Verified 2026 Germany Customs Data(View Sources)

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

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

HTS Code9018.90

Why Customs Classification Matters for Medical Devices

Importing medical devices from South Korea to Germany poses significant compliance challenges. The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) require strict adherence to guidelines. Additionally, the Korea-EU FTA necessitates understanding of tariff reductions and rules of origin. Non-compliance can result in costly delays, fines, or even product recalls. The complexity of regulations, coupled with the need for CE marking, ISO 13485 certification, and compliance with the EU's General Data Protection Regulation (GDPR) for data privacy, makes navigation of these regulations daunting for exporters.

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

A step-by-step approach to compliance involves first understanding the specific regulations applicable to the device, such as MDR or IVDR. Next, ensure the device meets EU safety and performance requirements. Conduct a conformity assessment and obtain the necessary CE marking. Register the device in the Eudamed database and appoint an EU authorized representative. Prepare technical documentation and ensure compliance with labeling and packaging requirements. Finally, stay updated with the latest regulatory changes and maintain ongoing compliance through post-market surveillance and vigilance reporting.

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

When importing Medical Devices from South Korea to Germany, 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 Germany.

HS Code 9018.90 — Customs Classification for Medical Devices

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

Frequently Asked Questions

What are the primary regulations for importing medical devices from South Korea to Germany?

The primary regulations include the EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), along with the Korea-EU FTA for tariff reductions.

Is CE marking required for medical devices imported to Germany from South Korea?

Yes, CE marking is mandatory for medical devices to be sold in the EU, indicating compliance with EU health, safety, and environmental protection legislation.

What are the tariff numbers for duty-free medical devices under the Korea-EU FTA?

Tariff numbers under HS codes 9018, 9019, and 9020 may qualify for duty-free treatment, depending on the specific product and compliance with rules of origin.

How does the EU's GDPR affect the import of medical devices from South Korea?

The GDPR impacts the import of medical devices by requiring manufacturers to ensure data protection compliance, particularly for devices that collect personal or sensitive data.

What is the role of the EU authorized representative in the import process?

The EU authorized representative acts on behalf of the non-EU manufacturer, ensuring compliance with EU regulations, including registration, vigilance, and post-market surveillance.