ANVISA Brazil Medical Device Registration & BGMP Services
Your Partner for Compliance, Registration and Sustainable Market Access in Brazil
End-to-end regulatory, technical and compliance support for Medical Devices, IVDs, Software and Accessories to achieve ANVISA registration, BGMP certification and long-term compliance in Brazil.
Deep ANVISA Regulatory Expertise
Experienced team with successful ANVISA approvals
High Approval Success Rate
Proven strategies for faster market access
BGMP Specialists You Can Rely On
End-to-end BGMP implementation & certification support
Strong Lab Network in Brazil
Access to ANVISA-recognized testing laboratories
End-to-End Support
From strategy to registration, compliance & post-market
Our Brazil Regulatory Services
1. ANVISA Regulatory Strategy & Classification
- •Determine correct risk class (Classes I, II, III, IV)
- •GMDN term validation & technical name
- •Regulatory pathway assessment (Cadastro or Notificação)
- •Gap assessment against RDC 751/2022 & RDC 665/2022
2. Product Registration (Cadastro) & Notificação
- •Dossier preparation & submission via Solicita
- •Cadastro (for Classes II, III, IV) & Notificação (Class I)
- •Response to exigências (ANVISA queries)
- •Follow-up until final deferimento (approval)
3. BGMP Compliance & Certification
- •BGMP implementation (RDC 665/2022)
- •Internal audits & gap assessments
- •Documentation & SOP development
- •Pre-inspection readiness & ANVISA inspection support
4. Technical Documentation & Brazilian Compliance
- •Technical file preparation as per RDC 751/2022 & 848/2024
- •Essential Principles checklist mapping
- •Risk Management (ISO 14971)
- •Usability, IFU, labeling & package compliance
5. Testing Strategy & Laboratory Coordination
- •Define testing plan based on risk & intended use
- •Coordination with ANVISA-recognized labs in Brazil
- •STED, MET, EMC, Biocompatibility, Sterilization, Packaging
- •Test report review & compliance assessment
6. ANVISA Application Audit & Support
- •Application dossier review before submission
- •Mock audit & gap remediation
- •Response strategy for ANVISA technical exigências
- •Dossier optimization for faster approval
7. IVD Registration & Performance Evidence
- •IVD classification (Classes I to IV under RDC 830/2023)
- •Analytical performance studies
- •Clinical performance evaluation
- •Performance report as per RDC 830/2023
8. SaMD / Software / AI & Cybersecurity
- •Software classification (RDC 657/2022)
- •IEC 62304 & ISO 14971 compliance
- •Cybersecurity risk management
- •AI/ML algorithm validation & transparency
9. Labelling, IFU & Advertising Compliance
- •Portuguese labelling as per RDC 751/2022
- •IFU in Portuguese & e-labelling
- •Symbols & UDI requirements (RDC 591/2021 & SIUD)
- •Advertising & promotional material review
10. Post-Market Surveillance, Vigilance & Tecnovigilância
- •TECNOVIGILÂNCIA system registration & reporting
- •Incident reporting (Formulário de Tecnovigilância)
- •Trend analysis & CAPA
- •Recall, field safety corrective actions (FSCA)
11. Change Management & Variations
- •Assess impact of changes on registration
- •Prepare & submit change notifications
- •Update technical file, labelling & IFU
- •Lifecycle management support & revalidation
12. Importer & Legal Representative Services
- •Appointing Importer in Brazil (BRH)
- •Local legal representative coordination
- •ANVISA product registration ownership support
- •Supply chain compliance & AFE alignment
Our End-to-End Brazil Regulatory Process
Strategy & Qualification
Confirm product status, intended purpose, classification and Brazilian route.
Documentation Prep
Compile technical file, Essential Principles mapping, and Portuguese translations.
Testing & Evidence
Review safety/performance evidence, BGMP needs, and laboratory gaps.
Dossier & Submission
Compile notification/registration content and submit via Solicita.
ANVISA Review
Manage technical questions, exigências, and preliminary queries.
Response & Approval
Formulate rigorous technical responses leading to deferimento.
BGMP Certification
Manage CBPF certification and inspection readiness where applicable.
Post-Market & PMS
Maintain labeling, SIUD UDI, tecnovigilância, and change control.
