COVID-19 continues to drive enormous demand in the U.S. for personal protective equipment (PPE). To help meet that demand, both the U.S. and Chinese governments are expediting processes to speed importation of PPE products into the U.S.
Nevertheless, you still need to understand the nuances of PPE-specific rules imposed by both the imposed U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration—especially if you plan to import medical-grade equipment.
And remember— these rules are subject to rapid change in the age of COVID-19. If you need help navigating them, feel free to contact us.
In the meantime, here's a quick overview of:
The current state of the U.S. market for PPE
Rules governing PPE imports.
The Huge U.S. Market for PPE Imports
The world is not expected to roll out a vaccine for COVID-19 before 2021 at the earliest. In the meantime, the US market for imported PPE—especially from China—is expected to remain extremely robust for three key reasons:
U.S. manufacturers can't keep up. U.S. manufacturers are not coming close to current demand, according to USA Today, and will likely take years to catch up.
China manufacturers dramatically increase production. China, already the world's leading PPE manufacturing before COVID, has massively ramped up production, reports the New York Times. from March to May 2020 alone, China exported more than 70 billion masks.
U.S. and China expedite PPE trade. The U.S. FDA is speeding and simplifying the importation of PPE for "immediate, urgent public health needs." Meanwhile, China has set new rules to ensure the quality of its PPE exports.
Basics of Importing PPE into the US
There are three principle categories of PPE, each of which is governed by a different set of importation rules:
1. Non-medical-grade PPE
Currently, PPE for personal or industrial use is not subject to the FDA rules and doesn't require FDA reporting. At the time of entry for these products, importers simply need to transmit entry information to US Customs and Border Protection (CBP) :
Using the appropriate HTS code without transmitting anything to the FDA
OR, the appropriate HTS code with an FD1 flag and do a ‘disclaim’ for FDA.
Contact us if you have questions about specific products you plan to import, and we can review for any FDA reporting requirements.
2. Expedited Medical-grade PPE and Other Equipment
Thanks to emergency use authorization (EUA), the FDA has streamlined both the documentation and inspections processes for many kinds of medical-grade PPE and other medical equipment used to treat and/or prevent COVID. To qualify for EUA, entries must be transmitted with proper FDA information, including:
Intended Use Code of 940.000: Compassionate Use/Emergency Use Device
At writing, the following types of products may qualify for EUA:
Respirators
Face Masks (non-surgical)
Diagnostic tests kits
Ventilators and related accessories
Face shields
Respirator decontamination systems
Extracorporeal blood purification devices
Infusion pumps and infusion pump accessories
Diaphragmatic pacing simulator systems
Continuous renal replacement therapy and hemodialysis devices
Remote or wearable patient monitoring devices
Respiratory assist devices
This list is subject to change. Get the latest list of EUA devices and importation rules here.
3. Other Medical-Grade PPE and devices.
Certain medical-grade equipment has not yet qualified for EUA, but can still benefit from expedited customs clearance. For these products, entries must transmit with proper FDA information and:
Intended Use Code 081.006: Enforcement discretion per final guidance
The current rules for different products in the category vary and are subject to change. Consult the latest rules here.
In the meantime, we are happy to answer your questions about PPE, so please contact us.