Verified 2026 United States Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: South Korea to United States

Full 2026 tariff breakdown, customs duty calculations, and compliance alerts for importing into United States.

HTS Code9018.90

Why Customs Classification Matters for Medical Devices

Importing medical devices from South Korea to the US can be complex due to stringent regulations. The US FDA requires compliance with its rules, including registration, listing, and premarket approval. Additionally, importers must comply with the Federal Food, Drug, and Cosmetic Act and other relevant laws. The lack of understanding of these regulations can lead to delays, fines, or even rejection of shipments. Furthermore, the US harmonized tariff schedule imposes tariffs on certain medical devices, ranging from 0% to 4.5%. The complexity of these regulations can be overwhelming for importers, making it essential to have a deep understanding of the compliance requirements.

Cost Breakdown

Component	Rate	Amount
Product Value	—	USD 15000.00
Shipping	—	USD 1200.00
Insurance	—	USD 150.00
CIF Value	—	USD 16350.00
Customs Duty	8.5%	USD 1389.75
Merchandise Processing Fee (MPF)Min $31.67, Max $614.35	0.3464%	USD 56.64
Harbor Maintenance Fee (HMF)	0.125%	USD 20.44
VAT/GST	N/A (state sales tax varies)	USD 0.00
Total Landed Cost	—	USD 17816.83

Step-by-Step Import & Compliance Guide

To ensure compliance with US regulations, importers can follow a step-by-step guide: 1) Register with the FDA and obtain a registration number; 2) List their devices with the FDA; 3) Obtain necessary certifications, such as ISO 13485 and CE marking; 4) Ensure compliance with labeling, packaging, and testing requirements; 5) Implement the FDA's UDI system and cybersecurity requirements; 6) File EEI and comply with AES regulations. By following these steps, importers can ensure that their medical devices meet US regulations and avoid delays, fines, or rejection of shipments.

How Much Does It Cost to Import Medical Devices into United States?

When importing Medical Devices from South Korea to United States, the applicable customs duty rate is 8.5% on the CIF value (Cost + Insurance + Freight). Additionally, a VAT/GST of N/A (state sales tax varies) is applied on the dutiable value. The total landed cost depends on your specific product value, shipping method, and insurance — use the calculator above to get an exact breakdown for your shipment.

These rates are based on 2026 tariff schedules and may vary depending on the precise HS code finalization by customs and any applicable trade agreements between South Korea and United States.

HS Code 9018.90 — Customs Classification for Medical Devices

Medical Devices is typically classified under HS Code 9018.90 when imported into United States. At this classification, the customs duty rate is 8.5%. Accurate classification is critical — ensure your commercial invoice and packing list explicitly reference this HS code.

Misclassification can result in shipment delays, penalties, or overpayment of duties. If trade agreements exist between South Korea and United States, a certificate of origin may qualify your goods for preferential (reduced) duty rates.

Frequently Asked Questions

What is the FDA registration process for medical devices?

The FDA registration process involves submitting an online application and paying a registration fee.

What is the Harmonized Tariff Schedule (HTS) code for medical devices?

The HTS code for medical devices ranges from 9018 to 9022.

Do I need to obtain a certification for my medical device?

Yes, importers must obtain necessary certifications, such as ISO 13485 and CE marking.

What is the Unique Device Identification (UDI) system?

The UDI system requires the labeling of medical devices with a unique identifier.

How do I ensure compliance with FDA cybersecurity requirements?

Importers must implement secure communication protocols and conduct vulnerability testing to ensure compliance with FDA cybersecurity requirements.