Medical Device Contract Manufacturing Imports

Medical device contract manufacturing imports – where a U.S. brand contracts with overseas manufacturer for finished medical devices – face complex compliance: FDA establishment registration for the foreign manufacturer, U.S. brand as importer of record, transfer pricing implications, and potential Section 232 MedTech effects.

This guide covers U.S. import tariff and compliance for contract-manufactured medical devices.

For SMB importers in this category, the practical questions are HTS classification, applicable Section 232/301/122 stacks, FTA opportunities, and regulatory overlay (FDA/USDA/EPA/CPSC where relevant).

HTS classification basics

Varies widely by device type. Most under HTS 9018 or related medical chapters.

Tariff stack and rates

Base typically 0% + Section 122 (15% on non-USMCA) + potential Section 232 MedTech.

Country of origin considerations

Mexico (Tijuana cluster), Costa Rica, Dominican Republic, Singapore, China for various devices.

Regulatory overlay

FDA foreign establishment registration. Contract manufacturer cGMP audits. Quality agreements between brand owner and CMO. FDA 510(k) holder is U.S. brand.

Mitigation opportunities

USMCA qualification on Mexican CMO production. Costa Rica CAFTA-DR. Transfer pricing alignment with customs valuation.

Frequently asked questions

What is the typical effective duty rate?

Depends on origin and HTS classification. China-origin: 22-42% effective when Section 301 + Section 122 stack. USMCA-qualifying Mexican production: often 0-3%. Vietnam, India, Korea: 15-17% with Section 122.

Can I qualify under USMCA?

Possible if production occurs in U.S., Mexico, or Canada and meets rules of origin (typically 60% RVC under transaction value or 50% net cost). USMCA-qualifying goods are exempt from Section 122.

Are IEEPA refunds available?

Yes – for entries between April 5, 2025 and February 24, 2026 that paid IEEPA duty. Filed through CBP’s CAPE portal. We file claims on contingency for filings above $50k.

What about Section 232 exposure?

Specific to product type. Steel and aluminum derivatives expansion brought some downstream products into scope. Component-level analysis identifies actual coverage.

How do you help with this category?

Tariff exposure assessment ($2,500-$7,500), classification audit, USMCA qualification, refund recovery, audit response. Independent of any customs brokerage.