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RDC 751/2022 & SIUD Database
Portuguese Labeling, IFU, UDI & SIUD Compliance
Brazilian market access requires labeling and instructions for use to remain consistent with the ANVISA regularization, intended purpose, manufacturer/holder information and technical evidence. UDI requirements under RDC 591/2021 are being implemented by risk class, and ANVISA's SIUD database has been operational since March 2026 under IN 426/2026.
When This Support Is Needed
Preparing Brazilian Portuguese labels, packaging artwork, and IFUs for initial market launch
Updating Brazil Registration Holder details or legal manufacturer corporate data
Implementing physical and barcode UDI on medical device labels and packaging levels
Preparing, formatting, or transmitting UDI data records directly to ANVISA's SIUD database
Evaluating whether a proposed labeling update could affect approved clinical indications or claims
What We Challenge Before Submission
Does the Portuguese label accurately identify both the authorized Brazilian holder and the legal manufacturer?
Are Portuguese claims identical in clinical meaning to the approved global intended use and technical file?
Do UDI-DI identifiers and SIUD metadata match the regulated product models and packaging hierarchy?
Does a proposed minor labeling change inadvertently introduce a new clinical indication or risk claim?
Are storage temperature, humidity, sterility, and expiration statements fully supported by study validation?
Our Labeling & UDI Support Scope
Brazilian Portuguese labeling compliance review (RDC 751/2022 & RDC 830/2023)
Instructions for Use (IFU / Manual de Instruções) review and translation-control strategy
Legal manufacturer and Detentor do Registro (BRH) identification on primary/secondary packaging
Model, catalogue code, variant, and trade name consistency review
Standardized symbols, contraindications, warnings, and precautions alignment
Sterility, storage condition, and validated shelf-life statement verification
IVD-specific labeling, analytical performance specifications, and handling instructions
Electronic labeling (e-IFU / Instruções de Uso em formato eletrônico) eligibility and implementation
UDI applicability and phased implementation readiness (RDC 591/2021)
UDI-DI / packaging hierarchy strategy and data governance
SIUD database record compilation, verification, and transmission under IN 426/2026
Change impact assessment for post-approval labeling and IFU revisions
Consistency Rule:
We compare the public-facing product information against the approved/notified regulatory data and technical evidence. Labels, IFUs, UDI data and ANVISA records should identify the same device and support the same intended use.
Harmonize Your Portuguese Packaging and Maintain SIUD Compliance
Our labeling consultants audit artwork for RDC 751/2022 conformity, review translations, and manage SIUD electronic submissions.