Personal Protective Equipment (PPE) refers to all protective clothing, helmets, gloves, face shields, goggles, facemasks, and other equipment designed to protect the wearer from injury or the spread of infection or illness. If PPE is intended to be used as a medical device, then it must conform with the FDA (Food & Drug Administration) regulations.

The COVID-19 pandemic has made us realize that the United States and many other countries around the globe are dependent upon a well-functioning global supply chain of critical medical supplies for those who are in the front lines as well as for the general population.

All the challenges and hurdles of normal logistics have been accentuated by the current global pandemic. To illustrate this let’s look at what happened with N95 masks.

Some of the U.S. companies selling N95 masks have U.S. manufacturing facilities, however, most masks were being manufactured overseas, mostly in China, which in normal times is not a problem. Immediately after the pandemic outbreak, China acted fast in protecting most of the N95 masks along with other PPE manufactured in that country to ensure local doctors and other health professionals caring for COVID-19 patients were well supplied. Then, as the virus spread beyond China, the governments of other countries producing N95 masks such as France, Germany, South Korea, and the United States bought up available supply, and restricted export of these commodities out of their countries. As a result, in a few short weeks, the global market of this PPE went into a halt,.

The Two Most Important Issues to Consider Before Buying PPE to Import into the US:

1) Can the Product be exported from the Country of Origin?

First, you must confirm if the supplier is duly licensed and certified at origin and if the product can be exported from that country.  For example, if your PPE supplier is from China you need to know that the government of that country issued very strict rules on April 1st, 2020, mandating that all exports of PPE need the approval of China’s National Medical Products Administration (NMPA) for the supplier/model combination.  Otherwise, Chinese Customs authorities will detain the shipment before departure. Many promising deals have fallen through the cracks at this stage because the Chinese manufacturer did not have China NMPA’s approval.

2) Can the Product be imported, sold, and used in the US?

The importation of all medical devices including PPE requires the approval of the U.S. Food and Drug Administration (FDA).  The eligibility of certain products is changing constantly as FDA progressively has loosened restrictions on imports of certain PPE products to fulfill the demand.  One of the many releases issued by the FDA to the public took place in April 2020: “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” which allowed the importation of Chinese-designed “KN95” respirator masks that are equivalent to U.S.-designed N95 masks but not FDA approved for medical use. The FDA rules are changing very rapidly, therefore we urge importers of PPE to keep up with these changes by always checking the FDA website www.fda.gov.

Take note that the manufacturer must register their company with the FDA, as well as the products or medical devices they produce if they are intended to be exported to the U.S. Also, the importer must register with the FDA as ‘importer of medical devices’. As part of its due diligence, the importer must request from the manufacturer the device or product FDA registration number and validate with the FDA that indeed the item is registered. The shipper at origin, if different from the manufacturer, must also register with the FDA as a provider to these products.

We urge all importers to hire a seasoned licensed Custom Broker to help with the import and customs entry process. When contacting a customs broker have the following information available:

  • Country of origin of the product
  • Importation Product Code, which is a combination of the FDA Panel and Product Code
  • Product description
  • Manufacturer’s name and details
  • Information about the shipper
  • Applicable “Affirmation of Compliance” codes (from the FDA)
  • Harmonized Tariff Schedule (HTS) code for the product described in the importing documents.

Licensed Customs Broker and Freight Forwarder Ready to Help

Hiring an expert is the best way to ensure that you don’t miss any critical information when it comes to the import of PPE. As a licensed US Customs Broker, Promptus is always on top of the latest updates in the industry and can work closely with your business to ensure that you are up-to-date on all import and export proceedings as well. Contact us today at 1-877-776-6799 for a quote.