ANVISA Registration Pathways by Risk Class
(Low Risk)
Notificação (Simplified)
- • No pre-market technical review of full dossier
- • Technical evidence maintained & available
- • Exempt from pre-market audit
(Moderate Risk)
Cadastro (Full Review)
- • Notification / Cadastro pathway
- • Dossier maintenance & post-market oversight
- • May be subject to pre-market audit
(High Risk)
Cadastro (Full Review + Audit Likely)
- • ANVISA technical review of dossier
- • BGMP / CBPF applies to manufacturing sites
- • Subject to pre-market audit (on-site)
(Highest Risk)
Cadastro (Full Review + Audit Mandatory)
- • Highest scrutiny on technical file & clinical data
- • BGMP / CBPF mandatory for manufacturing sites
- • Subject to pre-market audit (on-site)
About ANVISA
ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian Health Regulatory Authority responsible for regulating medical devices, IVDs and related products to ensure safety, efficacy and quality.
gov.br/anvisaBGMP Legal Framework
- • RDC 665/2022 - Medical Device GMP
- • RDC 751/2022 - Medical Device Framework
- • RDC 687/2022 - CBPF Certification
- • RDC 848/2024 - Safety & Performance
- • RDC 830/2023 - IVD Framework
Post-Market Obligations
- • Maintain TECNOVIGILÂNCIA system
- • Serious incidents: Immediate reporting
- • Other incidents: Up to 10 working days
- • Annual reports & trend analysis
- • Recall & FSCA execution support
Key Timelines (Indicative)
Respond to Exigências: Up to 10-30 working days
ANVISA Review: Up to 60-90 working days
ANVISA Audits
For Classes III & IV, ANVISA conducts pre-market audits. BGMP audit is required for Class III & IV and for foreign manufacturers without BGMP/MDSAP certification.
Why Choose NKB Regovanta for Brazil?
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Partner with our Brazil regulatory experts to achieve ANVISA registration, BGMP certification and sustainable market access.
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Success in Brazil
Comprehensive ANVISA Regulatory & BGMP Compliance
Explore our in-depth methodologies, strategic frameworks, and regulatory decision pathways for the Brazilian market.
1. ANVISA Regulatory Strategy & Product Classification
Correct classification is the foundation of the Brazilian submission. Under RDC 751/2022, medical devices are classified from Class I to IV according to risk. The classification determines whether the product follows notification or registration, the level of evidence expected, BGMP implications and the way changes will be controlled after market entry.
When This Is Needed
- • A new device or IVD is being introduced in Brazil
- • The intended use or claims differ from an existing global registration
- • The manufacturer is uncertain whether the product is a medical device, accessory, SaMD or IVD
- • A product family needs to be grouped appropriately for Brazilian regularization
- • An existing classification may be affected by a design, software or intended-use change
Our Support Includes
- • Product qualification and regulatory status assessment
- • Intended purpose, indications and claims review
- • Class I-IV classification under RDC 751/2022
- • IVD classification under RDC 830/2023
- • Accessory and system/family considerations
- • Brazilian technical-name and grouping strategy
- • Notification versus registration pathway assessment
- • Initial BGMP/CBPF applicability assessment
What We Challenge Before Submission:
Does the intended use support the proposed risk class, and does the Brazilian technical name align with the device actually being marketed?
2. ANVISA Notification & Registration
ANVISA uses different pre-market routes according to risk. Class I and II devices generally follow notification, while Class III and IV devices require registration and technical review. The submission must be consistent across the application form, legal manufacturer, Brazilian holder, intended use, models, technical name, classification, labeling and supporting evidence.
When This Is Needed
- • Launching a Class I-IV medical device in Brazil
- • Transferring or restructuring a product portfolio under a Brazilian registration holder
- • Adding models, configurations or family members
- • Moving from an older Brazilian authorization structure to the current regulatory framework
Our Support Includes
- • Notification strategy for Class I and II devices
- • Registration strategy for Class III and IV devices
- • Application and petition planning in Solicita
- • Technical dossier compilation (RDC 751/2022)
- • Legal manufacturer and Brazilian holder data alignment
- • Declarations and authorization documentation
- • Labeling/IFU package review & translation strategy
- • ANVISA technical query and exigência response support
What We Challenge Before Submission:
Is the selected petition code correct, and do the model list and commercial configurations match the technical dossier?
3. Brazil Registration Holder & Local Regulatory Interface
Foreign manufacturers require a legally established Brazilian entity to hold the ANVISA notification or registration and interface with the Agency. The local holder is more than an address: it is central to submissions, changes, importation coordination, post-market reporting, field actions and access to the technical documentation that supports the product.
Our Support Includes
- • Brazilian holder readiness assessment
- • Manufacturer-holder quality and regulatory interface
- • Authorization documentation and power-of-attorney coordination
- • AFE and activity-scope alignment checks
- • Technical documentation access expectations
- • Complaint and adverse-event escalation process
- • Field-action and recall communication pathway
- • Change-notification governance & import support
What We Challenge Before Submission
- • Who owns the master regulatory data and approved Brazilian labeling?
