Europe
EUDAMED Deadline 2026: What to Do Before 27 November
Your devices have been on the EU market for years. They have valid certificates, a
September 28, 2026
IN VITRO DIAGNOSTICS · BRAZIL
From classification under RDC 830/2023 to life on the market, Sobel turns ANVISA requirements into a clear plan for reagents, analyzers, rapid tests and self-tests.
🏆 Top Medical Device Regulatory Consultant · LatAm 2025
✓ ISO 9001 certified
🌐 Service in PT · EN · DE
WHY BRAZIL
+8.4%
Reagents and analyzers led growth among medical devices in Brazil.
US$ 1.8 bn
Projected to grow about 8% a year until 2030.
MDSAP
With an MDSAP report, ANVISA certifies without inspection, valid for 4 years.
Sources: ABIIS, Brazilian Alliance of the Innovative Health Industry (2025); MarketsandMarkets (market estimate); ANVISA, RDC 850/2024.
BRAZIL ESSENTIALS
In Brazil, the class follows the intended use in your IFU, not only the analyte. Classes I and II follow notification; Classes III and IV require registration and B-GMP.
Hover over or tap a product to see what each class requires.
Low risk
Notification · simpler path
Examples: Specimen receptacles, culture media and general laboratory instruments.
What it takes in Brazil
Medium risk
Notification · simpler path
Examples: Clinical chemistry for professional use, such as glucose or cholesterol.
What it takes in Brazil
High risk
Registration · more complex review
Examples: Self-tests, sexually transmitted infections and cancer markers.
What it takes in Brazil
Highest risk
Registration · more complex review
Examples: Blood screening for HIV and hepatitis, and ABO blood grouping.
What it takes in Brazil
Examples are illustrative: the final class depends on the intended use under RDC 830/2023.
WHAT MAKES BRAZIL DIFFERENT
What your IVDR or FDA experience will not tell you about ANVISA.
The same analyte can be Class II or III depending on the claims in your IFU.
RDC 830/2023 moved many products from Class II to III, from notification to registration.
Sensitivity, specificity and reference values are expected for higher-risk IVDs.
Class III and IV need ANVISA B-GMP. With MDSAP it is granted by document review, valid for 4 years.
Related IVDs can be grouped into families, and Class III and IV products approved abroad may use a reliance route.
Portuguese labeling without distributor data, IFU in ANVISA’s repository and UDI data in SIUD.
IVD SERVICES IN BRAZIL
STRATEGY
Confirm class and route before you invest.
Ideal for: first-time entry into Brazil
QUALITY
Manufacturing certification for Class III and IV.
Ideal for: Class III and IV IVDs
EVIDENCE
Your IVDR or FDA file, adapted for ANVISA.
Ideal for: manufacturers with CE or FDA
SUBMISSION
Submission, requirements and publication.
Ideal for: every IVD entering Brazil
REPRESENTATION
A holder independent from your distributor.
Ideal for: foreign manufacturers
LIFECYCLE
Life after approval, handled continuously.
Ideal for: products already on the market
Working with medical devices? See Medical Devices · Brazil →
RECOMMENDED FOR FOREIGN MANUFACTURERS
Everything you need to place your IVD on the Brazilian market, coordinated by one team and one contact.
Class under RDC 830/2023 and the notification or registration path.
Technical dossier, performance data and Portuguese labeling and IFU.
Filing, requirements and publication.
Local representation and vigilance.
Optional: B-GMP certification · MDSAP route · registration transfer from a distributor
HOW WE WORK WITH YOU
Pick the model that fits where your IVD is today, and switch when it changes.
Project
You have a device to launch or a problem to solve now.
Best when you
What you get
Partnership
Your devices are on the market, and the rules keep moving.
Best when you
What you get
FOR CONSULTANCIES AND PARTNERS
Regulatory consultancies, authorized representatives and CROs abroad work with Sobel when their clients need Brazil. We execute locally, you keep the lead.
WHY SOBEL
Certified quality management in every project.
Brazilian and European experience in one team.
Professionals with IVD registration experience in this market.
Your registrations stay under your control, not your distributor’s.
CLIENT VOICES
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“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas Kohl
CEO · Andratec
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“I experienced always supportive, pro-active collaboration from Sobel Consult with high degree of competency in broad regulatory range.”
Mandy Blocher
Expert Regulatory Framework & Digital Transformation · Aesculap AG (B. Braun)
Clear regulatory direction
The right pathway and priorities for your product.
Fast and responsive support
We act quickly to keep projects moving.
Practical guidance
Actionable advice for your next step.
Discover trends, tips, and expert insights to keep you ahead.
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