OPERON ELEVATEPLUS | ANVISA
ANVISA Medical Device Registration Services in Brazil
Expanding into Latin America’s largest healthcare market requires navigating strict ANVISA medical device regulations. To commercialize products in Brazil, foreign and local manufacturers must secure ANVISA approval through the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária).
Operon Strategist delivers end-to-end consulting for ANVISA medical device registration in Brazil. From risk classification and Brazilian Registration Holder (BRH) appointment to B-GMP compliance and INMETRO certification, our experts streamline your pathway to market access.
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Operon ElevatePlus
ANVISA Medical Device Registration Service Portfolio
ANVISA Device Classification & Regulatory Strategy
Precise ANVISA medical device classification across Class I, II, III, and IV based on risk rules
Pathway selection (Notification vs. Registration) Strategic product grouping
Strategic product grouping to optimize submission fees and submission timelines
Brazilian Registration Holder (BRH) Representation
Independent Brazilian Registration Holder services to foreign entities without a physical base in Brazil
Direct liaison with ANVISA
Post-market surveillance & technovigilance
Technical Documentation & Dossier Preparation
Technical file assembly structured according to current ANVISA Brazil dossier frameworks
Portuguese translation & localization
Labeling & IFU compliance review
Brazilian Good Manufacturing Practice (B-GMP) Compliance
Gap analysis and implementation of quality management standards aligned with ANVISA RDC 665 / RDC 665:2022
Inspection readiness preparation for ANVISA facility audits (mandatory for Class III and IV devices)
CAPA development, audit remediation, and leveraging Medical Device Single Audit Program (MDSAP) reports
INMETRO Certification Assistance & Coordination
Scope evaluation for electro-medical devices subject to mandatory INMETRO certification (IEC 60601 family)
Coordination with accredited local and international testing laboratories to manage testing workflows
Integration of INMETRO marks and test certificates into the final ANVISA submission dossier
Submission, Review, and Market Authorization Support
Complete management of electronic dossier filings via ANVISA portal systems
Agency query resolution
Gazette approval tracking
Quality Management System (QMS) Alignment (ISO 13485 and Global Compliance)
Mapping existing ISO 13485 QMS processes to meet specific B-GMP requirements
Utilization of MDSAP audit reports to streamline B-GMP certification
Post-market SOP updates to maintain ongoing ANVISA compliance across product lifecycles
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
Deep specialization across ANVISA medical device regulations and Latin American market entry routes
Independent BRH Services ensuring foreign manufacturers retain full control over their registration and distributors
Seamless Integration of INMETRO testing standards and B-GMP requirements into your regulatory pathway
Proven track record of accelerating ANVISA approvals for startups, SMEs, and global medical technology leaders
Regulatory Strategy & Implementation – We design, compile, and optimize regulatory submissions for medical device organizations to meet ANVISA’s strict expectations. Our approach addresses common audit and submission gaps, integrates local Brazilian requirements with your existing technical data, and enables a smooth transition from dossier preparation to market authorization, ensuring sustained compliance and commercial success in Brazil.
Operon ANVISA Registration Advantage
End-to-end ANVISA regulatory strategy, dossier submission, and compliance support tailored to meet Brazil’s strict medical device safety, quality, and performance standards.
Strategic leverage of MDSAP audit findings for fast-track quality approvals
Simplify ANVISA compliance and accelerate Brazilian market entry.
Expert regulatory guidance for fast Brazilian market access.
Accelerate your medical device approval in the Brazilian market.
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frequently asked questions
Why is ANVISA registration necessary to sell medical devices in Brazil?
ANVISA medical device registration is a mandatory legal requirement enforced by the National Health Surveillance Agency. It ensures that medical equipment and IVDs distributed in Brazil meet national standards for safety, efficacy, and quality.
Do foreign manufacturers need a local representative in Brazil?
Yes. Foreign manufacturers without a registered office in Brazil must appoint an independent Brazilian Registration Holder (BRH). The BRH holds the product registration certificate, acts as the regulatory liaison with ANVISA, and oversees local post-market duties.
What is the difference between ANVISA Notification and Registration?
Notification (Notificação): Applies to low-risk devices (Class I and Class II) with a simplified review process and no expiration date.
Registration (Registro): Mandatory for higher-risk devices (Class III and Class IV), requiring a thorough technical review, B-GMP certification, and renewal every 10 years.
What is the role of INMETRO certification in Brazil?
INMETRO certification is mandatory for electro-medical equipment to verify compliance with electrical safety and electromagnetic compatibility (EMC) standards. ANVISA requires valid INMETRO certification before granting final product approval.
How does B-GMP compliance impact medical device registration?
Manufacturers of Class III and Class IV devices must obtain Brazilian Good Manufacturing Practice (B-GMP) certification under RDC 665. ANVISA verifies compliance through physical facility inspections or by reviewing qualifying MDSAP audit reports.
Navigate ANVISA Registration and B-GMP Certification in Brazil Without Regulatory Delays
Talk to an ANVISA Medical Device Registration Consultant