Brazil · ANVISA Notificação · RDC 751/2022
Brazil ANVISA Notificação for Class I/II Devices
We assemble a complete Notificação filing package for Class I/II medical devices — BRH-ready for ANVISA submission, with Portuguese label/IFU checks and tracking to publication of your notification number.
For low-risk devices going through the Notificação pathway, we build a complete ANVISA-ready filing package for your Brazilian Registration Holder (BRH). We confirm classification, organize the dossier content, verify Portuguese labels and Instructions for Use (IFU), and track the process through to publication of your notification number.
Class I/II Notificação pathway
BRH-ready package
Portuguese label/IFU check
When a Structured Notificação Package Is Essential
Typical situations where a standardized Notificação filing saves time and avoids rework:
- You are a foreign manufacturer bringing Class I/II devices into Brazil for the first time.
- Your team is unsure how RDC 751/2022 defines risk classes and when Notificação vs. Registro applies.
- You want to avoid back-and-forth on petition “assunto”, forms, and required declarations.
- You need a clear interface with a BRH, so they receive exactly what they need to file.
- You want a predictable path to publication of the notification number before starting marketing.
What You Will Receive
The service is focused on one outcome: a complete, BRH-ready Notificação filing package plus label/IFU checks and tracking.
Assembled Notificação Filing Package (BRH-Ready)
- Confirmation of risk class and suitability of the Notificação pathway under RDC 751/2022.
- Clear mapping of content to the correct petition “assunto” in ANVISA’s system.
- Full dossier content for Class I/II notification, including:
- Device description and intended use/claims.
- Models and variants, with grouping notes (family, system, kit) where applicable.
- Required ANVISA forms and declarations compiled and formatted for portal submission.
Portuguese Label/IFU Compliance Check
- Verification that mandatory label elements are present in Portuguese.
- Check that IFU is available in Portuguese and consistent with intended use and claims.
- Documentation of how users access the IFU when it is not enclosed (where allowed for some Class I/II cases).
BRH Submission Coordination & Tracking
- Defined roles between manufacturer, Sobel, and BRH.
- Filing checklist for the BRH, including required files and sequence.
- Tracker from initial filing to publication of the notification number, with clear status points.
How We Assemble Your Notificação Package
A straightforward process that starts from your existing documentation and ends with a ready-to-file ANVISA package.
Classification & scoping
Dossier compilation
Forms & declarations
Label/IFU PT check
BRH handover & tracking
Scope of the Service
We define clearly what is included and what remains outside this service.
Included
- Confirmation of classification and suitability for Notificação (Class I/II).
- Dossier compilation for the Notificação pathway under RDC 751/2022.
- Portuguese label and IFU compliance check from a regulatory perspective.
- BRH interface and tracking from filing to notification publication.
Excluded
- Acting as ANVISA or making decisions on behalf of the authority.
- Acting as your BRH (this requires a separate BRH service contract).
- Laboratory testing or generation of new technical evidence.
- Factory licensing and GMP audits.
Inputs We Need From Your Team
- Intended use and device description.
- Models and variants, with family/system/kit grouping logic if applicable.
- Applied standards and a list of supporting evidence available.
- Draft Portuguese labels and IFU, or source text to be aligned into Portuguese.
- Contact details for your Brazilian Registration Holder (BRH), or a request to use Sobel’s separate BRH service.
FREQUENTLY ASKED QUESTIONS
A Brazilian legal entity—the Brazilian Registration Holder (BRH)—files and holds the notification. Foreign manufacturers operate through that entity. We prepare the package and coordinate the interface.
Generally Class I and Class II devices follow the Notificação route under RDC 751/2022, provided they meet the criteria set by the regulation.
ANVISA’s service page indicates an estimated timeframe of up to 30 calendar days when the petition is correct and complete. Errors or missing data can pause or reset this timeline.
Labels and IFU must be available in Portuguese for the Brazilian market. We check this from a regulatory perspective as part of the Notificação package.
Yes, we can act as your BRH but it must be contracted separately.
Assemble a Predictable, BRH-Ready Notificação for Brazil
If you want a fast, predictable route to regularize Class I/II devices in Brazil, a structured Notificação package is essential. We confirm the pathway, compile the dossier, verify Portuguese label/IFU content, and keep your BRH on track through filing and publication of the notification number.
Contact Us
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