Brazil · Medical Device Authorization · ANVISA Market Access
A Clear ANVISA Authorization Pathway for Medical Devices Entering Brazil
A structured, Brazil-ready authorization pathway built on your existing regulatory evidence.
Entering Brazil with medical devices means dealing with ANVISA, local representatives, and market-specific regulatory expectations.
We help international manufacturers structure a clear authorization pathway, organize existing evidence into a Brazil-ready package, align key documents in Portuguese, and coordinate with local partners — reducing rework and regulatory back-and-forth.
What this service helps you achieve
A clear ANVISA authorization route aligned with your device portfolio
Structured reuse of EU and US approvals and technical evidence, adapted to Brazil
Clearly defined roles between manufacturer, Sobel, and Brazilian partners
Portuguese labels and IFUs aligned with intended use and regulatory scope
Core areas of support
Brazil market access & ANVISA authorization support
Structured, Brazil-ready documentation and strategy
Coordination with local partners and stakeholders
When ANVISA Authorization Support Is the Right Route
Dedicated regulatory and market access support for Brazil is especially valuable when your team needs clarity, predictability, and alignment across regions and partners.
- You plan to enter Brazil with medical devices and need clarity on which authorization route and regulatory expectations apply.
- You already sell in other regions and want to reuse existing evidence and approvals in a structured, Brazil-compliant way.
- You need Portuguese labels and Instructions for Use (IFU) aligned with intended purpose, claims, and regulatory scope for Brazil.
- Your internal team has limited experience with ANVISA and wants a structured, predictable process.
- You work with—or are selecting—a local partner in Brazil and want roles, responsibilities, and documentation clearly defined.
What You Will Receive
You receive a Brazil-specific market access strategy combined with a practical, ANVISA-oriented documentation and coordination package that your internal teams and local partners can actively use.
Brazil Market Access & Regulatory Strategy
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- High-level assessment of your products, intended use, and commercial goals for Brazil.
- Clear identification of applicable regulatory pathways and authorization routes.
- Structured analysis of how existing approvals and evidence (e.g. EU/US) can be leveraged for Brazil, including reuse, adaptation, and potential gaps.
- Initial timeline and risk overview to support internal planning.
- Clear definition of roles between your organization, Sobel, and local partners.
Built on Your Existing Regulatory Evidence
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- Inventory and organization of available technical and regulatory documentation relevant to Brazil.
- Guidance on how to structure documentation in a way that reflects ANVISA expectations.
- Alignment of key label and IFU content into Portuguese, focused on intended purpose, claims, and regulatory scope.
- Practical guidance on how your global documentation should be adapted (rather than rebuilt) for Brazil.
- Clear distinction between what will be used directly in submissions and what remains as internal supporting evidence.
Local Coordination & ANVISA Interface Support
Preparation and support for UDI/Devices entries using your existing Basic UDI-DI, UDI-DI, UDI-PI, and Annex VI data. We structure your information for the module, highlight obvious inconsistencies, and guide you through entering and saving records in EUDAMED.
- Definition of roles and responsibilities between manufacturer, Sobel, and local Brazilian partners.
- Practical notes on systems, portals, and services typically used in Brazil for regulatory interactions.
- Support to prepare local partners to work with the assembled documentation package.
- Tracking logic and communication routines for follow-up, questions, and status updates related to ANVISA processes.
Scope: Data preparation and registration support only. We do not design your UDI structure, do not create or interpret Annex VI data for you, do not select issuing agencies, and do not act as a notified body, importer, or label designer. All core Annex VI content and identifiers come from your organisation.
Device records registered in EUDAMED using your own identifiers and data.
Label & IFU Confirmation
- Check that BRH identification appears correctly on labels and IFUs, as required.
- Support for electronic IFU portal upload where applicable.
- Basic alignment of regulatory text in labels/IFUs with the granted registrations/notifications.
Change & Revalidation Plan
- Categorize post-approval changes (approval-required, immediate implementation, non-reportable) under RDC 751/2022.
- Maintain a calendar and tracking logic for 10-year registration validity and revalidation.
