Shortages in the medical equipment supply chain are causing challenges on the front lines fighting against the current COVID-19 pandemic. Specifically, a lack of nasopharyngeal swabs is slowing virus testing. Shortage of test kits and swabs makes accurate reporting and treatment difficult, if not impossible. Importing nasal swabs is one way to get these essential supplies into the hands of those who need them most. However, importing medical swabs doesn’t come without challenges.
One solution to the shortage is sourcing medical products from other countries. Importing medical swabs requires compliance with rules and regulations set by the federal government and its agencies. From sourcing swabs to figuring out FDA 501(k) notifications, an Import Expert or Licensed Customs Broker can help you make sense of it all. Working with a strategic partner, like USA Customs Clearance powered by AFC International, can help you get medical swabs into the hands of health care workers.
Medical swabs are used to test patients for viruses and infections. A health care provider uses a swab to reach behind a patient’s nose where viruses and bacteria can lurk and cause infections.
It’s important to know that medical swabs are different from the cotton Q-Tips you might have in your bathroom cabinet at home. Nasal swans are long and skinny. They have to reach the nasopharynx, which is located behind the nose in the upper throat. Additionally, the swabs must be made of synthetic materials. Rayon tipped and polyester tipped swabs are commonly used. Medical swabs used for testing can’t have cotton tips or wooden shafts. Swabs used for wound care can’t be used for testing, as these products often contain calcium alginate which kills the virus.
As companies around the world ramp up production of medical devices to combat the global health crisis, many importers are turning to sourcing medical swaps from international sources.
Small businesses, major import companies and even the United States military have all been tasked with sourcing and importing medical swabs to combat the critical shortage. In fact, the Department of Defense recently enlisted the military to help address the shortage. A C-17 cargo aircraft picked up a shipment of thousands of imported medical swabs from an airbase in Italy bound for Memphis, TN.
Some of the leading regions to source nasal swabs from include:
One creative way to address the shortage is importing medical swabs intended for animals for use in humans. According to information from the Food and Drug Administration, the agency has been working with suppliers and manufacturers of veterinary medical supplies to help meet needs in human health care. This creates opportunities for sourcing and importing medical swabs intended for use on animals from alternative suppliers.
Regardless of the source, you need an ally when you are importing medical swabs. USA Customs Clearance, powered by AFC International, can walk you through the entire import process for medical grade equipment. From offering import consulting services to help you get started to providing customs bonds to arranging shipping, we’re here to help. From importing PPE to making sense of rules around importing hand sanitizer, we can help meet unprecedented demand to meet shortages of medical supplies.
The FDA has set a few rules for those importing medical swabs. The FDA classifies each medical device on the market today. Each classification of device has different import requirements. According to the FDA’s Code of Federal Regulations, medical swabs are a Class I device. This category is reserved for low-rise devices that are proven as safe and effective.
Because medical swabs fall under FDA Class 1, in most cases, they are exempt from 501(k) or Premarket Notification (PMN). This is important in getting imported medical swabs on the market quickly, as 501(k) or Premarket Notification must be filed 90 days in advance of customs clearance. Because prior notification isn’t required for Class 1 devices like medical swabs, you’ll get your essential equipment in the supply chain quickly.
It is crucial that importers of medical swabs make sure the product and manufacturer meet all U.S. requirements for labeling and reporting. If your medical swabs don’t meet these requirements, customs clearance can be more difficult and lengthy. You can get the detailed answers you need about FDA requirements by opting for imports consulting with a Licensed Customs Broker.
It’s also important to note that you’ll likely need a customs bond when importing medical swabs. All imports are required to have a customs bond when they are subject to regulation by a federal agency. Even though the FDA guidelines for imported medical swabs are fairly lax, a bond is still necessary.
There are many benefits to opting to take advantage of customs consulting when you’re importing medical swabs. USA Customs Clearance, powered by AFC International, offers two categories of customs and import consulting services.
If you have general questions about importing, you might opt to speak with an Import Export. They can guide you through the process you’ll need to take to work with your supplier, arrange shipping and get through customs. If you have more specific questions, say about tariffs or labeling requirements for imported medical swabs, your Licensed Customs Broker can give definitive answers. Both Import Expert and Licensed Customs Broker consulting sessions are 30-minutes long and held over the phone, giving you ample time to ask questions and get solutions from anywhere.
No matter which option you choose, USA Customs Clearance, powered by AFC International, is on your side. We’ll make sure importing medical swabs and bolstering your supply chain is a hassle-free process.
Medical swabs are needed more than ever. You source the product, and we’ll handle everything else from arranging shipping to crossing customs. USA Customs Clearance, powered by AFC International, is ready to be your importing ally.
Let us show you what it means to have a strategic partner on your side when importing medical swabs. Schedule a specialist for customs consulting today to get your swabs flowing from foreign sources. In doing so, you’re keeping the medical front lines armed with crucial testing supplies.