By Kristin Chambers
April 16, 2020
As medical-grade masks become increasingly rare in the United States, many importers are turning to the PPE category in an attempt to reduce the shortage. However, businesses unfamiliar with the process of importing medical equipment may encounter obstacles with FDA registration and licensing, delaying the much-needed shipments further. With years of expertise in the freight industry, Sheltered International can help facilitate this importing process to ensure medical personnel and first responders can access this necessary equipment as soon as possible.
With this knowledge, Sheltered International has imported 3,000 surgical masks and 100 face shields, to be donated to local Nassau County first responders. Chief Hurley of the Fernandina Beach Police Department, Sheriff Leeper of the Nassau County Sheriff’s Office, and Kaleigh Simmons of the Fernandina Beach Fire Department will each receive 1,000 masks.
The Availability of Personal Protective Equipment
Though personal protective equipment is available, it is in limited quantities. Many importers new to the medical supply industry are looking to place large orders of surgical masks in numbers of five million or more. With only several factories in China producing medical-grade masks, this order can be difficult to fulfill. Instead, Sheltered International suggests placing smaller orders weekly, particularly for those new to the industry. An order of 50,000 masks a week is both more manageable and more likely to be filled.
Managing FDA Registration
To expedite the import of PPE, the FDA has reduced the amount of information required to register products for nonmedical use; however, for medical use both the factory and importer of record must register with the FDA. For the importer, this license costs $5,238. Sheltered International is available to help importers navigate the registration process, saving them valuable time and ensuring their shipment doesn’t get caught in customs.
Importers must also remember that both they and the shipper need FDA registrations. Though many factories, including toy factories and clothing companies, have converted their facilities to make surgical masks, these factories are often not FDA registered. As such, they cannot ship or market their masks for medical purposes. If looking to import as a medical supplier, importers can ask Sheltered International to confirm FDA registration of the factory.
Chinese Restrictions on Medical Exports
On April 10, China issued additional restrictions on exports, including a mandatory customs inspection. These policies affect any medical supplies, including medical masks, protective gowns, thermometers, ventilators, surgical caps, goggles, gloves, shoe covers, ICU monitors, disinfectant tissue, and disinfectant.
New restrictions require the shipper to provide an 18-digit Code of Customs Clearance Form of Export Commodity for customs clearance, attained after the product receives its export commodity inspection, or CIQ. If the shipper’s name is not the same as the factory’s, a contract must be established between the shipper and producer. These codes are required per shipment and can take at minimum two to three working days; however, with a significant uptick in applications anticipated after these new restrictions were established, this timeline may extend to five to seven days, though the application can be done during production. Though they are likely to slow production and importing of PPE, advocates of the restrictions say these regulations have been established to prevent counterfeit goods from entering the market.
Facilitating Imports of PPE
For importers unfamiliar with the medical supply industry, registering with the FDA and securing the necessary documentation can be overwhelming. With years of experience in customs and freight shipments, Sheltered International can offer valuable insight into facilitating this process and guaranteeing these much-needed supplies can be delivered to those who need them.