Technical Documentation & Safety/Performance Evidence

ANVISA expects the technical dossier to demonstrate that the device is safe, performs as intended and meets the applicable Brazilian essential safety and performance requirements. RDC 848/2024 updated the essential safety and performance framework and extends it to IVDs. A dossier built for the EU, US or Canada can often be leveraged, but it must be mapped to the Brazilian product, classification and regulatory route.

Review Your Brazil Technical Dossier

When This Support Is Needed

A Class III or IV registration dossier is being prepared for ANVISA submission

A Class I or II notification technical file needs to be verified and made defensible for post-market audit

ANVISA has issued an official exigência requesting technical performance or safety evidence

Existing global technical documentation (EU MDR/IVDR STED or FDA 510(k)) must be adapted to Brazil

What We Challenge Before Submission

Is the tested configuration the exact same as the finished commercial device submitted to ANVISA?

Do pre-clinical laboratory reports support the exact clinical claims made in the Portuguese IFU?

Are test standards and version dates current and acceptable to ANVISA technical assessors?

Are worst-case sample selection and testing rationales scientifically defensible?

Do risk mitigation controls in the risk management file have corresponding verification evidence?

Technical Dossier Components We Review

Device description, principles of operation, and intended use specification

Design, material specifications, and manufacturing process flow information

Essential Safety and Performance Requirements (RDC 848/2024) evidence mapping

Risk-management documentation and benefit-risk evaluation (ISO 14971)

Bench, functional, and mechanical performance test report integration

Biological evaluation and biocompatibility testing evidence (ISO 10993)

Sterilization validation and microbiological barrier documentation

Packaging integrity, transportation transit, and real-time/accelerated shelf-life evidence

Electrical safety and EMC testing evidence (IEC 60601 series & INMETRO where applicable)

Software lifecycle documentation and cybersecurity evidence (IEC 62304 / RDC 657/2022)

Usability and human factors engineering documentation (IEC 62366-1)

Clinical evaluation report (CER) and clinical evidence review

IVD analytical and clinical performance evaluation mapping

Portuguese labeling, IFU, and promotional claims consistency review

Traceability Principle:

We review traceability across Intended Use → Risk → Safety/Performance Requirement → Verification/Validation → Clinical/Performance Evidence → Labeling. The dossier must tell one consistent regulatory story.

Harmonize Your Technical Dossier for ANVISA Acceptance

Our regulatory writers map overseas dossiers to RDC 848/2024 Essential Principles, review pre-clinical data, and compile submission files.

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