The Trump Administration has initiated a Section 232 investigation into medical equipment and devices that began on 02 SEP 2025. Section 232, part of the Trade Expansion Act of 1962, allows the Secretary of Commerce to determine the effects on the national security of imports of personal protective equipment, medical consumables, and medical equipment including devices.
Section 232 allows the President to impose restrictions on imports, or to negotiate with trading partners following an investigation that determines an import poses a “threat to impair” U.S. national security. Under the rule, investigations may be initiated based on an application from an interested party, a request from the head of any department or agency, or may be self-initiated by the Secretary of Commerce.
In a five-page notice posted to the Federal Register on 24 SEP 2025, the Department of Commerce noted that it is focused on national security and getting rid of supply chain risks that could be associated with importing foreign medical devices. The notice also said the Department is interested in increasing domestic production of devices. The report specifically called out cardiovascular, diabetes, orthopedics, imaging systems, and respiratory devices.
This is not the first time Section 232 has been imposed by the Trump Administration. It also imposed the rule on automobiles, copper, steel, and aluminum. This has allowed Trump to ensure that tariffs against these items remain intact, even if a court rules them illegal. Automobiles and auto parts specifically have a 25% tariff under Section 232; however, are given an exemption if they comply with trade agreements or assembly in the U.S.
The Section 232 investigation is ongoing, and the Department of Commerce now has 270 days to provide a report to President Trump. Any action will likely not be seen until 2026. “The outcome of this investigation and subsequent actions are uncertain at this time and could create volatility for medtech stocks over the coming quarters. Most medical device companies have already baked in some tariff headwinds, but new tariffs could be another headwind to margins,” equity research firm, William Blair, wrote in a report. “Further, some medical device companies are exempt from the most recent round of tariffs under the Nairobi Protocol, but, in our view, Section 232 could give the administration a reason to overrule these exemptions.”
“We believe that the Section 232 investigation creates a new overhang for the already beleaguered medical device sector but that the actual impact of any new tariffs depends on companies’ ability to pass through the costs to customers,” a report from Needham concurred.
REFERENCE: Medical Device and Diagnostic Industry (MD+DI); 26 SEP 2025; Clair Wallace