Customs, and the State Food and Drug Administration jointly issued an announcement: From April 1, enterprises exporting new coronavirus testing reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers must provide written or electronic declarations when declaring to the customs.

It can be seen that my country is gradually increasing its efforts to strictly control the quality of exported medical supplies, standardize export order, and crack down on counterfeit and shoddy products.

As China increases its inspection efforts on the export of medical supplies such as masks, it will become increasingly difficult for cross-border e-commerce sellers to export masks. Some sellers advise that sellers who are not qualified enough and do not have sufficient funds should not touch this easily, as the money earned may not be returned.

For these sellers, it is better to manage their existing categories well and continue to optimize the listings that need to be optimized. When the epidemic is over and the market recovers, there will definitely be a rebound in demand, and then you will be the ones laughing.

Source: Seller Growth Academy