Verified 2026 European Union Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: Brazil 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

Importing medical devices from Brazil to the EU poses significant compliance challenges. The EU has stringent regulations, including the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which require manufacturers to demonstrate conformity with EU rules. 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 fines, product recalls, 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 1275.00
VAT/GST	20%	USD 3255.00
Total Landed Cost	—	USD 19530.00

Step-by-Step Import & Compliance Guide

To navigate the complex regulations, manufacturers can follow a step-by-step guide: 1) Determine the EU classification of the medical device, 2) Conduct a risk assessment and clinical evaluation, 3) Prepare a technical file and Declaration of Conformity, 4) Obtain CE marking and other required certifications, 5) Ensure compliance with EU labeling and packaging requirements, and 6) Establish a post-market surveillance system to monitor device performance and report adverse events.

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

When importing Medical Devices from Brazil 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 Brazil 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 Brazil and European Union, a certificate of origin may qualify your goods for preferential (reduced) duty rates.

Frequently Asked Questions

What is the EU's Medical Device Regulation (MDR)?

The MDR is a regulation that sets rules for the marketing and use of medical devices in the EU.

Do I need a CE marking to import medical devices into the EU?

Yes, a CE marking is required to demonstrate conformity with EU regulations.

What is the EU's tariff code for medical devices?

The EU's tariff code for medical devices is 9018-9022.

How do I comply with the EU's General Data Protection Regulation (GDPR) for medical devices?

Manufacturers must ensure that their devices comply with GDPR requirements for data protection and privacy.

What is the UKCA marking, and do I need it to export medical devices to the UK?

The UKCA marking is a UK-specific marking that replaces the CE marking for certain products, including medical devices, in the UK market.