- • How quickly must the manufacturer notify the holder of design, supplier, site or software changes?
- • Can the holder access investigation and safety information when ANVISA requests it?
- • Are complaint, vigilance and field-action responsibilities contractually clear?
- • Does the holder identity match the labeling and ANVISA records?
Senior Regulatory Question:
Can the holder access the information and decisions needed to meet ANVISA obligations throughout the complete product lifecycle?
4. BGMP / CBPF Compliance & ANVISA Inspection Readiness
Brazilian Good Manufacturing Practice expectations for medical devices and IVDs are consolidated in RDC 665/2022. For manufacturers of Class III and IV devices, ANVISA CBPF certification is governed by RDC 687/2022 and related administrative requirements. The regulatory issue is not simply whether the manufacturer holds ISO 13485 certification; ANVISA expects evidence that the applicable Brazilian GMP requirements are effectively implemented.
Our Support Includes
- • RDC 665/2022 gap assessment
- • ISO 13485-to-Brazil GMP mapping
- • Design control and design history review
- • Risk-management integration & supplier controls
- • CAPA, complaint and nonconformity systems
- • Process validation and special-process controls
- • Mock inspection and evidence-room preparation
- • MDSAP certificate/audit scope leverage for ANVISA
What We Challenge Before Submission
- • Can the company demonstrate implementation through records, not only SOPs?
- • Are design changes linked to risk management and verification/validation?
- • Are supplier controls commensurate with component/process risk?
- • Are complaints feeding CAPA and risk evaluation?
- • Can manufacturing sites explain outsourced processes and critical suppliers consistently?
MDSAP Consideration:
Where MDSAP evidence is relevant to ANVISA certification strategy, we assess how the available audit/certificate scope can be leveraged and whether any Brazil-specific gaps remain.
Frequently Asked Questions (ANVISA & Brazil)
Key questions manufacturers ask when registering medical devices, IVDs and SaMD in Brazil.
Which medical devices require ANVISA notification or registration?
Under RDC 751/2022, Class I and II medical devices generally follow notification, while Class III and IV devices require registration. IVDs follow RDC 830/2023 and also use risk-based notification/registration pathways.
Does a foreign manufacturer need a Brazilian company?
A foreign manufacturer needs a legally established Brazilian entity with the appropriate regulatory authorization (AFE) to hold the ANVISA notification or registration and act as the local regulatory interface (Brazil Registration Holder).
Is ISO 13485 enough for BGMP?
No. ISO 13485 is highly relevant, but Brazilian GMP requirements are set out in RDC 665/2022. For Class III and IV manufacturing sites, CBPF certification requirements under RDC 687/2022 must also be assessed.
Do Class I and II devices still need a technical dossier?
Yes. The notification pathway does not eliminate technical-documentation obligations. The supporting technical information must be maintained and available to the health authority, and ANVISA can perform subsequent compliance audits.
Can existing EU or FDA testing be used for Brazil?
Often yes, if the evidence applies to the same device, intended use, configuration and claims and satisfies Brazilian requirements. We assess the evidence gap before recommending new testing.
What is different for IVDs in Brazil?
IVDs are regulated under RDC 830/2023. The submission must connect the intended use and risk class with analytical and clinical performance evidence, labeling and post-market requirements.
Does Brazil regulate SaMD separately?
Yes. RDC 657/2022 addresses regularization of Software as a Medical Device. Regulatory status, classification, software evidence, cybersecurity and lifecycle changes must be evaluated.
What is SIUD?
SIUD is ANVISA's Unique Device Identification database. It became operational in 2026 under IN 426/2026, and manufacturers/holders should establish controls so UDI data remain consistent with the regulated product.
How should ANVISA technical questions (exigências) be handled?
The best response identifies the regulatory concern behind the question, determines the evidence gap and answers with a structured technical justification supported by revised documentation or new evidence only where necessary.
Does NKB coordinate testing laboratories?
Yes. We can help define the regulatory testing strategy, coordinate with established laboratories, review protocols and assess final reports for suitability in the Brazilian dossier.
Your Regulatory Partner for Brazil Market Access
Whether you are classifying a new device, appointing a Brazilian registration holder, preparing an ANVISA notification or registration, closing BGMP gaps, coordinating testing, responding to an ANVISA question or managing post-market changes, NKB Regovanta supports the complete Brazilian regulatory lifecycle.