Verified 2026 European Union Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: South Korea to European Union

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

HTS Code9018.90

Why Customs Classification Matters for Medical Devices

The import of medical devices from South Korea to the EU poses significant compliance challenges. The EU's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) impose stringent requirements on device manufacturers, including conformity assessments, clinical evaluations, and post-market surveillance. Additionally, the EU's General Data Protection Regulation (GDPR) and the Medical Device Single Audit Program (MDSAP) must be considered. Non-compliance can result in costly delays, fines, and damage to a company's reputation.

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 ensure compliance with EU regulations, manufacturers should follow a step-by-step approach. First, they should conduct a thorough review of the EU's MDR and IVDR to understand the requirements. Next, they should identify the necessary certifications and approvals, including the CE mark and any relevant harmonized standards. Manufacturers should also establish a quality management system, such as ISO 13485, and ensure that their devices meet the EU's essential requirements. Finally, they should work with a qualified Notified Body to conduct conformity assessments and obtain the necessary certifications.

How Much Does It Cost to Import Medical Devices into European Union?

When importing Medical Devices from South Korea to European Union, 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 European Union.

HS Code 9018.90 — Customs Classification for Medical Devices

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

Frequently Asked Questions

What are the EU's customs regulations for importing medical devices from South Korea?

The EU's customs regulations for importing medical devices from South Korea include the Union Customs Code (UCC) and the Authorized Economic Operator (AEO) program.

What is the CE mark and how is it obtained?

The CE mark is a certification that indicates a medical device meets the EU's essential requirements. It is obtained through a conformity assessment by a qualified Notified Body.

What are the EU's tariff codes for medical devices?

The EU's tariff codes for medical devices include 90.18 for medical instruments and 90.20 for diagnostic instruments.

What is the EU-Korea Free Trade Agreement (EKFTA) and how does it affect medical device imports?

The EKFTA provides tariff reductions and eliminations for certain medical devices imported from South Korea to the EU.

What is the role of a Notified Body in the conformity assessment process?

A Notified Body is an independent third-party organization that conducts conformity assessments and issues certifications, such as the CE mark, to indicate that a medical device meets the EU's essential requirements.