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Medical Device Distribution in Brazil with a Compliant, Execution-Ready Partner

Q: Can you support ANVISA registration for medical devices?

We support the registration pathway planning, technical file coordination, and Responsável Técnico alignment required for ANVISA submissions. The registration process is sequenced alongside operational planning so your import and commercial launch timelines remain consistent throughout.

Q: Can we bring equipment to Brazil before ANVISA registration is complete?

Yes, in specific cases. We structure temporary import for demonstration (Admissão Temporária) for medical and aesthetic equipment — allowing clinical evaluations, trade show participation, and market validation before your permanent ANVISA registration is in place. This approach reduces the financial and operational risk of committing to a full import before the market is proven.

Q: Can we start with a small initial stock before scaling?

Yes. Many healthcare companies start with a small initial stock — pilot units for clinical evaluation, demo equipment for the sales team, and a first commercial batch for early accounts. The operation scales as demand becomes more predictable. You do not need to commit to large volumes before you have market validation.

Novatrade supports medical device manufacturers, aesthetic technology brands, and healthcare equipment companies entering Brazil. We manage ANVISA compliance pathways, import operations, warehousing, and distribution so you can focus on commercial growth.

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Why Brazil is Complex for Medical Devices

Brazil is one of the largest healthcare markets in Latin America. Hospital networks, surgical centers, dermatology clinics, and aesthetic medicine practices generate consistent demand for imported technology. But ANVISA registration requirements, complex import procedures, and a fragmented distribution landscape create real barriers for companies without a local operational structure.
Novatrade removes this complexity with a ready-to-use importer and distribution model designed for international healthcare companies.

Why We Stand Out:

We manage ANVISA compliance end-to-end

Registration pathways, technical documentation, and import sequencing handled by specialists.

We provide a fully operational import structure from day one

Customs clearance, bonded warehouse, and nationwide distribution without building a local entity.

We maintain local stock in São Paulo

Demo units reach clinics and hospitals faster, shorter lead times, shorter sales cycles.

You keep full commercial control

Novatrade handles the operational and regulatory infrastructure your product needs to sell in Brazil.

Our Partner Brands

Through Harmonie, Novatrade distributes international medical aesthetic and healthcare brands across Brazil. Each brand in the portfolio operates with a dedicated distribution plan, regulatory compliance support, and consistent commercial execution across dermatology clinics, aesthetic medicine practices, and healthcare institutions.

MEDICAL AESTHETICS · FRANCE

LPG Group

Skin rejuvenation and body contouring devices

French pioneer in non-invasive body and face treatment, with over 38 years of clinical expertise. LPG technology is used by more than 28,000 professionals worldwide, present in aesthetic medicine and dermatology clinics across Brazil.

Clinic Distribution

ANVISA-Registered

MEDICAL AESTHETICS · SOUTH KOREA

Hironic

Laser devices for dermatology and aesthetics

South Korean manufacturer of laser and energy-based devices for medical aesthetics. Present in over 60 countries, Hironic equipment is used by dermatologists and aesthetic medicine physicians with a focus on clinically documented results.

Medical Device Import

ANVISA-Registered

AESTHETIC MEDICINE · BRAZIL

Hialurox

Hyaluronic acid dermal fillers

Brazilian manufacturer of cross-linked hyaluronic acid fillers, GMP-certified, with over 50,000 applications per year. Distributed to aesthetic clinics and licensed medical professionals across the country.

Clinic Distribution

50,000+
Applications
Per Year

How It Works

A typical engagement follows a clear sequence designed to reduce regulatory risk and shorten time-to-market. Each step builds on the previous — no wasted moves, no surprises at customs.

Feasibility Assessment

ANVISA device classification, import model definition, and regulatory timeline mapped to your specific product and commercial objectives.

ANVISA Registration Plan

Registration roadmap built and aligned with operational readiness — so compliance milestones and your commercial launch timeline move together.

Import and Logistics Planning

Incoterms, HS/NCM classification, applicable taxes, and ANVISA import license requirements defined before the first shipment. No surprises at customs.

First Shipment or Demo Import

Permanent commercial import or temporary import for demonstration — chosen based on your registration status, clinical objectives, and market validation goals.

Warehousing and Inventory Setup

Local stock configured for your product — small initial batches for clinical pilots, demo units for the sales team, and replenishment stock for active accounts.

Distribution Execution

Orders processed, tracked, and delivered to hospitals, surgical centers, and clinics with Notas Fiscais issued and service levels expected in B2B healthcare operations.

Commercial Acceleration

Your sales team and distribution partners activated to convert operational availability into growing revenue — with inventory and logistics fully managed by Novatrade.

Who This Is For

If you are a foreign company ready to distribute medical devices, aesthetic technology, or healthcare equipment in Brazil, Novatrade acts as your operational partner on the ground. We manage ANVISA compliance, import execution, warehousing, and distribution for you, so you can focus on building your market. One point of contact. No local subsidiary needed.

medical device distribution in brazil with a compliant execution ready partner

Medical Device Manufacturers

European manufacturers of surgical instruments, diagnostic equipment, patient monitoring systems, or hospital technology that need ANVISA-compliant import and distribution to reach Brazilian hospitals and surgical centers.

