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Clinical evidence · Brazil

Clinical evaluation for ANVISA, built on the evidence you have

ANVISA expects the indications, performance and safety of a medical device to be supported by clinical evidence. We prepare and update the clinical evaluation for your Brazilian file, building on what you already have for the EU or the US.

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Is this for you?

Who we do this for

Class III or IV registrationYour ANVISA dossier needs a summary of the clinical evidence.

CE or FDA file in handYou have a clinical evaluation report or clinical data to adapt.

ANVISA requirementANVISA asked questions about the clinical evidence in your submission.

New device or new indicationYou may need new clinical data. We help you decide whether a study is needed and what it involves.

What you get

What you receive

A clinical evaluation structured for the ANVISA dossier.

Clinical evaluation plan, with scope and literature search protocol
Clinical evaluation report: literature, your own data and post-market experience
Analysis of comparable devices, when you rely on their data
Gap analysis of your EU or FDA clinical file for the Brazilian dossier
Clinical evidence summary for the registration dossier
Answers to ANVISA requirements and updates after changes

What ANVISA looks at

The main points behind the clinical part of your Brazilian file. How they apply depends on the device.

Clinical evidence for the claimsIndications, performance and safety should be supported by relevant clinical data.

Literature and your own dataThe evaluation usually combines a critical review of the literature with your own clinical and post-market data, favourable and unfavourable, and is kept up to date.

When a study may be neededWhen existing data are not enough, for example for innovative devices or new indications, a clinical investigation may be needed.

Studies in BrazilClinical investigations in Brazil follow ANVISA and ethics procedures. We help you understand what applies to your device.

How it works

1ReviewWe look at the device, its claims, its class and the clinical data you already have.
2PlanWe define the scope, the use of comparable devices and the literature search protocol.
3ReportWe write the evaluation following RDC 848/2024 and the ANVISA guidance on clinical evaluation.
4Filing and updatesWe support the submission, answer requirements and update the report after changes.

Talk to a specialist

Keep exploring

Medical Devices · BrazilClasses, routes and the full ANVISA pathway.→Brazilian Registration HolderA holder through our qualified partner, independent from your distributors.→Product stuck at ANVISA?Rejected or stalled filings, analysed and answered.→

Why Sobel

Regulation as a business decision, not a checklist.

Four disciplines work on every project, in the same team, from the first decision to post-market.

Strategy

Classification and market sequence decided first. The right class from day one avoids rework.

Science in house

Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.

Regulatory, five markets

ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.

Technology

A dedicated technology team builds the workflows that keep every project traceable and on time.

“We know how auditors think, because we’ve been one of them.”

Maik Endler

Founder & CEO

Mechanical engineer, trained in Germany
Former BSI auditor (Notified Body)
Industry experience at Sirona (now Dentsply Sirona)

Questions, answered

Frequently asked questions

Rules cited on this page: RDC 848/2024 · RDC 751/2022 · RDC 837/2023 · IN 290/2024 · ANVISA Guide 31/2020 · ISO 14155

Can we use our EU clinical evaluation report?

Yes, as a starting point. Your EU or FDA data can support the Brazilian evaluation, adapted to what ANVISA expects. We map your report to the Brazilian dossier and add what is missing, such as the indications and labelling declared in Brazil. For some higher-risk devices already authorised in certain markets, ANVISA rules allow the foreign authority’s assessment to be considered; we check whether your device can use this.

Do Class I and II devices need a clinical evaluation?

The clinical evaluation rules apply to all classes, but what is submitted differs. For notified devices, the documentation usually stays with the holder and is presented if ANVISA asks for it. For registered devices, a clinical evidence summary is part of the dossier.

When is a clinical investigation in Brazil needed?

When existing data are not enough to support the claims. Studies run in Brazil follow ANVISA and ethics committee procedures, which vary with the device and the study. We assess your case and help you plan the route.

Does ANVISA publish guidance on clinical evaluation?

Yes. ANVISA guidance describes the literature search, the use of comparable devices and the structure of the report. We apply it together with the current rules.

Who prepares the evaluation?

Our Clinical Evidence & Product Safety specialists, together with the regulatory team that prepares the rest of your ANVISA dossier.