Brazil · Medical Device Registration · ANVISA Registro (RDC 751/2022)
Brazil ANVISA Registro Submission for Higher-Risk Devices
We assemble a BRH-ready Registro submission—forms + Technical Dossier—align Portuguese label/IFU, coordinate BGMP where required, and track your case through ANVISA’s decision.
For higher-risk devices that require Registration (Registro) under RDC 751/2022, we assemble a complete submission pack ready for your Brazilian Registration Holder (BRH) to file with ANVISA. That includes forms, Technical Dossier structure, Portuguese labels and Instructions for Use (IFU) alignment, and coordination of Brazil GMP (BGMP) requirements, including the use of MDSAP where applicable.
BRH-ready Registro submission pack
RDC 751/2022 Technical Dossier structure
BGMP / MDSAP coordination
When a Registro Submission Is the Right Route
Situations where a full Registro submission to ANVISA is required and where a structured pack saves time and internal effort:
- Your device falls into a risk class that requires Registration (Registro) and a Technical Dossier under RDC 751/2022.
- You are entering Brazil for the first time and need a BRH-ready submission that matches ANVISA expectations.
- You already sell in other markets and want to reuse evidence and standards in an organized Brazilian dossier.
- Portuguese labels and IFU content must be aligned with the intended claims and approved scope for Brazil.
- BGMP (Brazilian Good Manufacturing Practices) requirements must be planned and linked to your MDSAP status, if applicable.
What You Will Receive
The focus is a complete, BRH-ready Registro submission pack and the coordination needed around BGMP and the BRH interface.
Assembled Registro Submission Pack (BRH-Ready)
- Application forms and core registration data prepared in line with RDC 751/2022.
- Clear separation of what the BRH will submit vs. what is internal technical backup.
- Technical Dossier content inventory and structure, including:
- Device description and intended purpose/claims.
- Models and variants, including grouping logic where applicable.
- Performance and safety evidence list (reports, summaries, key references).
- Standards applied and how they support safety and performance.
- Label and IFU samples in Portuguese for the Brazilian market.
BGMP Coordination (Where Required)
- Plan and tracking logic for Brazil GMP (BGMP) certification where demanded by ANVISA for the chosen route.
- Identification and use of existing MDSAP evidence where applicable.
- Clarification that, when BGMP is issued on the basis of MDSAP, the BGMP certificate may be valid for up to four years instead of two—assuming the manufacturer remains under MDSAP.
- Simple checklist of steps and responsibilities for BGMP-related interactions.
BRH Interface, Submission & Tracking
- Roles and responsibilities between manufacturer, Sobel, and Brazilian Registration Holder (BRH).
- Document list and practical notes for ANVISA’s submission portals and services.
- Support to hand over the assembled pack to the BRH and prepare them to file.
- Monitoring and tracking of the case through ANVISA’s decision, with regular status updates to your team.
How We Assemble Your Registro Submission
A focused process that starts from your existing evidence and ends with a BRH-ready Brazilian pack.
Discovery & scoping
Technical Dossier inventory
Drafting the Registro pack
BGMP / MDSAP coordination
BRH handover & tracking
Scope & Exclusions
We keep the service precisely defined so responsibilities with the BRH and other partners remain clear.
In Scope
- Consulting and documentation support for Registro submissions under RDC 751/2022.
- Assembly of BRH-ready forms and Technical Dossier content.
- Alignment and review of Portuguese labels and IFU texts from a regulatory perspective.
- Planning and coordination around BGMP/MDSAP requirements where applicable.
- Interface coordination with the BRH for a complete and coherent submission.
Out of Scope
- Acting as a government authority or making regulatory decisions on behalf of ANVISA.
- Acting as your Brazilian Registration Holder (BRH), unless contracted separately via a dedicated BRH service.
- Laboratory testing or generation of new technical evidence.
- Label artwork design, printing, and full marketing translations beyond regulatory text alignment.
Inputs We Need From Your Team
- Intended purpose/claims and a clear device description.
- Models/variants and any grouping logic to be used in the Brazil submission.
- Available evidence and applied standards (performance, safety, clinical, risk management) for the Technical Dossier inventory.
- Portuguese labels and IFU—or source text to be aligned into Portuguese.
- Factory BGMP or MDSAP status and any existing plans related to Brazilian GMP.
- Contact details and basic information for the chosen Brazilian Registration Holder (BRH).
FREQUENTLY ASKED QUESTIONS
The Brazilian Registration Holder (BRH) is the formal applicant in Brazil. We assemble the Registro content, structure the Technical Dossier, and coordinate the interface so the BRH can file a coherent package.
Devices that RDC 751/2022 categorizes as requiring Registration and a Technical Dossier—typically higher-risk devices—follow the Registro route. Lower-risk devices may follow the notification route instead.
BGMP is ANVISA’s Brazilian Good Manufacturing Practices certification for manufacturing sites. ANVISA recognizes MDSAP (Medical Device Single Audit Program). When BGMP is granted based on MDSAP, the BGMP certificate validity may be extended to four years, as long as the manufacturer remains under MDSAP.
Labels and IFU for Brazil must be available in Portuguese. We help ensure that the Portuguese content aligns with the intended purpose/claims and the Registro scope.
We do not guarantee processing times; those depend on ANVISA’s workload and internal processes. Our role is to prepare a complete, coherent Registro pack and coordinate tracking through the decision.
Prepare a BRH-Ready Registro Submission for Higher-Risk Devices in Brazil
If your device requires Registro under RDC 751/2022, a loosely assembled set of documents will not be enough. We organize forms and Technical Dossier content into a BRH-ready pack, align Portuguese labels and IFU, and coordinate BGMP/MDSAP aspects—so your Brazilian Registration Holder can submit a clear, defensible case to ANVISA.
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