Medical Devices from South Korea — KORUS 0% Duty (2026)

USTradeStack

Effective Duty Rate

0% KORUS FTA for most medical devices

Estimate — verify by HTS code

Compliance Risk

Low

Relative to other import corridors

Regulatory Agencies

FDA, EPA, FCC

Primary oversight bodies

OVERVIEW

Importing Medical Instruments, Devices & Diagnostic Equipment from South Korea

Importing medical devices from South Korea into the United States carries low compliance risk, with an effective duty rate of 0% KORUS FTA for most medical devices. A Section 232 Tariff Rate Quota (TRQ) arrangement applies: steel and aluminum products within quota limits may enter at reduced or zero Section 232 duty, while above-quota imports face the full 25% surcharge.

Medical Devices imported from South Korea to the United States is subject to CBP entry requirements, applicable HTS-based duty rates, and agency compliance clearances. This guide covers the complete import process for 2026.

⚠ Key Trade Intelligence — South Korea Origin

KORUS FTA provides zero-duty access for Korean medical devices. Samsung Medison, Osstem Implant, and other Korean manufacturers are growing US market presence.

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SAMPLE LANDED COST — $50,000 SHIPMENT

Estimated Landed Cost: Medical Devices from South Korea

Based on a representative $50,000 CIF shipment value. Actual costs vary by HTS code, entry type, and port of entry.

Cost Component	Amount	Notes
Cargo Value (CIF)	$50,000.00	Reference shipment value
MFN Base Duty (0.0%)	$0.00	KORUS preferential / ITA zero-rate
Merchandise Processing Fee (0.3464%)	$173.20	Min $31.67 / max $614.35
Harbor Maintenance Fee (0.125%)	$62.50	Ocean freight only
Total Duties & Fees	$235.70	Effective rate: 0.5%
Estimated Landed Cost	$50,235.70	Cargo + all US duties/fees

⚠ Section 232 tariffs (25% steel / 10% aluminum) may apply to medical devices sub-categories with significant steel or aluminum content. Not included above — verify by specific HTS code.

✓ KORUS preferential rates reduce base duty to 0% for qualifying goods. MPF and HMF still apply on all entries.

Excludes freight, insurance, broker fees, warehousing, and AD/CVD duties. Use the Duty Calculator for a precise estimate on your specific shipment.

APPLICABLE HTS CODES

HTS Codes for Medical Devices Imports

The following Harmonized Tariff Schedule (HTS) codes typically apply to medical devices imports. Exact classification depends on the specific product — misclassification is one of the most common CBP compliance errors.

HTS Code	Product Description	MFN Base Duty Rate
9018	Medical, Surgical & Dental Instruments (general)	0%–5.4% MFN
9019	Mechano-Therapy & Massage Apparatus	0% MFN
9021	Orthopedic Appliances, Prostheses & Hearing Aids	0% MFN
9022	X-Ray & Radiation Equipment (diagnostic/therapeutic)	0%–2.1% MFN
9027	Instruments for Physical/Chemical Analysis (lab diagnostics)	0%–3% MFN

MFN rates reflect base tariff. Additional duties (Section 301, Section 232, AD/CVD) may apply on top of MFN rates. Use the AI classifier to get the exact 10-digit HTS code and all applicable rates for your specific product.

DUTY STACK — SOUTH KOREA ORIGIN

Total Tariff Cost for South Korea-Origin Medical Devices

Duty Layer	Rate / Status	Applies To
MFN Base Rate	Varies by HTS code	All South Korea-origin goods (baseline)
KORUS Preferential Rate	Reduced / 0% (qualifying goods)	Goods meeting KORUS rules of origin
Section 301	Not applicable	South Korea-origin goods are not subject to Section 301
Section 232 TRQ	0% within quota; 25%/10% above	Steel/aluminum within agreed quota volumes

Precise Duty Calculation

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Our calculator handles all duty layers — MFN + Section 301 + Section 232 + FTA rates — for any HTS code from any origin country.

