USA reviews medtech imports

On 2 September 2025, the Bureau of Industry and Security (BIS) of the US Department of Commerce opened a new investigation under Section 232. This investigation concerns imports of personal protective equipment (PPE), medical consumables, and medical devices.

The notice was submitted for publication in the Federal Register on 24 September and is scheduled to appear on 26 September. A 21-day consultation period will then begin, which is expected to end on 17 October 2025. The aim is to examine whether these imports pose a risk to US national security (e.g. excessive dependence on foreign suppliers or technologies).

The investigation brings additional uncertainty for our export-oriented industry. This makes it all the more important that we make our voice heard at the highest level. Our President Damian Müller is already in contact with Federal Councillor Guy Parmelin. Swiss Medtech is in close contact with the relevant authorities and will actively participate in the consultation process. It should be noted that this investigation affects all countries, including those that already have a deal in place.

Affected product categories

• PPE in healthcare (e.g. surgical masks, N95 masks, gloves, protective gowns)
• Medical consumables (e.g. syringes, catheters, infusion bags, suture material, laboratory reagents)
• Medical devices (e.g. wheelchairs, hospital beds, pacemakers, insulin pumps, prostheses, imaging devices, ventilators)
• Not part of the investigation: Medicines and their ingredients – these are the subject of a separate Section 232 investigation, the results of which are expected in October.

Background to the Section 232 investigation

Section 232 is a section of the US Trade Expansion Act of 1962. It gives the US Department of Commerce the authority to examine whether certain imports threaten the national security of the United States.

Procedure for a Section 232 investigation

1. Initiation of the investigation by the Department of Commerce (Bureau of Industry and Security, BIS).
2. Analysis to determine whether import dependency in a sector is critical (e.g. because too many essential goods come from abroad).
3. Public consultation in which companies, associations and other interested parties can submit comments.
4. Report to the President: The Department of Commerce submits its findings.
5. Decision by the President: He can order measures – typically tariffs or other trade restrictions – to protect national security.

Characteristic

• Section 232 is not a normal trade defence procedure (such as anti-dumping), but a security in-strument.
• It is closely managed by the government for political reasons and can rapidly lead to far-reaching measures.
   

Possible measures following a Section 232 investigation

Tariffs

• The most common measure.
• Additional tariffs on the products concerned to make imports more expensive and protect do-mestic production.
• Example: In 2018, the US imposed a 25% tariff on steel imports and a 10% tariff on aluminium imports.

Import quotas or restrictions

• Quantitative limits on how much of a product may be imported into the US per year.
• Objective: to control import volume, not just price.

Exclusions and exemptions

• The US government may exempt individual products, manufacturers or countries from measures.
• These exemptions usually have to be applied for separately.
   

Significance for Swiss medtech companies

• The US government is not questioning trade itself but is examining whether dependence on im-ports in the healthcare sector poses a security risk.
• The risk is that existing tariffs will be extended or additional barriers to access to the US market will be created.
• Quotas can limit supply capacity, even if there is demand.