Importing N95 Masks & PPE

Thinking about importing N95 masks and PPE to help with COVID shortages?

There has been an increase in demand at the Food & Drug Administration (FDA) for importers seeking to import Personal Protective Equipment (PPE).  The FDA has issued Emergency Use Authorizations (EUA) clarifying which types of PPE can be imported without going through the FDA, which include guidelines for ventilators, remote monitoring devices and N95 respirators for non-medical use and diagnostics.

The EUA’s have been created to facilitate and expedite the clearance process with Customs and FDA for the increased need of the PPE items during our current Pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to the COVID-19.

What kind of PPE?

  1. Products that are not intended for use to prevent disease or illness are NOT regulated by the FDA. These products can be processed through the US Customs and Border Protection (CBP).
  2. Diagnostic Test & Masks/Respirators.  These fall under the EUA regulations and must go through the FDA. However, reduced information is required.
  3. Products that do not fall under EUA regulations but ARE intended to help prevent disease or illness.  

Thinking About Importing?

Gallagher Transport’s team of brokers is here to help.  If you are thinking about importing for the first time, please answer the questions below.

  1. Have you ever imported before?
    • Have you confirmed your supplier and/or manufacture is registered with FDA?
  2. Have you already purchased the product?
    • We’ve had some clients lose out to higher bidders.  Ensure you have already purchased the product.
  3. Is the product already made and ready to ship?
    • We start the import process once the product is ready to ship.

If you answered yes to the questions above, the quickest way for us to get you a quote is for you to EMAIL us the following info:

  1. Who is arranging the freight and insurance;  you or the manufacturer?
  2. Name
  3. Pickup address
  4. # of pieces
  5. Weight
  6. Dimensions

Shipping

Due to limited space with the airlines, airfreight rates are currently at a premium and delayed. Ocean freight is an option, but transit time is considerably longer.

Exporting PPE

Please note PPE items are not allowed to be exported currently at this time.  Any of the necessary PPE items needed during the COVID—19 pandemic should remain in the United States for domestic use

Not sure what to do?  You are welcome to call 303-365-1000We are happy to answer your questions.