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COMPLIANCE — FDA / EPA / FCC

US Compliance Requirements for Medical Devices Imports

Regardless of origin country, medical devices imports must satisfy the following US regulatory requirements before or at the time of CBP entry filing:

FDA 510(k) premarket notification or PMA (Premarket Approval) required — device classification (Class I, II, or III) determines regulatory pathway
FDA Establishment Registration and Device Listing — foreign manufacturers and US importers must register with FDA annually and list all marketed devices
FDA Unique Device Identification (UDI) labeling — medical devices must bear UDI on labels and packaging per 21 CFR Part 801
EPA/FDA radiation-emitting product standards (21 CFR Parts 1000–1050) for X-ray, laser, ultrasound, and MRI equipment

Compliance Check Tool

Run an automated compliance check for your medical devices import — identifies all applicable agency requirements, flagging issues before your shipment departs South Korea.

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REQUIRED DOCUMENTS

Documentation Checklist for Medical Devices from South Korea

Prepare all documents before the shipment departs South Korea. Missing or incorrect documents are the #1 cause of CBP holds and customs delays.

1

Commercial Invoice with device name, model, and FDA product code

2

Packing List

3

Bill of Lading or Airway Bill

4

FDA 510(k) clearance letter or PMA approval letter

5

FDA Establishment Registration number and Device Listing confirmation

6

UDI label and GUDID (Global Unique Device Identification Database) registration

Document Generator

Generate Your Document Checklist

Get a customized document checklist based on your specific HTS code, origin country, and product category.

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ESTIMATED TIMELINE

Import Timeline — Medical Devices from South Korea

3–10 days (air freight for most devices); 15–30 days (ocean for heavy/bulk equipment)

Supplier Preparation

Allow 1–2 weeks for production documentation, certificates, and packing lists

Transit Time

18–35 days ocean from Asia/origin

CBP Clearance

1–3 days standard; 5–15 days if examination or AD/CVD review required

FREQUENTLY ASKED QUESTIONS

FAQs — Importing Medical Devices from South Korea

What is the effective US tariff rate for importing medical devices from South Korea?

The effective US tariff rate for medical devices from South Korea is: 0% KORUS FTA for most medical devices. KORUS FTA provides zero-duty access for Korean medical devices. Samsung Medison, Osstem Implant, and other Korean manufacturers are growing US market presence.

What compliance agencies regulate medical devices imports from South Korea?

Medical Devices imports require compliance with: FDA, EPA, FCC. Specific requirements include: FDA 510(k) premarket notification or PMA (Premarket Approval) required — device classification (Class I, II, or III) determines regulatory pathway and FDA Establishment Registration and Device Listing — foreign manufacturers and US importers must register with FDA annually and list all marketed devices.

What documents are required to import medical devices from South Korea?

Required documents include: Commercial Invoice with device name, model, and FDA product code; Packing List; Bill of Lading or Airway Bill; FDA 510(k) clearance letter or PMA approval letter. Additional: FDA Establishment Registration number and Device Listing confirmation; UDI label and GUDID (Global Unique Device Identification Database) registration. Ensure all documents are prepared before the shipment departs South Korea.

How long does customs clearance take for medical devices from South Korea?

Typical timeline: 3–10 days (air freight for most devices); 15–30 days (ocean for heavy/bulk equipment). CBP clearance typically takes 1–3 business days for compliant entries. Complex entries (AD/CVD, formal entry review, or examination) may require 5–15 additional business days.

Are there Section 301 or Section 232 tariffs on medical devices from South Korea?

No Section 301 tariffs apply to South Korea-origin goods. Section 232 applies with a TRQ arrangement — steel within quota enters at reduced/zero Section 232; above quota faces 25%.

What FDA registration and 510(k) clearance requirements apply to imported medical devices?

Medical devices imported into the US are regulated under the FD&C Act, 21 CFR Parts 800–898. Requirements vary by device class: Class I (low risk) — most require FDA registration and listing but not premarket review; Class II (moderate risk) — most require 510(k) premarket clearance demonstrating substantial equivalence to a predicate device; Class III (high risk) — require Premarket Approval (PMA). Foreign manufacturers must register with FDA and list all devices annually. FDA Import Alerts can block shipments from specific manufacturers for GMP non-compliance. All devices require labeling in English meeting 21 CFR Part 801 requirements.

