With the spread of COVID-19, many shippers have turned to importing Personal Protective Equipment (PPE).
There is certainly high demand for PPE, like facemasks, but since these items are highly regulated, it’s important to make sure you meet all the guidelines to avoid delays or cancellations of your shipments.
We turned to the experts to get you the latest information so you can ship with confidence and efficiency.
Guidelines for Importing PPE and Masks into the US
By Robert Khachatryan
With global communities becoming heavily dependent on Chinese factories to produce masks and other Personal Protective Equipment for medical and personal use, companies have rushed to import such goods, and initially, regulations were often overlooked.
Now, as governments are catching up with the regulation of PPE imports, sellers and buyers of these critical goods often face difficulty meeting requirements. As a result, they run into delays, refusals, and in some cases confiscations of their goods. In May, the US Food and Drug Administration banned 65 of the 80 Chinese manufacturers licensed to produce N95 masks from selling them for medical use in the United States. Along with now strictly-enforced quality control regulations in China, this factory ban has generated many questions about what compliance means for this product category.
What you should know:
In the U.S., surgical, sterile, and medical masks are considered “medical devices.” Both the importer and exporter of these products are required to be registered with the FDA and the masks must have an “FDA Device Registration.”
While non-medical masks and face coverings don’t require FDA registration, they often require FDA declarations and disclosures at the time of import. US Customs or FDA often require supporting documents which may include the following:
- Photographs of the product
- Proof of certification by a governing body (country of origin and/or destination)
- Product specifications
- The source of product, along with its destination (for the review of intended use)
A note on non-medical masks:
Any claim on the packaging, labeling, marketing materials, the product itself, and even on the manufacturer’s or the importer’s website that indicates the mask or face covering is effective against coronavirus or viruses in general, or that it blocks particles or microbes, amounts to a medical claim and will render the product a non-compliant medical device. This may result in refusal of entry or seizure by customs. This applies to both export regulations in China and import regulations in the US, and in much of the developed world.
Robert Khachatryan is the Founder and COO of Freight Right, a logistics and transportation company based in La Crescenta, CA, catering primarily to technology-centric companies, including freight marketplaces, international freight forwarders, 3PLs, and other resellers of international freight. Freight Right is a provider on Freightos.com.
Guidelines for Exporting PPE and Masks out of China
Many thanks to the C.H. Robinson Asia Team for providing the following list of guidelines for PPE exports from China. Please note that policies are subject to change as COVID-19 raises constantly-evolving challenges.
China Chamber of Commerce List of Authorized Medical Supplies Companies
