Brazil Medical Device Registration · RDC 751/2022 · ANVISA
Appoint Sobel as Your Brazilian Registration Holder (BRH)
Appoint Sobel as your Brazilian Registration Holder (BRH). We hold the license before ANVISA and keep your Brazil filings and obligations on track.
Appoint Sobel as your Brazilian Registration Holder (BRH)—the legal license holder before ANVISA—for medical devices under RDC 751/2022. We help you file, obtain, and maintain notifications and registrations, keep change categories under control, manage 10-year revalidation, and route vigilance and field actions on time.
Independent BRH for Brazil
RDC 751/2022 compliant filings
Changes, revalidation & vigilance organized
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.
Why the Brazilian Registration Holder Role Matters
The Brazilian Registration Holder (BRH) is the legal license holder for your device before ANVISA. Without a BRH, foreign manufacturers cannot file or maintain notifications or registrations in Brazil.
In short: without a reliable BRH, Brazil market access and post-market duties cannot be properly executed or defended.
What You Will Receive
Our BRH service is focused on being your legal license holder in Brazil and keeping all regulatory obligations organized under RDC 751/2022.
BRH Appointment Pack
- Appointment letter and powers of attorney needed to formalize Sobel as your Brazilian Registration Holder.
- Clear contact points for operational, regulatory, and vigilance topics.
- Escalation paths for urgent ANVISA interactions or field actions.
ANVISA Filing Readiness
- Applicant and product forms prepared in line with RDC 751/2022 requirements.
- Intake and review of technical dossier elements (device description, risk class, safety and performance evidence).
- Confirmation when a Brazilian GMP certificate is required for specific registration paths, based on device class and route.
Notification & Registration Submission
- Submission of Class I–II notifications and Class III–IV registrations to ANVISA.
- Coordination of fee payments, response to basic ANVISA process queries, and tracking of status.
- Capture and organization of grant/publication evidence for internal and external stakeholders.
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 Work as Your BRH (6 Steps)
A clear operational model so you know how Sobel acts as your Brazilian Registration Holder from first contact through long-term maintenance.
Discovery & scope
Appointment & setup
File preparation
Submission & tracking
Label/IFU confirmation
Maintenance & vigilance
Scope & Boundaries
To keep roles clear, we distinguish precisely what is in scope for the BRH service and what is not.
In Scope
- BRH representation before ANVISA for medical devices.
- Notifications and registrations under RDC 751/2022, including changes and revalidation planning.
- Labeling and IFU identification checks to ensure BRH details are correctly presented.
- Planning and categorization of post-approval changes (approval-required, immediate implementation, non-reportable).
- Routing of vigilance and field actions to meet ANVISA notification expectations.
Out of Scope
- Laboratory testing or performance/biocompatibility studies.
- Label artwork design, printing, or packaging production.
- Full marketing translations beyond inserting required regulatory wording.
- Commercial distribution or acting as a sales/distribution entity in Brazil.
Inputs We Need From Your Team
- Manufacturer authorization statement appointing Sobel as BRH.
- Existing dossier materials (technical file, risk management, clinical/performance evidence).
- Country-of-origin authorizations/approvals, where required for certain registration routes.
- Evidence for GMP when needed (e.g., Brazilian GMP or recognized GMP for specific pathways).
- List of Brazilian distributors or partners (if any), so responsibilities and communication lines are clear.
Why Manufacturers Choose Sobel as Their Brazilian Registration Holder
Sobel combines regulatory rigor with operational clarity: we understand ANVISA expectations under RDC 751/2022 and translate them into a manageable BRH model for foreign manufacturers.
- Independent BRH, allowing you to keep distributor options open while centralizing license ownership.
- Critical, pragmatic handling of filings, changes, and revalidation—focused on what ANVISA expects, not on unnecessary complexity.
- Clear routing of vigilance and field actions so you meet Brazilian timelines without ad-hoc decisions.
- Transparent communication with regulatory and operations teams, so obligations and statuses are always visible.
- Experience coordinating Brazil registrations as part of broader global regulatory strategies.
FREQUENTLY ASKED QUESTIONS
Any foreign medical device manufacturer without a Brazilian legal entity needs a BRH to file, hold, and maintain notifications or registrations with ANVISA.
Yes. Under RDC 751/2022, the registration holder must be identified on labeling and typically on the IFU, making it clear who is responsible before ANVISA.
Registrations are generally valid for 10 years, with revalidation in equal periods. A structured calendar and plan help avoid gaps in validity.
The BRH must notify ANVISA within defined timelines when field actions or relevant vigilance events occur. Our service defines who reports what, to whom, and when, so these obligations are not missed.
No. We act as the Brazilian Registration Holder for regulatory purposes. Commercial distribution remains with your chosen partners, which can change without changing the BRH.
Yes. We help categorize post-approval changes under RDC 751/2022, manage the required filings, and maintain a clear record for audits and inspections.
Appoint an Independent Brazilian Registration Holder and Keep Brazil Under Control
If you want to enter or stabilize your presence in Brazil without creating a local legal entity or locking your license to a single distributor, appoint Sobel as your Brazilian Registration Holder. We hold the license before ANVISA, manage filings and maintenance under RDC 751/2022, and keep vigilance and revalidation on track.
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