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Importing PPE into the U.S.

During the COVID-19 pandemic, nothing has been more valuable than PPE (Personal Protective Equipment). Here’s what you need to know before importing PPE into the U.S.

PPE for medical facilitiesMask_Sanitizer_pexels-gustavo-fring-4000621

If the product is being sold or going to be sold to medical facilities, the importer must:

  • be registered with the FDA (Food and Drug Administration)
  • have the name and address for the actual manufacturer. Note: You cannot use a distributor name and address that you are buying from.
  • have harmonized tariff numbers
  • have FDA codes

The FDA also has specific requirements for masks and hand sanitizer.


Read more about mask requirements here.

  • Manufacturer contact information: name and address of business, email address, contact information for a U.S. agent (if any)
  • General information about the device such as the proprietary or brand name, model number (if any)
  • Copy of the product labeling
  • Estimate of the number of surgical masks you are planning to market and distribute during the public health emergency
  • Summary of the evidence demonstrating that the surgical mask meets the above criteria, including test reports
  • List of authorized distributor(s) and/or authorized importer(s), including contact information (name, address, contact person, phone number, and email).

Hand sanitizer

Read more about hand sanitizer requirements here.

  • Foreign manufacturer registration
  • Importer registration with FDA as an over-the-counter drug manufacturer, re-packager, or re-labeler (if making your own)
  • FDA drug listing number
  • FDA drug registration number

PPE for general and industrial use

Personal protective equipment for general purpose or industrial use—that is, products that are not intended for use to prevent disease or illness—are not regulated by FDA.

They can be disclaimed. However, it is important that there is some sort of writing or documentation advising that the items are not going to be used in medical facilities.

Know your source

Many importers have wanted to pitch in during the pandemic crisis, often importing PPE products that are outside of their usual imports.

However, this comes with some risks:

  • If PPE products are not the usual items you trade in, importing fraudulent items or from disreputable manufacturers can affect your ability to import your main products.
  • If you’re found to be importing suspicious product, your company is then identified in CBP’s and/or FDA’s system. This could mean additional reviews, inspections, or requests for information during subsequent imports.

It’s extremely important to know who is manufacturing the product. As an importer, you need to know who you are buying from and that they are a reputable company.

Don’t let PPE imports impact your core business—we are here to help. If you are unsure of proper procedure for importing PPE products into the United States, contact Cole’s US Consulting division today.

Contact us today!

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