The spread of COVID-19 in the United States has prompted an urgent need for the supply of medical devices (most prominently, personal protective equipment (PPE) and ventilators) to keep up with the corresponding increase in demand from the healthcare sector. Despite this demand, uncertainty remains due to the fluid regulatory framework which currently applies to imports of medical devices to the United States to deal with the Covid-19 Public Health Emergency. Due to the technical nature of the determinations which must be made in relation to the admissibility of medical products into the United States, and the often changing requirements during the current period, it is strongly advised that all exporters and importers consult with a customs attorney and an experienced customs broker/freight forwarder prior to shipment of such products.
In this whitepaper address some of the most important features of the U.S. system. We will summarize the export of medical devices to the United States both during the regular course of business, and, as presently modified, to maximize supply during the COVID-19 Public Health Emergency.