Import of Emergency Medical Supplies

 

As the Covid-19 situation continues to evolve, there is undoubtedly an increased need for emergency medical supplies in the United States. Many importers around the country have stepped up to assist with providing these life-saving supplies to the general public and medical professionals. 

US Customs, FDA and the CDC are all working diligentlyto expedite the entry of products that are considered essential and with emergency need. Some items have provisions offered by FDA and the CDC for accelerated entry under the Emergency Use Authorization.

Understanding the detailed complexities of your products and engaging with Laufer as an FDA expert and US Customs Broker will allow you to navigate the intricacies of these imports.

 

Top Product Categories:

Face masks, respirators, and ventilators

Gloves, gowns, and protective clothing

Hand sanitizers and cleaning supplies

 

10 Questions and Considerations Before Importing:

Is this your first time importing any of the commodities considered under the Emergency Use Authorization?

Are you familiar with the commodity and able to answer questions like: manufacturer, country of origin, end use, etc.?

Have you purchased from this manufacturer or supplier in the past? Will you be able to obtain additional information from them, if necessary?  

What is the intended end use of the products?Are these medical/surgical grade? Intended for hospital or personal use? 

Will this shipment be delivered directly to the end-use party or a distributor? 

FDA reporting may be required for any of these emergency supplies; some masks are considered medical devices and require additional import licensing

Are any of these products branded? (ie. 3M, Tyvek) 



For US Customs and Government Agency reporting, details regarding the commodity make up will be required.Do you know the content of fabrics used in your masks and protective clothing? Do you know the active ingredients and percentages in your hand sanitizers and cleansers? 

Is documentation available to substantiate any claims made for medical or surgical use? 

Do you have specific part numbers available to identify any Emergency User Authorization approvals by the FDA and CDC? 

 

Sample Special Considerations Per Commodity:

Face masks, respirators, and ventilators

     Are they N95 / NIOSH approved?

     FDA requirements vary depending upon end use, manufacturer, and style 

     Surgical and medical grade requirements vary from personal use

HTS code and applicable duties are dependent upon fabric content and end use

     Gloves, gowns, and protective clothing

     All of these commodities may have required FDA reporting, depending upon end use

     Surgical and medical grade requirements vary from personal use

HTS code and applicable duties are dependent upon fabric content and end us

     Hand sanitizers and cleaning supplies

     Required FDA reporting – which includes data on active ingredient and percentage

     Considered an over the counter drug

     Considered hazardous material for shipping purposes and will require carrier approval and associated MSDS

 

We have compiled this information as a beginning reference point. These considerations and requirements are, by no means, a blanket to cover all products in a particular category. The import requirements are extremely detailed and varied. You should consult with Laufer to discuss the specifics of your particular imports.



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