Register Your Genetic Testing Device in Brazil
Sequencers, PCR systems, genetic diagnosticsโnavigate ANVISA's evolving molecular diagnostics requirements.
Free consultation โข No commitment required
30-365
Days to Market
500+
Devices Registered
60-80%
Cost Savings
10yr
Registration Validity
Genetic Testing Faces Rapidly Evolving Regulations
Specialized devices need specialized expertise
Emerging Regulations
Brazil's genetic testing regulations are evolving. Staying current with ANVISA requirements is challenging.
Data Handling Requirements
Genetic data privacy and handling requirements add complexity to standard IVD registration.
Clinical Validation Depth
Genetic tests require extensive analytical and clinical validation across diverse populations.
We Specialize in Medical Genetics Devices
Pure Global experts know your device category inside out
Deep Category Expertise
Next-generation sequencing platform registration
Technical Documentation Excellence
PCR and molecular diagnostic device expertise
Proven Registration Track Record
Genetic test kit registration and validation
Ongoing Compliance Support
Companion diagnostic device registration
How It Works
Free Consultation
Share your device details. We'll confirm classification, assess your documentation, and provide an exact quote.
Expert Dossier Preparation
Our regulatory specialists prepare your complete submission with deep specialty knowledge.
Submission & Management
We submit on your behalf and manage the entire review process, including deficiency responses.
Market Your Device
Receive your registration. Your device is legally marketable for 10 years.
Trusted by Leading Genetic Testing Companies
โPure Global helped us navigate Brazil's genetic testing requirements. Our NGS platform is now registered.โ
Dr. Michael Chen
Chief Scientific Officer, GenomeSeq Technologies
Transparent Pricing
Complete service, no hidden fees
Starting from
Starting from $2,000/year
Based on device class and complexitySave 60-80%
Ready to Register Your Genetic Testing Device?
Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.