HTS Classification by industry
Medical device classification straddles the line between function and technology. A device that measures blood pressure could classify under medical instruments (Ch. 90), electrical apparatus (Ch. 85), or even optical instruments — and the choice determines whether you pay 0% or 6%. With FDA product codes, EU MDR classes, and HTS classifications all overlapping but not identical, importers need precision. Camtom brings AI-powered accuracy to medical device tariff classification.
Distinguishing between medical instruments (Chapter 90 — often lower duty) and electrical medical apparatus (Chapter 85 — potentially higher duty)
Classifying combination products that include both a drug and a device under the correct primary heading
Navigating the difference between FDA device classification (Class I/II/III) and HTS tariff classification, which use different criteria
Determining whether single-use vs. reusable versions of the same device classify under different HTS subheadings
Classifying digital health devices (wearables, remote monitoring) that blur the line between consumer electronics and medical devices
Classifying an ultrasound machine under 9018 (surgical instruments) when it is an imaging device under 9022 (X-ray/radiation) or 9018.1 depending on specific type
Using a catch-all HTS code for medical instruments when a specific subheading exists for the exact device type
Classifying medical consumables (syringes, tubing) under 9018 when they belong under their material chapter (39 for plastics, 73 for needles)
Treating a medical software-as-a-service subscription as goods import when only the physical hardware component is subject to customs duties
Missing duty-free treatment for prosthetics and orthopedic devices that qualify under specific HTS provisions
Medical instruments under Chapter 90 generally face 0-4% MFN duty. Many are duty-free. Electrical medical devices under Chapter 85 may face higher rates (0-3.9%). Implants and prosthetics are often duty-free. Section 301 can add 7.5-25% on Chinese-origin devices.
Under USMCA, medical devices qualify through tariff shift rules — assembly and testing in a USMCA country generally qualifies the finished device. For some complex devices, an RVC threshold of 50-60% applies. FDA registration is separate from USMCA compliance.