What HTS codes and duty rates apply to medical device imports?

Medical devices span multiple HTS chapters. Key categories: surgical instruments (9018.11–9018.90): 0%–2.9% MFN; diagnostic imaging equipment (9022): 0%–1.2% MFN; orthopedic implants (9021): 0% MFN; hospital furniture (9402): 0%–2.4% MFN; laboratory instruments (9027): 0%–3.9% MFN; contact lenses (9001.30): 2% MFN; single-use medical products (sterile, Chapter 30): 0%–6.5% MFN. Most medical devices have low or zero MFN duty rates. However, Chinese-origin medical devices face 25% Section 301 for many categories — verify your specific HTS code against USTR lists.

How do UDI (Unique Device Identification) requirements affect medical device imports?

FDA's UDI rule (21 CFR Part 830) requires that most medical devices distributed in the US have a Unique Device Identifier on the device label and direct marking. The UDI must be submitted to FDA's Global Unique Device Identification Database (GUDID). Implementation was phased in by device class — Class III devices had earliest compliance dates, Class II and Class I followed. Importers must verify that the foreign manufacturer's UDI labeling meets FDA 21 CFR 830 requirements and that GUDID submission is current. Non-UDI-compliant devices are subject to FDA action.

What does the KORUS FTA cover and how do I claim preferential treatment?

The US-Korea Free Trade Agreement (KORUS, effective 2012) has phased out duties on the vast majority of US-Korea trade — most goods now enter at 0%. To claim KORUS preference, have a valid origin certification from the Korean exporter (self-certification is permitted under KORUS). Goods must meet KORUS rules of origin requiring sufficient production in the US or Korea, with country-specific RVC or tariff shift rules by HTS code.

Are Korean electronics (Samsung, LG, SK Hynix) subject to any additional US tariffs?

No. South Korea is not subject to Section 301 tariffs. Section 232 TRQ applies to Korean steel and aluminum, not electronics. Korean electronics benefit from both KORUS FTA (0%) and the ITA (0% WTO multilateral rate), providing dual zero-rating. Major Korean brands have extensive US operations that further simplify compliance for distributors and importers.

How strictly does CBP enforce KORUS rules of origin for auto parts?

CBP has significantly increased KORUS auto parts origin verification, particularly for vehicles and major components. Importers should obtain detailed origin certifications from Korean suppliers including net cost calculations and production records. Korean auto parts manufacturers supplying global OEMs typically maintain robust KORUS documentation — request it proactively rather than waiting for a CBP CF-28 inquiry.

TRADE INTELLIGENCE TOOLS

Free Tools for Medical Devices Importers

Run these tools before your next shipment from South Korea — all free, no account required.

🔍 AI HTS Classifier

Get the exact 10-digit HTS code for your medical devices. Identifies Section 301/232 exposure.

🧮 Landed Cost Calculator

Calculate total duty including MFN + Section 301 + Section 232 for South Korea-origin goods.

🛡️ Supplier Screening

Screen your South Korea supplier against OFAC, BIS Entity List, and denied parties databases.

✅ Compliance Check

Verify FDA/EPA/FCC requirements and identify documentation gaps before shipment.

📊 Trade Research Hub

Deep-dive on tariff policy changes, Federal Register notices, and regulatory updates for South Korea.

🔔 Tariff Alerts

Get notified when duty rates or compliance requirements change for your product corridors.

Ready to Calculate Your Exact Import Costs?

Get precise duty calculations, landed cost estimates, and compliance flags for your medical devices shipment from South Korea.

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View full South Korea tariff profile → Browse all import guides → Calculate landed cost →

Import duty rates are sourced from the USITC Harmonized Tariff Schedule and USTR Section 301 lists. Rates reflect current published schedules as of 2026-05-16 and are subject to change. This page is for informational purposes only and does not constitute legal or customs brokerage advice. Verify rates with a licensed customs broker before importing.

How to Import Medical Devices from South Korea to the US