Medtech importers face a US Commerce Department investigation and potential tariffs

The U.S. Commerce Department has initiated an investigation into whether medical device imports pose a threat to national security, according to a notice scheduled to be published in the Federal Register tomorrow.

The notice seeks public comment, saying that U.S. Secretary of Commerce Howard Lutnick initiated an investigation under Section 232 to determine the effects on national security of imports of personal protective equipment, medical consumables, and medical equipment, including devices.

The notice listed potential examples of medical consumables as including medical/surgical instruments (e.g. syringes, needles, infusion (IV) pumps, forceps, scalpels); medical/surgical supplies (e.g. intravenous (IV) bags, catheters, tracheostomy tubes, anesthesia equipment, gauze/bandages, sutures, diagnostic and laboratory reagents); and related medical parts and components. Medical equipment could include carriages and wheelchairs; crutches; and hospital beds.

Examples of medical devices could include: pacemakers; insulin pumps; coronary stents; heart valves; hearing aids; robotic and non-robotic prosthetics; blood glucose monitors; orthopedic appliances; electromedical apparatus (e.g. computed tomography scanners, magnetic resonance imaging machines); electrosurgical apparatus; X-ray apparatus/other radiation equipment; respiratory machines (e.g.ventilators, respirators, oxygen apparatus); and MRI machines.

Related: There’s a shortage of life-saving devices for kids — and tariffs might make it worse

The U.S. Commerce Department is seeking comments and information on the role of imported medtech and overseas trade policies, how they affect domestic supplies, and how changes to trade policy and tariffs could address some of the challenges. If these devices are subject to additional tariffs, that would likely increase costs for the hospitals and patients who pay for them.

Scott Whitaker, CEO of U.S. medtech trade group AdvaMed, argued in a statement that the investigation would show that U.S. medical device manufacturing is strong.

“Our industry is a uniquely American manufacturing success story and leads the world in medical innovation, providing American hospitals, doctors’ offices, and patients the highest-quality medical technologies in the world. Seventy percent of the medical products that American hospitals and patients rely on are made in America across thousands of manufacturing facilities in all 50 states. Additionally, since 2019 medtech jobs have grown at three times the average manufacturing job rate, thanks in large part to sound tax policies, such as the OBBB, the TCJA, and the medical device tax repeal. We look forward to continuing our work with the administration, including through the Commerce department’s investigation, to strengthen our already-robust and uniquely American industry. We believe this process will reinforce the fact that U.S. medtech manufacturing is strong and lower tariffs will fuel more manufacturing and job growth in the U.S., which means greater access to lifesaving technologies and lower costs to American hospitals and patients.”

Previously: AdvaMed warns of device cost increases and patient harm from tariffs

In a statement shared with Medical Design & Outsourcing, Dutch medtech giant Philips acknowledged the investigation and said potential options remain under discussion.

“At this stage, no immediate operational or financial impact should be assumed,” the company said. “This process will take time, and there are established channels for stakeholder input. Philips remains focused on ensuring continued access to medical technologies for patients and healthcare providers in the U.S. market. We will continue to monitor developments closely and provide updates as the situation evolves.”

Previously: Intuitive’s trade war strategy holds lessons for other device developers