Verified 2026 Japan Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: South Korea to Japan

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

HTS Code9018.90

Why Customs Classification Matters for Medical Devices

Importing medical devices from South Korea to Japan poses significant compliance challenges. The primary issue is navigating the complex regulatory framework, which includes adherence to Japan's Pharmaceutical and Medical Devices Act (PMD Act) and the Medical Device Regulations. Additionally, importers must comply with labeling and packaging requirements, such as Japanese language labeling and proper packaging to prevent damage during transportation. The lack of harmonization between South Korea's and Japan's regulatory frameworks can lead to confusion and potential non-compliance, resulting in costly delays or even rejection of shipments. Furthermore, the COVID-19 pandemic has introduced new challenges, such as increased scrutiny of medical device imports and stricter border controls.

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
VAT/GST	20%	USD 3547.95
Total Landed Cost	—	USD 21287.70

Step-by-Step Import & Compliance Guide

To navigate the complex regulatory landscape and ensure successful importation of medical devices from South Korea to Japan, importers can follow a step-by-step guide. First, exporters must register their medical devices with Japan's MHLW and obtain the necessary certifications. Next, importers must ensure compliance with labeling and packaging requirements, including Japanese language labeling and proper packaging. Importers must also comply with tax and tariff regulations, including the JKFTA tariff rates, and maintain accurate records of device production, distribution, and maintenance. Finally, importers must stay up-to-date with the latest regulatory changes and updates, such as those related to the COVID-19 pandemic, to ensure continued compliance and avoid costly delays or rejection of shipments.

How Much Does It Cost to Import Medical Devices into Japan?

When importing Medical Devices from South Korea to Japan, the applicable customs duty rate is 8.5% on the CIF value (Cost + Insurance + Freight). Additionally, a VAT/GST of 20% 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 Japan.

HS Code 9018.90 — Customs Classification for Medical Devices

Medical Devices is typically classified under HS Code 9018.90 when imported into Japan. 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 Japan, a certificate of origin may qualify your goods for preferential (reduced) duty rates.

Frequently Asked Questions

What are the primary regulations governing medical device imports from South Korea to Japan?

The primary regulations include Japan's Pharmaceutical and Medical Devices Act (PMD Act) and the Medical Device Regulations.

What is the Japan-Korea Free Trade Agreement (JKFTA) tariff rate for medical devices?

The JKFTA tariff rate for medical devices, such as surgical instruments and orthopedic implants, is 0%.

What is the Unique Device Identification (UDI) system, and how does it apply to medical device imports from South Korea to Japan?

The UDI system requires the assignment of a unique identifier to each medical device, which must be submitted to Japan's MHLW database.

What are the labeling and packaging requirements for medical devices imported from South Korea to Japan?

Labeling and packaging requirements include Japanese language labeling and proper packaging to prevent damage during transportation.

How can importers stay up-to-date with the latest regulatory changes and updates for medical device imports from South Korea to Japan?

Importers can stay up-to-date by regularly checking Japan's MHLW website and consulting with regulatory experts.