Aesthetic Technology Brands

Companies commercializing body contouring, skin rejuvenation, laser, or energy-based devices for dermatology and aesthetic medicine practices — reaching Brazil’s large and growing aesthetic clinic network.

Healthcare Equipment Companies

Manufacturers of rehabilitation equipment, dental technology, ophthalmic devices, or physiotherapy systems looking to reach Brazilian healthcare institutions, clinics, and specialty practices without establishing a local entity.

Our Services

ANVISA product classification and registration pathway definition — medical devices (Class I to IV), IVD equipment, and aesthetic technology products handled according to RDC 751/2022 and applicable regulations.
Technical file preparation and coordination with the responsible technical manager (Responsável Técnico) required for registration submission — reducing delays from documentation gaps.
Go-to-market sequencing built around registration milestones — so your first import shipment and commercial launch are aligned from the start, not scrambled after approval.
Post-registration compliance support: labeling requirements in Portuguese, product recalls protocol, and periodic renewal management to keep your ANVISA status active.

Full import operation management under Novatrade’s RADAR-registered structure — customs clearance, import documentation (DI/DUIMP), tax calculation, and delivery execution with no local subsidiary required.
Bonded warehouse and local inventory management in São Paulo — including controlled-temperature storage when required for sensitive medical or aesthetic products.
Order processing, fulfillment, and distribution to hospitals, surgical centers, dermatology clinics, and aesthetic medicine practices — with Notas Fiscais issued and operational reporting for forecasting.
ICMS tax optimization through Novatrade’s Santa Catarina structure, reducing the landed cost of high-value medical equipment shipments.

Learn more about our Import and Distribution Services

Channel strategy and distributor outreach — identifying and activating the right commercial partners for your device category, whether hospitals, specialty clinics, or aesthetic medicine networks.
Import and stock operations managed by Novatrade while your team runs prospecting, key account management, and clinical relationships — clean separation of roles, no overlap.
Commercial execution through Novatrade’s structure when a full in-market sales presence is needed — without the cost and compliance burden of opening a Brazilian subsidiary.
Ex-Tarifário (import duty exemption) support for qualifying medical equipment — improving your price competitiveness before the first commercial shipment arrives.

Temporary import for demonstration (Admissão Temporária) structured for medical and aesthetic equipment — bringing your device into Brazil for clinical evaluations, congresses, and product validation without the cost of a permanent import.
Support for exhibition at Brazilian healthcare trade shows — HOSPITALAR, FISIOTERAPIA & SAÚDE, and ABIMO events — including import logistics and re-export coordination after the event.
Market validation before full ANVISA registration is in place — allowing clinical feedback and commercial traction while the registration process runs in parallel.
Full customs and documentation management for the temporary regime — deadlines, extensions, and re-export compliance handled so your team focuses on the clinical or commercial objectives of the visit.

Learn more about Temporary import for demonstration

Client’s Success Stories

Entering the Brazilian healthcare market requires more than a product. Axium MTech shows what compliant, structured market entry looks like in practice.

AXIUM MTech

Challenge: AXIUM MTech, a provider of medical devices, was distributing its products in Brazil via Nestlé. As Nestlé decided to refocus solely on its nutrition business, AXIUM needed to shift importation and distribution responsibilities—without disrupting hospital supply chains.

Solution: Novatrade assumed full responsibility for regulatory-compliant importation, inventory management, and national distribution. Nestlé retained its sales force to maintain customer relationships, while Novatrade ensured seamless logistics and operational support. Novatrade also manages the deployment and oversight of medical pumps in hospitals and clinics.

Outcome: AXIUM secured a stable, scalable distribution model in Brazil with uninterrupted service, while Nestlé continued to lead sales efforts—ensuring product availability and customer satisfaction across the healthcare sector.

Frequently Asked Questions

No. Novatrade acts as your Importer of Record in Brazil, holding the legal responsibility for import, customs clearance, and distribution. You operate through our structure — no CNPJ, no local payroll, no subsidiary required before you have proven commercial traction in the market.

We support the registration pathway planning, technical file coordination, and Responsável Técnico alignment required for ANVISA submissions. The registration process is sequenced alongside operational planning so your import and commercial launch timelines remain consistent throughout.

Yes, in specific cases. We structure temporary import for demonstration (Admissão Temporária) for medical and aesthetic equipment — allowing clinical evaluations, trade show participation, and market validation before your permanent ANVISA registration is in place. This approach reduces the financial and operational risk of committing to a full import before the market is proven.

Our distribution reach covers hospitals, surgical centers, dermatology clinics, aesthetic medicine practices, physiotherapy centers, and dental clinics — depending on your device category and target segment. We adapt the channel strategy to your product and commercial objectives.

That works well. Novatrade handles import, ANVISA compliance, warehousing, and distribution logistics while your team focuses on key account management, clinical relationships, and commercial prospecting. Clean separation of roles — your commercial control stays intact.

Yes. Many healthcare companies start with a small initial stock — pilot units for clinical evaluation, demo equipment for the sales team, and a first commercial batch for early accounts. The operation scales as demand becomes more predictable. You do not need to commit to large volumes before you have market validation.

Distribute Your Medical Device in Brazil

If you manufacture medical devices, aesthetic technology, or healthcare equipment and want a compliant, execution-ready way to enter Brazil, we can map the right model for your product. Talk to our team and request a feasibility assessment.