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.