By Robert J. Kerwin with additional reporting by Gus Iversen

As is now well known, last Wednesday, April 2, 2025, President Trump issued an executive order imposing reciprocal tariffs on products imported from other countries. Declaring a national emergency, the president noted in his executive order the underlying conditions for imposition of the tariffs including a lack of reciprocity in bilateral trade relationships, disparate tariff rates and non-tariff barriers of trading partners.

The order, entitled "Regulating Imports with a Reciprocal Tariff to Rectify Trade Practices that Contribute to Large and Persistent Annual United States Goods Trade Deficits", has, by its terms, an intended broad application to imports including with respect to the importation of medical devices.
The president has amended the order both in response to the imposition of retaliatory tariffs and the announcement of deals on a country-by-country basis. As of this writing, the tariff situation remains fluid with the president authorizing a 90-day pause on certain tariffs to most countries. It is noteworthy that the 90-day pause does not apply to China, where the president has announced he is raising the tariff charged to 125% effective immediately.

What the executive order actually says
There is some industry wide confusion with respect to what all of this means. Looking back at the important tenets of the executive order will help. Though the April 2 executive order spans thirteen pages, the key components can be found in two paragraphs on page 7 — identified respectively as section 2 (Reciprocal Tariff Policy) and section 3 (Implementation). Section 2 imposes the ad valorem duty on imports from trading partners starting at 10 percent.

For purposes of this article, tariff, duty and tax are used interchangeably as the practical effect is to make the imported goods more expensive though the country from which the good emanates is not actually paying anything directly. The real effect is presumably that U.S. buyers are less interested in importing and will make alternative purchases domestically... or simply decline to buy.

Which tariff, which country: Check Annex I
Under the April 2 order, depending upon the trading partner, tariffs are imposed at no less than 10%. The specifics may be checked reviewing Annex I. Additional note: the tariffs imposed in Annex I could well be superseded as some countries are issuing their own retaliatory tariffs and some countries are reported to be in the process of making deals.

With regard to retaliatory tariffs, the president has signaled that he may escalate the U.S. tariffs if the trading partner places a further tariff. The president has also raised the possibility of reducing tariff charges to certain countries if these countries reduce tariffs to U.S. goods. However, this approach has not been adopted as to every country, (with China as a notable exception).

Importers scramble to meet deadlines
Importers have been scrambling since the tariffs were announced. Many initially focused on trying to get devices in transit by the April 5 start date, and are keenly aware that U.S. Customs and Border Protection (“CBP”) has said that in order to be excluded from the imposition of a tariff, the goods must reach their U.S. destination by May 27, 2025. Hence, these last few days have been characterized by one shipper who asked to remain anonymous as “nothing less than chaos.”

One industry contact shared his frantic efforts to ship a device from Japan by April 5. His Japanese counterpart was unable to load onto a vessel in time. This ultimately did not surprise him as he knew many companies were attempting to accelerate shipment to meet this April 5 deadline. And he took some small comfort in acknowledging that all parties to the transaction were apparently willing to make price adjustments to keep the deal afloat.

Could the U.S. see substantial increase in imported medical device prices?
Whether this type of compromise is the "new normal" for imports remains to be seen. By some accounts, the situation may well be here for some time. The executive order has no specific expiration date, and the president stated in his executive order, “These additional ad valorem duties shall apply until such time as I determine that the underlying conditions described above are satisfied, resolved or mitigated.“

It will be interesting to learn what happens from here as, reportedly, many countries have contacted the administration to offer concessions or presumably in some cases to inform as to plans of retaliation. However, if the tariffs continue, some medical equipment importers are predicting possible price increases on medical equipment between 25-30%.

Documentation, documentation, documentation
There also remains continued confusion as to the full scope of the tariffs, particularly as to a situation which is not uncommon in the secondary market: medical equipment manufactured in the U.S. being reimported. Will this equipment be excluded from tariffs or duties?

While the executive order itself is light on these details, medical device transport logistics provider Victor Cruz proposes a framework to avoid unnecessary costs and delays:

“Make sure the placard or data plate affixed to the device readily displays, in English, the country of origin and manufacturer, all legibly marked as well as the FDA Section 510(k) number," said Cruz, who is president of Logical Solution Services Inc. "U.S. Customs can cross-check this information, so be sure to be ready to verify your information. If this is not done, you could face delays as the equipment may be held.”

Tariff exemptions for medical devices sought
The executive order leaves in place preexisting tariffs for steel products, aluminum and automobile parts. There are also some exceptions in the order including cases wherein materials/goods are being donated to prevent or reduce human suffering, and in some existing treaties.

A range of medical device industry advocates and stakeholders are further seeking that medical equipment be exempt from these tariffs.

“Hospitals are already challenged with managing equipment budgets, and this does not help the situation when hospitals are considering medical equipment buys," Diana Upton, president of IAMERS, told HCB News. "We are hopeful that a tariff exemption will be permitted.”

"From basic supplies to lifesaving medical devices, physician practices rely on a global supply chain, yet their ability to pass on increased costs is almost nonexistent," said Anders Gilberg, senior vice president of Government Affairs for the Medical Group Management Association (MGMA), in a statement. "Practice expense calculations in fee schedules within commercial contracts and government programs such as Medicare and Medicaid are already fixed and won't account for any cost increases resulting from new tariffs or taxes."

AdvaMed, the industry group representing medical device manufacturers, issued a statement calling for medical device tariff exemption and also cosigned a letter to U.S. Trade Representative, Jameison Greer, with nine other industry groups, (American Association for Homecare, American Dental Association, America's Essential Hospitals, Association of American Medical Colleges (AAMC), Conquering CHD, Health Industry Distributors Association, Preeclampsia Foundation, Prevent Cancer, and Sepsis Alliance) calling for that exemption.

In its letter, AdvaMed cites a study from Black Book Market Research, which found that of 200 industry professionals surveyed, 80 percent expected costs for hospitals and health systems to increase by at least 15 percent in the next six months due to increased import costs.

As of this writing, there are no medical equipment exemptions, but the situation remains fluid. Even during the 90-day pause, the 10% tariff remains in effect. Given all of this, it might be appropriate to check the CBP website periodically, as it has been updated to offer several guidances.

About the authors: Robert J. Kerwin is the general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers. Gus Iversen is the editor-in-chief of DOTmed HealthCare Business News.

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