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MEDICAL DEVICES · BRAZIL
ANVISA registration for medical devices in Brazil.
From classification to post-market, Sobel turns ANVISA requirements into clear decisions, structured execution and secure market access for your device.
WHY BRAZIL
A market that buys what it doesn’t make
#1
Largest healthcare market in Latin America
Health spending of 9.7% of GDP (IBGE, 2021).
US$ 10.2 bn
Medical devices imported in 2025
Up 10.9% on 2024. Imports exceed exports by US$ 9.2 billion.
MDSAP
A recognized regulatory system
ANVISA is one of the five MDSAP authorities, with the US, Canada, Japan and Australia. In 2024, 61% of the GMP certificates it issued were based on MDSAP audit reports.
Sources: IBGE, Conta-Satélite de Saúde (2021 data) and U.S. International Trade Administration; ABIIS economic bulletin, March 2026 (Comex Stat data); ANVISA, MDSAP use in Brazil (IMDRF, 2026).
IS THIS FOR YOU?
Who we do this for
Brazil is your first market
You need the right class and route before any file is built.
You already have CE or FDA
You want to reuse your technical documentation and add only what Brazil requires.
You need a new holder
Your registration is held by a distributor and you want an independent holder.
Your submission is stuck
A technical requirement, a rejection or months without an answer from ANVISA.
BRAZIL ESSENTIALS
Where does your device fit?
Classes I and II follow notification, Classes III and IV need registration.
Hover over or tap a product to see what each class requires.
Class I
Low risk
Notification · simpler path
Examples: Stethoscopes, reusable surgical instruments, non-sterile bandages.
What it takes in Brazil
- Notification to ANVISA
- Technical documentation kept by the holder
- No BGMP certificate required
In every class: a Brazilian holder, labels and IFU in Portuguese, and INMETRO or Anatel when applicable.
Class II
Medium risk
Notification · simpler path
Examples: Syringes, hearing aids, diagnostic ultrasound.
What it takes in Brazil
- Notification to ANVISA
- Technical documentation kept by the holder
- No BGMP certificate required
In every class: a Brazilian holder, labels and IFU in Portuguese, and INMETRO or Anatel when applicable.
Class III
High risk
Registration · more complex review
Examples: Infusion pumps, orthopedic implants and bone screws.
What it takes in Brazil
- Registration with a full technical dossier
- BGMP certificate, which an MDSAP report can support
- Biological and clinical evidence
In every class: a Brazilian holder, labels and IFU in Portuguese, and INMETRO or Anatel when applicable.
Class IV
Highest risk
Registration · more complex review
Examples: Heart valves, breast implants, coronary stents.
What it takes in Brazil
- Registration with a full technical dossier
- BGMP certificate, which an MDSAP report can support
- Robust clinical evidence, often with clinical data
In every class: a Brazilian holder, labels and IFU in Portuguese, and INMETRO or Anatel when applicable.
Examples are illustrative: the final class depends on the device and its intended use under RDC 751/2022. Working with IVDs? See IVD · Brazil →
THE BRAZIL PATHWAY
The full lifecycle of your device in Brazil
Step 01
Strategy & classification
Before any document is written, we define the risk class under RDC 751/2022, the route (notification or registration) and what each target market will require.
What we deliver
- Risk classification
- Regulatory route per market
- Gap overview and priorities
Step 02
Quality system
Your QMS aligned with ISO 13485 and RDC 665/2022, with BGMP certification support when required and MDSAP readiness for multi-market access.
What we deliver
- Gap analysis (RDC 665 / ISO 13485)
- Internal audits
- BGMP and MDSAP support
Step 03
Safety & clinical evidence
Biological and clinical evaluation built once and reused across markets. We review existing data first and test only where data is missing.
What we deliver
- BEP and BER (ISO 10993-1:2025)
- Toxicological risk assessment (ISO 10993-17)
- CEP and CER
Step 04
Technical file & certifications
The technical dossier organized the way ANVISA reviews it, with IFU and labels in Portuguese and the INMETRO or Anatel certificate when your device needs one.
What we deliver
- Technical dossier and critical review
- IFU and labels in Portuguese
- INMETRO or Anatel certification
Step 05
Submission & approval
Filing, follow-up and answers to ANVISA requirements until publication.
What we deliver
- Notification (Classes I and II)
- Registration (Classes III and IV)
- Answers to requirements (exigências)
Step 06
Local representation
Foreign manufacturers need a Brazilian holder for the registration. Our qualified partner acts as holder, independent from your distributors.
What we deliver
- Brazilian Registration Holder
- Technovigilance and contact with ANVISA
- Freedom to change distributors
Step 07
Post-market
Keep your product compliant after approval: changes, new models, revalidation every 10 years and vigilance, with a regulatory team on demand.
SERVICES IN BRAZIL
ANVISA services for medical devices
STEP 01
Regulatory Strategy & Classification
Know your class and route before you invest.
- Class and route confirmed in writing
- Market sequence with EU, US and Canada
- Timeline and budget before you start
Ideal for: first-time entry into Brazil
STEP 02
QMS, BGMP & MDSAP
A quality system ready for ANVISA inspection.
