Navigate USMCA compliance for medical devices and healthcare equipment. HS classification, FDA requirements, and tariff optimization for medical manufacturers.
Importers and exporters in the medical devices industry face unique compliance hurdles:
China-sourced medical components face Section 301 tariffs
HS classification varies for similar devices
FDA compliance is separate from USMCA certification
Long product development cycles complicate origin planning
Reduce Section 301 exposure through USMCA qualification
AI-powered HS classification for medical devices
Track component origins across complex supply chains
Plan origin strategy early in product development
Paying 25% tariffs on China-sourced diagnostic equipment
Shifted component sourcing to Mexico, achieved 68% RVC
$85,000 annual savings on medical device imports
FDA approval and USMCA qualification are separate requirements. A product can be FDA-approved but not USMCA-qualified, or vice versa. You need to address both compliance requirements.
Medical devices typically require 65% Regional Value Content under USMCA, the same as general electronics. High-value components significantly impact the calculation.
Many medical device components from China face 25% Section 301 tariffs. Qualifying for USMCA through Mexico or US manufacturing can eliminate both Section 301 and MFN duties.
Explore our in-depth guides to understand tariff rules affecting medical devices:
Learn how to calculate Regional Value Content and meet the 65% threshold for medical devices.
Understand Section 301 China tariffs and mitigation strategies for medical devices imports.
Step-by-step guide to generating USMCA Form D certificates for your medical devices products.
Master HS code classification for accurate tariff calculation and USMCA qualification.
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