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ChinaMedical Devices & Equipment2026 Rates

US Tariff on Medical Devices from China 2026

Medical devices from China generally face a 7.5% Section 301 List 4A tariff in addition to the MFN base rate (0% for most HTS 9018–9022 subheadings). The USTR granted broad exclusions for medical devices during COVID-19 (2020–2023); verify whether an exclusion still covers your product. Some devices with dual-use applications may face the higher 25% List 3 rate.

Key figures at a glance
Product
Medical Devices & Equipment
Origin country
China
Typical buyer
Medical device importers, hospital procurement, distributors
HTS hint
HTS 9018 (instruments for medical use), 9019 (therapeutic equipment), 9021 (orthopedic devices), 9022 (X-ray equipment)
HTS classification & lookup

Applicable HTS range: HTS 9018 (instruments for medical use), 9019 (therapeutic equipment), 9021 (orthopedic devices), 9022 (X-ray equipment)

Enter your 10-digit HTS code to confirm the Section 301 list assignment. Post-COVID exclusions may still be in effect for certain devices — the exclusion portal on USTR's website has the current exclusion list.

Source: USITC Harmonized Tariff Schedule, 2026 Revision 2 — hts.usitc.gov

Compliance risk notes
  • 1FDA 510(k) clearance, PMA approval, or 510(k) exemption is required for most medical devices — this is enforced at entry and is entirely separate from customs duties.
  • 2Combination products (device + drug, device + biologic) face complex FDA and tariff classification — the primary mode of action determines both FDA pathway and HTS classification.
  • 3Section 301 exclusions for medical devices granted during COVID have largely expired; confirm current status before assuming exclusion applies.
  • 4Personal Protective Equipment (PPE) such as nitrile gloves, surgical masks, and gowns may face higher Section 301 rates (25%) under List 3 rather than the 7.5% List 4A medical device rate.
  • 5Annual device registration fees and FDA establishment registration for Chinese manufacturers create additional cost of compliance beyond duties.
FAQ: What is the tariff on medical devices imported from China?

Are syringes and needles from China subject to the Section 301 tariff?

Syringes (HTS 9018.31) and hypodermic needles (HTS 9018.32) from China are on the Section 301 List 4A at 7.5%. However, COVID-era exclusions were granted for these items and may still be in effect — verify with USTR's exclusion tracker. Without an active exclusion, the 7.5% applies.

Can a hospital or healthcare system import medical devices directly from China?

Yes, anyone can be the importer of record. However, the device must be FDA-cleared/approved, and all labeling, registration, and post-market surveillance requirements apply. There is no hospital exemption from tariffs or FDA requirements.

Do tariffs on Chinese medical devices affect the device's FDA classification?

No. FDA device classification (Class I, II, III) and HTS tariff classification are independent frameworks. A device's tariff rate is determined by its HTS heading; FDA regulation is determined by intended use, risk, and device classification. They are enforced by different agencies (CBP for tariffs, FDA for device safety).

Calculate your exact landed cost

This page provides a research overview. For a precise tariff breakdown — including Section 301, Section 232, antidumping, and Merchandise Processing Fee — use the full calculator with your exact HTS code and shipment value.

Disclaimer: Informational estimates based on USITC HTS data, USTR Section 301 schedules, and public CBP ADD/CVD records as of 2026. Not legal or customs brokerage advice.

Verify all rates with a licensed customs broker before making import decisions.