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A common feature of the coronavirus pandemic is the N95 masks—more precisely, the urgent need for them. Part of the reason for the shortage of masks is that with the outbreak of the epidemic, China ’s supply is declining, while the US supply is limited. In some cases, some people hoard masks to protect themselves. Insufficient supply has put medical workers and others at risk, which may have a ripple effect on other people. What makes this problem even worse is that people are confused about importing them into the United States. The urgent problem that needs to be solved is: a better understanding of customs regulations and community support.
Since speed is the most important aspect in health care, it is essential to try to prevent stalls when shipping medical supplies from abroad. Ensuring that goods and importers are registered and approved by fda is the key to keeping things going.
N95 masks prescribed by FDA (unlike Niosh certified N95 masks, which are designed for construction or food workers) are considered to be medical equipment, specifically for the medical industry. This is what is needed to obtain the necessary approval. maskwholesales
Manufacturers of N95 masks (also known as personal protective equipment or PPEs) must register medical devices with the FDA before importing.
Those who import masks must be registered with the FDA.
If foreign manufacturers and products are not approved by the FDA, they need to contact CDC at CVSDBadmin@cdc.gov. Once the US Centers for Disease Control and Prevention approves the request, the US Food and Drug Administration (FDA) will add the device to the list of authorized respirators.
Please keep in mind that shipments may be greatly delayed if you do not comply with customs regulations. For example, if an unregistered medical device enters the United States without FDA approval, the US Customs will detain the product and force it to be destroyed or re-exported back to the country of origin. However, the FDA has established an emergency use permit for coronaviruses; the company also said it may consider expediting the assessment of changes in production location or pre-market submission to help ease supply pressure.
At the same time, in order to solve the shortage of N95 masks, manufacturers are increasing production, and officials are also trying to let people know that such masks should be reserved for medical personnel who care for patients with coronavirus. In addition, some companies, such as Flexport, are working in their communities to deliver personal protective equipment (PPE) and respirators to those who need them most.
Flexport.org is a project focused on delivering humanitarian relief supplies. Flexport is raising funds through a GoFundMe event called the "Front-line Responder Fund" to help transport medical equipment to hospitals and areas affected by shortages. Actor, former governor and bodybuilder Arnold Schwarzenegger recently donated $ 1 million to support this effort, he told Rolling Stone: "Our doctors, nurses and medical staff are the real heroes of this crisis … We now have the opportunity and the responsibility to provide them with personal protective equipment to keep them safe during the fight against this virus. ”
Through cooperation with MedShare and Project CURE, Flexport.org has helped non-profit organizations to ship more than 450,000 masks, work clothes, gloves and other personal protective equipment to the hardest hit areas in China, Africa, the United States and Italy. We will continue to support non-profit organizations and for-profit organizations to fight this virus by delivering materials to affected areas. https://www.maskwholesales.com
In order to ensure that the equipment can be delivered to the right person, Flexport has established a policy that PPE can only be shipped if the existing or potential customer can prove which hospital system or first-line emergency response organization can receive the equipment. . In view of the huge pressure of COVID-19 on the medical system, the demand for PPE by frontline emergency personnel and medical service providers has become more urgent.