Company Helping to Import PPE Says Regulations Changing Frequently
Although the shortage of air cargo capacity matters, and the requirements for payment upfront are hurting too, attendees of a Flexport webinar on the challenges of importing personal protective equipment said their No. 1 concern is navigating import and export regulations. It's easy to see why: When Tom Gould, head of global customs for Flexport, described the Food and Drug Administration's ever-changing exceptions to its usual rules about importing medical masks, he said that they’ve “been updated a couple of times; if you looked at them a week or two ago, look again.”
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He referred listeners to a list of Chinese-manufactured masks that are not registered with the FDA. Usually, medical masks must be registered with the FDA, and the manufacturer must also be registered with the FDA; if there's a middle man, that party has to be registered with the FDA, and so does the importer. “If you show you’ve started the registration process, usually they will release it,” he said.
In addition to allowing the importation of certain Chinese masks that have not been FDA-certified (see 2004060052), Gould noted that the U.S. now allows NIOSH-certified masks, usually used in industrial or construction work, to be imported for medical purposes, and that medical masks certified by the European Union, Japan and other major countries are also allowed in.
At the same time the U.S. is loosening regulations, China is imposing stricter rules, he said. That's because there were some poor-quality shipments from China, and China doesn't want that kind of publicity. So it added new regulations and “started to actually enforce some existing regulations that had not been stringently enforced,” Gould said.
Companies exporting medical gear must be authorized to produce product for export, and they have to meet requirements in the destination country. China is now inspecting all these goods before they leave the country, a process called Customs Inspection and Quarantine (see 2004130014). “This inspection is adding one to two days, up to a week in some cases,” he said, adding that “the authorities are quickly learning how to do this process more efficiently and get the products out much more timely.” He advised American firms to tell their Chinese partners to start the CIQ process when some of the shipment is ready, not to wait until it's all done.
Gould also cautioned: “As the supply starts to flow and as masks start to become more readily available, I can see the governments clamping down and saying: 'Just meet the regular requirements.'”
Susy Schoenberg, head of Flexport's nonprofit division, said that gowns, not masks, are starting to be the biggest problems at American hospitals. She said that hospitals estimate they need 20 times their usual supplies over the next few months, and that medical supply distributors struggled to adjust to the surge.
She advised firms that are looking to supply hospitals not to secure an entire plane, but instead to let freight forwarders know you'll be sending a steady stream of cargo. “If each week, you’re shipping a few ten or hundred thousands of masks, it’s easier to procure airplane capacity,” than reserving an entire plane, she said. “It also actually helps the hospitals. Their receiving capacity is constrained.”