Verified 2026 Germany Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: Brazil 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 Brazil 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 Brazilian regulatory framework, including ANVISA, must be navigated. Compliance with these regulations is crucial to avoid costly delays, fines, or even product recalls. The complexity of these regulations can be overwhelming, especially for companies new to international trade. Understanding the specific requirements for medical devices, such as CE marking, ISO 13485 certification, and conformity assessment procedures, is essential for a smooth import process.

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 ensure compliance with Brazil to Germany medical devices import regulations, companies should follow a step-by-step approach. First, determine the relevant HS code and tariff rate for the product. Next, obtain necessary certifications, such as CE marking and ISO 13485. Register with EUDAMED and comply with GDPR. Conduct a thorough risk assessment and ensure that products meet EU essential requirements. Finally, prepare a Declaration of Conformity and Certificate of Free Sale, if required. By following these steps, companies can ensure a smooth and compliant import process.

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

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

Frequently Asked Questions

What is the Harmonized System (HS) code for medical devices?

The HS code for medical devices is 9018.39.00.

Do I need to register with the European Database on Medical Devices (EUDAMED)?

Yes, registration with EUDAMED is required for companies importing medical devices into the EU.

What is the tariff rate for medical devices under the EU-Mercosur trade agreement?

The tariff rate for medical devices under the EU-Mercosur trade agreement is 0%.

Is ISO 13485 certification required for medical devices?

Yes, ISO 13485 certification is a key requirement for demonstrating a company's ability to maintain a quality management system.

Do I need to comply with the EU's General Data Protection Regulation (GDPR)?

Yes, companies importing medical devices into the EU must comply with GDPR.