- QMS built or adapted to RDC 665/2022
- Mock inspection before the ANVISA audit
- MDSAP audit preparation
Ideal for: manufacturers in Brazil and abroad
STEP 03
Biological & Clinical Evaluation
Safety and clinical evidence built once, reused across markets.
- Evidence gap analysis before any test
- Lab testing planned and coordinated
- One file reused for other markets
Ideal for: devices in contact with the body
STEPS 04–05
ANVISA Registration & Notification
Dossier, submission and follow-up until publication.
- Filing in the ANVISA system
- Answers to technical requirements
- Follow-up until publication
Ideal for: every device entering Brazil
STEP 04
INMETRO & Anatel
Certification for electromedical and connected devices.
- INMETRO for electromedical equipment
- Anatel for wireless devices
- Certificate ready before the ANVISA filing
Ideal for: electromedical devices
STEP 06
Brazilian Registration Holder
Your Brazilian holder through our qualified partner, without opening a company.
- Holds the registration on your behalf
- Vigilance and ANVISA contact
- Transfer from a current holder
Ideal for: foreign manufacturers
Working with IVDs? See IVD · Brazil →
RECOMMENDED FOR FOREIGN MANUFACTURERS
ANVISA Entry Package
Everything you need to place your device on the Brazilian market, coordinated by one team and one contact.
Classification & route
Risk class and notification or registration path.
Technical file
Dossier, Portuguese IFU and labels.
Submission & follow-up
Filing, requirements and publication.
Registration holder, year one
Local representation and vigilance.
Optional: INMETRO / Anatel · BGMP certification support · sworn translations
HOW WE WORK WITH YOU
Start with a project. Stay with a partner.
Pick the model that fits where your device is today, and switch when it changes.
Project
Regulatory Projects
You have a device to launch or a problem to solve now.
What you get
- Fixed scope, price and timeline agreed upfront
- A defined deliverable, from dossier to approval
- One contact from kickoff to publication
Partnership
Ongoing Support
Your devices are on the market, and the rules keep moving.
What you get
- A monthly plan with predictable cost
- Regulatory and scientific support in one team
- A team that already knows your products
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)
CLIENT VOICES
Trusted for decisions that move products forward.
“
Fast solutions, focused on your goals
“Sobel provided a friendly, goal-oriented service with fast solutions. We look forward to working together on future projects.”
Andreas Kohl
CEO · Andratec
“
Broad expertise, real collaboration
“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.
FAQ
Questions we hear before every first call
Clear answers to what manufacturers ask us most about ANVISA registration for medical devices in Brazil.
Ask your question →What are the main regulations for medical devices in Brazil?
Medical devices are regulated by ANVISA. The core rules are RDC 751/2022 (classification, notification and registration), RDC 665/2022 (Good Manufacturing Practices) and the post-market rules for technovigilance. Electromedical and wireless devices may also need INMETRO and Anatel certification.
How are medical devices classified in Brazil?
Under RDC 751/2022, devices fall into four risk classes: Class I (low), II (medium), III (high) and IV (highest). The class depends on the intended use, invasiveness and duration of contact, and it defines the route to market. See where your device fits.
What is the difference between notification and registration?
Notification applies to Classes I and II and requires a simplified dossier. Registration applies to Classes III and IV and requires a complete technical dossier, B-GMP certification and technical review by ANVISA before approval.
Can a foreign manufacturer register a device in Brazil without a local company?
No. 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 keep control of your registrations and stay free to choose your distributors. Sobel offers this service through a qualified partner. Learn about our Registration Holder service.
What are ANVISA’s GMP requirements for medical devices?
Manufacturers of Class III and IV devices need ANVISA’s Good Manufacturing Practices certificate (B-GMP, or CBPF). Under RDC 850/2024, when it is granted through an MDSAP audit report, it is valid for four years, as long as the manufacturer stays in MDSAP. See our QMS, BGMP & MDSAP support.
Is INMETRO certification always required?
No. INMETRO certification applies to electromedical equipment within its scope, and Anatel certification to devices with radio transmission. Many devices need neither. We confirm what applies during the classification step. See INMETRO & Anatel.
Can I use my CE marking or FDA clearance to register in Brazil?
ANVISA does not accept CE marking or FDA clearance on their own, but much of your technical file, test reports and clinical evidence can be reused and adapted. For some higher-risk devices approved by equivalent foreign authorities, ANVISA also offers an optimized review route.
How long is an ANVISA registration valid?
A registration (Classes III and IV) is valid for 10 years and must be renewed. A notification (Classes I and II) has no expiry date, but changes to the product must still be reported to ANVISA.
Do labels and instructions for use need to be in Portuguese?
Yes. Labels and instructions for use must be in Brazilian Portuguese and follow ANVISA’s labeling requirements, including the registration or notification number once it is granted.
How can companies monitor approval status?
Applications can be followed in ANVISA’s online systems, and decisions are published in the Official Gazette (DOU). When Sobel manages your submission, we follow it for you and prepare the answer to each ANVISA requirement within the deadline, with your team’s input.
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