The FDA has simplified the authorization rules for the importation of face masks following the COVID emergency



release date: 2020-07-25

The COVID emergency has caused dramatic health emergencies on a global scale. As a result, there has been particularly strong demand for surgical masks in the US. Following the first wave of the virus, the FDA authorization procedure for importing masks was greatly simplified in order to facilitate exports from other countries and to speed up the supply chain.

The simplification of the import procedures in the USA has very specific limits, however: the templates must meet stringent requirements regarding labels and packaging. It is necessary to pay close attention to what is written on the labels of the masks in order not to leave the FDA parameters for free sale on the American market.

The types of masks normally on sale are:


  • Hygienic masks in fabric for non-sanitary use
  • Surgical masks
  • Masks DPI (FFP1 masks, FFP2, FFP3)
  • Masks N95 and KN95 (similar to FFP2)
  • Filter masks

The procedure for importing into America always includes the following steps:

It should be noted that the FDA still considers masks to be a medical device. The FDA certification procedure for some types of masks has been simplified but all the other procedures relating to the import of medical devices into the USA remain valid. Below you can find a summary list of what is needed at the FDA and American customs level for the import practice.

  • Registration of the exporting company with the FDA. The unique DUNS identification number is requested in advance;
  • Obtaining the FDA number.
  • Appointment of an FDA Agent for the American market.
  • Template labels review.
  • Registration of masks as medical devices within the FDA company account.
  • Preparation of an accompanying letter to complete the United States import customs practice.

ExportUSA can perform all FDA compliance practices for the export of masks to America. 

With ExportUSA you will have no problems with American customs and with the FDA.

We can also prepare the accompanying letter to complete the customs import procedure in the United States and you can sell the health masks on the American market without hindrance. 


Import medical devices to America

Definition of Medical Device

FDA Classification Medical Device

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