Register Your Class II Device in Brazil in 30-60 Days
Navigate ANVISA's moderate-risk requirements with confidence. We handle technical dossiers, GMP compliance, and local representation.
Free consultation โข No commitment required
30-60
Days to Market
500+
Devices Registered
60-80%
Cost Savings
10yr
Registration Validity
Why Companies Struggle with Brazil Registration
Specialized devices need specialized expertise
Everything Must Be in Portuguese
Technical dossiers, labels, instructionsโall documents must be professionally translated. One error can trigger rejection.
Consultants Charge $8,000-$20,000
Traditional regulatory consultants charge premium fees with hidden costs that appear mid-project.
You Need a Local Brazil Presence
ANVISA requires a Brazil Registration Holder (BRH). Without one, you cannot legally sell in Brazil.
We Simplify Class II Registration
Pure Global experts know your device category inside out
Deep Category Expertise
Our regulatory specialists prepare ANVISA-compliant technical dossiers. We know exactly what ANVISA expects.
Technical Documentation Excellence
We review your manufacturing documentation and identify gaps before submissionโavoiding costly rejections.
Proven Registration Track Record
Our systematic approach gets Class II devices registered in 30-60 days. We've done this 500+ times.
Ongoing Compliance Support
As your Brazil Registration Holder, we're not tied to any distributor. Your registration, your control.
How It Works
Free Consultation
Share your device details. We'll confirm classification, review your documentation readiness, and provide an exact quote.
Dossier Preparation
We prepare your complete technical dossierโtranslated, formatted, and organized to ANVISA standards.
ANVISA Submission & Follow-up
We submit on your behalf, handle all ANVISA queries, and keep you updated throughout the review process.
Market Your Device
Receive your ANVISA registration. Your Class II device is legally marketable in Brazil for 10 years.
Trusted by Leading MedTech Companies
โPure Global navigated our Class II registration flawlessly. They handled everything from dossier prep to ANVISA follow-up. Registered in just 4 months.โ
Michael Torres
VP Regulatory Affairs, Precision Medical Systems
Class II Investment
Complete service, no hidden fees
Starting from
$2,000/year
$8,000-$20,000 with traditional consultantsSave 60-80%
Ready to Register Your Class II Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.