Verified 2026 United States Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: Vietnam 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 Vietnam to the US can be complex due to stringent regulations. The FDA requires compliance with its standards, and non-compliance can result in costly delays or even product seizures. Additionally, the US has specific tariffs and taxes on medical devices, with some products subject to a 2.5% duty rate under the Harmonized Tariff Schedule (HTS). Ensuring compliance with US regulations, such as registration with the FDA and obtaining necessary certifications like ISO 13485, is crucial for successful importation.

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 import regulations for medical devices from Vietnam, follow these steps: 1) Register your device with the FDA, 2) obtain necessary certifications, such as ISO 13485, 3) accurately classify your product under the HTS, 4) comply with FDA standards, including design controls and labeling requirements, and 5) maintain detailed records. Working with a qualified regulatory consultant can help navigate the complex regulatory landscape and ensure successful importation of your medical devices.

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

When importing Medical Devices from Vietnam 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 Vietnam 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 Vietnam 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 imported from Vietnam?

The FDA registration process involves submitting a pre-market notification (510(k)) or pre-market approval (PMA) application, depending on the device's classification.

What are the tariff numbers for medical devices imported from Vietnam to the US?

Tariff numbers for medical devices vary, but examples include 9018.39.00 for medical instruments and 9021.21.00 for orthopedic appliances.

Do medical devices imported from Vietnam require ISO 13485 certification?

Yes, ISO 13485 certification is often required for medical devices imported from Vietnam, as it demonstrates compliance with international quality management standards.

How do I classify my medical device under the Harmonized Tariff Schedule (HTS)?

Classification under the HTS involves identifying the correct tariff number based on the device's characteristics, function, and materials.

What are the labeling requirements for medical devices imported from Vietnam to the US?

Labeling requirements include compliance with FDA regulations, such as 21 CFR Part 801, and may involve providing instructions for use, warnings, and other relevant information.