- Outline a simple governance model so technical and commercial teams know when to involve the BRH.
Vigilance & Field Actions Routing
- Define who reports what, to whom, and when for Brazil-specific vigilance signals and field actions.
- Clarify timelines and roles for ANVISA notifications, customer communications, and follow-up reporting.
- Ensure vigilance documentation supports registration and labeling obligations.
How We Support Your ANVISA Authorization
A stepwise approach that starts from your existing regulatory evidence and results in a Brazil-ready documentation package with clearly defined coordination across all stakeholders.
Discovery & Scoping
Regulatory Roadmap for Brazil
Structuring the Brazil-Ready Pack
Local Partner & Stakeholder Coordination
Handover & Ongoing Support
Label/IFU confirmation
Maintenance & vigilance
Scope & Exclusions
We keep the service precisely defined so your internal team, Sobel, and your partners in Brazil understand who does what—and where additional services might be needed.
In Scope
- Consulting and documentation support for medical device market access and authorization in Brazil.
- Development of a Brazil-specific regulatory and market access strategy.
- Organization and structuring of a Brazil-ready documentation package based on your existing evidence.
- Alignment and regulatory review of core Portuguese label and IFU content.
- Coordination of roles and responsibilities with local Brazilian partners involved in regulatory processes.
Out of Scope
- Acting as a government authority or making regulatory decisions on behalf of ANVISA.
- Acting as your Brazilian Registration Holder (BRH) or equivalent local legal entity, unless contracted separately via a dedicated service.
- Laboratory testing or generation of new technical or clinical evidence.
- Full marketing translations, graphic label design, printing, and commercial artwork creation beyond regulatory text alignment.
Inputs We Need From Your Team
- Clear description of your devices, intended purpose, and key claims.
- Overview of models/variants and how you plan to position them in the Brazilian market.
- Available technical and regulatory documentation, including evidence and applied standards.
- Existing label and IFU content (or source text) to be aligned to Portuguese and to Brazilian expectations.
- Information on your current or planned local partners and legal representatives in Brazil.
- Internal timelines, priorities, and constraints for Brazil market entry.
Consulting and documentation support only. We do not design UDI schemes, do not create Annex VI data, do not select issuing agencies, and do not act as a notified body, importer, or label designer. You remain responsible for UDI assignment, Annex VI content, technical documentation, and all formal submissions in EUDAMED.
When You Need a Brazilian Registration Holder
Typical situations where appointing a BRH becomes essential for Brazil market access:
- You are a foreign medical device manufacturer without a Brazilian legal entity but want to place devices on the Brazilian market.
- You need a single, stable license holder that is not tied to any one distributor, so you can keep commercial options open.
- You want to file notifications/registrations under RDC 751/2022 and maintain them over time, including changes and revalidation.
- You need someone to be clearly identified on Brazilian labeling/IFU as the holder responsible before ANVISA.
- You want vigilance and field actions in Brazil to follow defined timelines and routing, without ad-hoc email chains.
FREQUENTLY ASKED QUESTIONS
In Brazil, a locally established legal entity typically acts as the formal counterpart to ANVISA. We support by preparing and structuring the documentation and by coordinating the interface so your local partner can work with a clear, coherent package.
Medical devices placed on the Brazilian market generally need to follow ANVISA’s regulatory framework, with different routes and expectations depending on the device type and risk profile. We help you understand which path applies to your portfolio.
In many cases, yes. Approvals and evidence from other regions (e.g. EU, US) are valuable starting points. We focus on reusing and adapting what you have, while addressing the specific needs of the Brazilian system.
For Brazil, labels and IFU must be available in Portuguese. We help align the Portuguese content with your intended purpose/claims and ensure consistency with the authorized scope in Brazil.
No consultancy can guarantee processing times, as they depend on ANVISA’s workload and internal processes. Our role is to prepare a complete, well-structured package and to support coordination and tracking to reduce avoidable delays.
Plan Your Path to the Brazilian Market
If Brazil is part of your market expansion plans — or if ANVISA requirements currently feel fragmented — a structured, Brazil-focused regulatory perspective can reduce uncertainty and accelerate decision-making.
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