Verified 2026 Canada Customs Data(View Sources)

Medical Devices Import Duty & Landed Cost: Brazil to Canada

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

HTS Code9018.90

Why Customs Classification Matters for Medical Devices

Importing medical devices from Brazil to Canada poses significant compliance challenges. The primary concern is ensuring that these devices meet the stringent regulations set by Health Canada, which includes compliance with the Medical Devices Regulations (SOR/98-282). Additionally, importers must navigate the complexities of the Canada-Brazil trade relationship, including tariffs and taxes. The lack of harmonization between Brazilian and Canadian regulatory frameworks can lead to confusion and potential non-compliance. Furthermore, the COVID-19 pandemic has introduced new challenges, including increased scrutiny of medical device imports and potential supply chain disruptions. Importers must also consider the requirements for labeling, packaging, and post-market surveillance, which can be time-consuming and costly if not managed properly.

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 complexities of importing medical devices from Brazil to Canada, importers should follow a step-by-step approach. First, they should conduct a thorough review of the Canadian Medical Devices Regulations and ensure that their devices meet all relevant requirements. Next, they should obtain the necessary licenses and permits, including a Medical Device Establishment License (MDEL) and an Import Permit. Importers should also ensure that their devices are properly labeled and packaged, and that they meet all requirements for conformity assessment and certification. Finally, importers should consider working with a qualified regulatory consultant or trade compliance expert to ensure that they are meeting all relevant regulatory requirements and minimizing the risk of non-compliance.

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

When importing Medical Devices from Brazil to Canada, 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 Canada.

HS Code 9018.90 — Customs Classification for Medical Devices

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

Frequently Asked Questions

What are the primary regulations governing the import of medical devices from Brazil to Canada?

The primary regulations governing the import of medical devices from Brazil to Canada are the Medical Devices Regulations (SOR/98-282) and the Canadian Medical Devices Regulations.

Do medical devices imported from Brazil to Canada require certification?

Yes, medical devices imported from Brazil to Canada require certification, including ISO 13485:2016 certification and conformity assessment.

What are the labeling and packaging requirements for medical devices imported from Brazil to Canada?

Medical devices imported from Brazil to Canada must meet bilingual labeling and packaging requirements, including instructions for use.

Are there any tariffs or taxes applicable to the import of medical devices from Brazil to Canada?

Yes, there may be tariffs or taxes applicable to the import of medical devices from Brazil to Canada, including the Canada-Brazil General Preferential Tariff (GPT) and the Mercosur-Canada Free Trade Agreement.

Can I import medical devices from Brazil to Canada without a license or permit?

No, importers must obtain the necessary licenses and permits, including a Medical Device Establishment License (MDEL) and an Import Permit, to import medical devices from Brazil to Canada.