Verified 2026 United States Customs Data(View Sources)

Pacemakers Import Duty & Landed Cost: Japan to United States

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

HTS Code9021.50

Why Customs Classification Matters for Pacemakers

Classifying pacemakers correctly under import regulations for pacemakers from Japan to US 2026 is a complex task due to the strict US FDA requirements for pacemakers imported from Japan. Failure to comply with these regulations, including obtaining the correct HTS code for pacemakers shipped from JP to US, can result in significant delays or even rejection of shipments. Moreover, understanding the duty rates for medical devices from Japan to US is crucial to avoid unexpected costs. As Class III medical devices, pacemakers are subject to rigorous medical device regulations, making it essential to follow a compliance checklist for exporting pacemakers to US to ensure smooth US customs clearance for pacemakers from Japan.

Cost Breakdown

Component	Rate	Amount
Product Value	—	USD 5000.00
Shipping	—	USD 800.00
Insurance	—	USD 50.00
CIF Value	—	USD 5850.00
Customs Duty	10.5%	USD 614.25
Merchandise Processing Fee (MPF)Min $31.67, Max $614.35	0.3464%	USD 31.67
Harbor Maintenance Fee (HMF)	0.125%	USD 7.31
VAT/GST	N/A (state sales tax varies)	USD 0.00
Total Landed Cost	—	USD 6503.23

Step-by-Step Import & Compliance Guide

To successfully import pacemakers into the US from Japan, a step-by-step approach is necessary. First, ensure all products are correctly classified with the appropriate HTS code for pacemakers shipped from JP to US. Next, verify that all US FDA requirements for pacemakers imported from Japan are met, including necessary certifications and compliance with medical device regulations. It's also important to consider duty rates for medical devices from Japan to US and whether pacemakers qualify for any duty exemptions under the US-Japan trade agreement. Documents such as commercial invoices, bills of lading, and certificates of origin will be required. Importers should also be aware of the de minimis threshold of $800 USD under the US-Japan Trade Agreement and how it might apply to their shipments, potentially reducing or eliminating duty payments.

How Much Does It Cost to Import Pacemakers into United States?

When importing Pacemakers from Japan to United States, the applicable customs duty rate is 10.5% 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 Japan and United States.

HS Code 9021.50 — Customs Classification for Pacemakers

Pacemakers is typically classified under HS Code 9021.50 when imported into United States. At this classification, the customs duty rate is 10.5%. 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 Japan and United States, a certificate of origin may qualify your goods for preferential (reduced) duty rates.

Frequently Asked Questions

What are the FDA clearance requirements for pacemakers imported from Japan?

FDA clearance for pacemakers involves meeting specific US FDA requirements for pacemakers imported from Japan, including premarket approval.

Do pacemakers qualify for duty exemptions under US-Japan trade agreements?

Pacemakers may qualify for reduced tariffs under the US-Japan Framework for Promoting Economic Cooperation, impacting duty rates for medical devices from Japan to US.

What is the duty rate for importing pacemakers from Japan to the US?

The duty rate for pacemakers is 10.5%.

What documents are required for importing pacemakers from Japan to the US?

Required documents include commercial invoices, bills of lading, and certificates of origin, ensuring compliance with US customs clearance for pacemakers from Japan.

Are there any tax exemptions or special programs for importing pacemakers?

The US-Japan Trade Agreement offers a de minimis threshold of $800 USD, and the US-Japan Framework for Promoting Economic Cooperation may provide reduced tariffs for certain medical devices.