Brazil ANVISA Registration for FDA 510(k) Devices
Navigate Brazil's $7.3B medical device market with your existing FDA clearance
Already have FDA 510(k) clearance? Here's what you need to know:
Key Questions for Market Entry:
- • Can I use my FDA 510(k) data for ANVISA registration?
- • What's the timeline from FDA clearance to Brazil approval?
- • Do I need a Brazilian Registration Holder (BRH)?
- • Is Brazilian GMP (CBPF, often called BGMP) certification required for my device class?
Common Challenges:
- • Understanding Brazil's 4-class system vs FDA panels
- • INMETRO requirements for electrical devices
- • Portuguese translations and labeling requirements
- • Post-market surveillance obligations
How Pure Global Accelerates Your Brazil Market Entry
Leverage our proven expertise and local presence to navigate ANVISA registration efficiently
End-to-End ANVISA Registration
Pure Global serves as your Brazil Registration Holder (BRH) and manages the complete ANVISA registration process. Our team handles device classification, dossier compilation, and submission management to ensure successful market entry.
Leverage Your FDA 510(k) Data
We help you maximize the value of your existing FDA 510(k) clearance by identifying which test reports, clinical data, and documentation can be reused for ANVISA submission, reducing time and costs.
Complete Compliance Management
From Brazilian GMP (CBPF) certification and INMETRO requirements to Portuguese labeling and post-market surveillance, we ensure full compliance with Brazilian regulations throughout your product lifecycle.
Brazil Regulatory Affairs Team
Expert ANVISA Registration Services
Our Brazil services include:
- Device classification and regulatory pathway determination
- Brazilian Registration Holder (BRH) services
- Brazilian GMP (CBPF) certification and INMETRO coordination
- Technical dossier compilation and ANVISA submission
- Portuguese labeling and documentation translations
- Post-market surveillance and compliance support
Proven Track Record in Brazil
Our experience delivering successful ANVISA registrations
Meet Our Brazil Team
Our experienced Brazil regulatory affairs specialists guide you through every step of ANVISA registration
Janaina brings over 8 years of experience in Brazilian medical device regulations. She specializes in ANVISA registration processes, Brazilian GMP certification, and post-market surveillance compliance. Her expertise helps international manufacturers navigate Brazil's complex regulatory landscape efficiently.
Tatianne manages our Brazil operations and coordinates client projects from initial consultation through approval. With her deep understanding of local business practices and regulatory timelines, she ensures smooth communication and efficient project management for all Brazil market entries.
Marcelo leads our Brazil strategy with over 15 years in medical device regulatory affairs. He has successfully guided hundreds of international companies through ANVISA registration, from Class I notifications to complex Class IV submissions. His strategic oversight ensures optimal regulatory pathways and market entry success.
Typical Class III Timeline
Total: 14-20 months door-to-approval
Brazilian GMP (CBPF) Certification
MDSAP route recommended
INMETRO
Can run in parallel
Dossier Prep
Portuguese translations
ANVISA Review
Historical median
Step-by-Step Roadmap
Hand this roadmap to your regulatory team the moment a U.S.-cleared (510k) device becomes a Brazil project
Choose Your Brazilian Registration Holder (BRH)
Brazilian law requires every foreign manufacturer to work through a Brazilian Registration Holder (BRH) with CNPJ number and ANVISA AFE (Autorização de Funcionamento de Empresa).
- BRH becomes legal owner of registration
- Point of contact for vigilance reports and renewals
- Tip: Request back-to-back contract for future transfers
Confirm Risk Class Under RDC 751/2022
Brazil uses four classes that map closely to GHTF model but not always to FDA's panel rules.
- Class I, II: Notificação (1-60 days)
- Class III, IV: Registro (8-14 months)
- Re-run classification if specs change from 510(k) version
Secure Brazilian GMP (BGMP) Certification
Brazilian GMP (CBPF, often called BGMP) certification required for Class III & IV devices before ANVISA will register the product.
- ANVISA inspection route: ~R$63,000/site + on-site audit
- MDSAP certificate + desk review: 4-year certificate on paperwork review
- MDSAP route cuts 4-6 months from timeline
Check INMETRO Scope (Electrical/Active Devices)
Most electro-medical products under IEC 60601-1 need INMETRO safety certificate.
- Brazilian certification body (OCP) reviews CB reports
- Factory audit (can combine with ISO 13485/MDSAP)
- 5-year certificate validity
Compile Technical Dossier (Dossiê Técnico)
Rebuild 510(k) file in Portuguese using ANVISA templates.
- Administrative forms and authorizations
- Device description matching RDC 751 nomenclature
- Risk management report (ISO 14971)
- Bench/biocompatibility data (notarized & translated)
- Portuguese labeling and IFU
- UDI implementation plan (mandatory for Class IV from July 2025)
Electronic Petition & ANVISA Review
Submit dossier through ANVISA SEI/SGR portal and navigate review process.
- Pay GRU fee (Class III: ~R$34,000; Class II: ~R$1,000)
- ANVISA screening (30 days)
- Technical review with Q&A rounds
- Publication in Diário Oficial
Post-Approval Actions
Maintain compliance and prepare for ongoing obligations.
- Registration validity: 10 years (file renewal 6-12 months before expiry)
- BGMP renewal every 4 years (MDSAP) or 2 years (ANVISA-only)
- Import licensing through SISCOMEX
- Vigilance reporting within 10 days
- UDI carrier implementation per class-specific deadlines
Where Your 510(k) Helps – And Where It Doesn't
Understanding how to leverage your existing FDA clearance
Bench & Biocompatibility Data
Accepted if notarized & translated; can shorten dossier prep
FDA Inspection History
Not substitute for BGMP, but MDSAP certificate built on FDA audit counts
U.S. Labeling
Serves as basis, but must be fully translated with ANVISA-specific statements
Predicate Rationale
Not relevant; ANVISA looks at risk class and performance, not substantial equivalence
Quick Checklist ✅
Follow this sequence to keep your project on schedule
Ready to Start Your Brazil Registration?
Get expert guidance from Pure Global's Brazil regulatory specialists
Contact Our Brazil Experts
Schedule a consultation to discuss your specific device and regulatory pathway