Medical devices · IVD · Cosmetics
Your regulatory path to Brazil.
Medical devices, IVD and cosmetics are regulated by ANVISA. We plan your route from Brazil and, through a qualified partner, provide your local registration holder.
Medical devices · IVD · Cosmetics · ISO 9001 certified in Brazil · Service in PT · EN · DE
WHERE YOU ARE COMING FROM
Two starting points, one market
Manufacturer outside Brazil
You want to sell in Brazil and need a company in Brazil to hold your registration.
- A Brazilian registration holder, through a qualified, approved partner
- Your technical file adapted to ANVISA, in Portuguese
- Reuse of what you already have from CE or FDA, where possible
Brazilian manufacturer
You produce in Brazil and need to register, keep your products compliant or grow abroad.
- Registration or notification with ANVISA
- Quality system and audits
- Next markets: Europe, the UK, the USA and Canada
What are you bringing to Brazil?
Each product follows its own ANVISA rules. Pick yours for the full path.
Medical Devices
Implants, equipment and software, from classification to registration.
In Vitro Diagnostics
Reagents, analysers and tests, from classification to registration.
SERVICES IN BRAZIL
Everything we do in Brazil
From our team in Valinhos, São Paulo, with your files in Portuguese.
Strategy and classification
Class, route and timeline before any file is built.
ANVISA notification and registration
Dossier, submission and answers to requirements.
Quality system, B-GMP and MDSAP
RDC 665/2022, mock inspections and audits.
INMETRO and Anatel
Certification for electromedical and wireless devices.
Biological and clinical evaluation
ISO 10993 and clinical evidence for ANVISA.
Cosmetic safety assessment
Safety documentation for your formulas.
Brazilian Registration Holder
Through a qualified, approved partner.
Ongoing support
Monthly support for changes and renewals.
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)
FAQ · BRAZIL
What companies ask before entering Brazil
Short answers for medical devices, IVD and cosmetics. Each product page goes into the details.
Ask your question →Who regulates medical devices, IVD and cosmetics in Brazil?
All three are regulated by ANVISA, Brazil’s health regulatory agency. The core rules are RDC 751/2022 for medical devices, RDC 830/2023 for in vitro diagnostics and RDC 752/2022 for cosmetics.
Do I need a company in Brazil to sell my product?
Yes. The notification or registration must be held by a company established in Brazil. A Brazilian Registration Holder can hold it on your behalf, so you stay free to choose your distributors. Sobel offers this service through a qualified partner. Learn about the Registration Holder service.
Can I reuse my CE marking or FDA file for ANVISA?
ANVISA does not accept a foreign approval on its own, but much of your technical file, test reports and evidence can often be reused and adapted. What can be reused depends on a technical assessment of your file.
Do labels and instructions need to be in Portuguese?
Yes. Labels and instructions for use must be in Brazilian Portuguese and follow ANVISA’s labelling rules for each product type.
