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What Is Required To Import PPE And Masks Into The US

COVID19 has resulted in shortages of Personal Protection Equipment (PPE) that has led many to source these goods from outside of the United States. When looking to import PPE, such as masks, it is important to be aware of the requirements for importation. 

Masks for use in a medical setting, such as a hospital are regulated by Food and Drug Administration (FDA) and are considered a medical device. 

Masks for use in a non-medical setting, for instance, a construction site, are not considered a medical device and are regulated by The National Institute for Occupational Safety and Health(NIOSH). 

To make your declaration you will be asked to supply: 

  • Photos of the product
  • Proof of certification by a governing body
  • Product specifications
  • As well as the source of the product and the destination to review for intended use

If you are looking to export these goods from the US, additional restrictions have been put in place due to the shortages. For all exportations of PPE, the exporter must seek and obtain permission from the Federal Emergency Management Agency (FEMA) prior to export. 

If you need assistance with importing or exporting these goods, or if you have any additional questions, we are here to help.

How To Import Medical Supplies Into The US
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About Author
Breanna Leininger
CCS, LCB

Breanna has been in the industry since 2004 and has dealt with clearances and compliance concerns for a multitude of commodities for all ports of entry and all modes of transportation. She has a Bachelors in Communications, Bachelors in Political Science & Government, is a Licensed Customs Broker as well as Certified Customs Specialist. Breanna has been asked to be the speaker as a variety of events including the BC Agriculture Show, Doing Business in the US seminar and has been a contributor to Smal Business BC publications She was recently nominated for the NCBFAA Government Affairs Conference Emerging Leaders and Mentors by the NBCBA. She participates in the Northern Border Customs Brokers Association and the NCBFAA annual conferences in Washington, DC. Breanna has a deep passion for politics, global affairs, and how communication shapes policy and international business relationships. She feels very fortunate to work in an industry that allows her to take part in how policy impacts the global economy and domestic businesses of all shapes and sizes.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.