Overview
To market medical devices in Brazil — from surgical materials to diagnostic equipment — companies must register them with Anvisa, the National Health Surveillance Agency. Brazil classifies these products into four risk classes (I to IV), which determine the level of regulatory control and documentation required. In this article, you’ll learn how Brazil defines medical device risk classes and what is required to bring each type to market.
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Introduction
Medical devices are essential for diagnosis, treatment, and rehabilitation. For this reason, Brazil enforces strict regulatory oversight to ensure the safety, efficacy, and quality of these products.
A critical step in the registration process is determining the correct risk class. The risk class influences the type of process required — notification, listing (cadastro), or full registration (registro) — as well as the depth of technical analysis conducted by Anvisa.
The regulatory framework is defined by RDC 751/2022, currently the main regulation for medical devices in Brazil.
How is a Product’s risk Class Determined
Anvisa’s classification is based on internationally accepted principles (GHTF) and considers:
- Duration and level of contact with the human body
- Invasiveness
- Intended purpose (diagnostic, therapeutic, aesthetic)
- Whether the product is active or passive
- Criticality of the anatomical site affected
Risk Classes: From I to IV:
Risk Class | Risk Level | Regulatory Path | Examples |
Class I | Low Risk | Notification (Cadastro) | Surgical gloves, bandages |
Class II | Medium Risk | Notification (Cadastro) | Blood pressure monitors, dental chairs |
Class III | High Risk | Registration (Registro) | Infusion pumps, implantable devices |
Class IV | Very High Risk | Registration (Registro) | Heart valves, pacemakers |
Class I – Low Risk
Examples: simple wound dressings, non-invasive thermometers, surgical scissors.
Requirements:
- Online listing through Anvisa’s electronic system
- Simplified documentation
- Automatic approval (no prior Anvisa review)
✅ Fast-track listing process with minimal technical complexity
🔸 Class II – Moderate Risk
Examples: wheelchairs, phototherapy lamps, electric scalpels.
Requirements:
- Online listing (cadastro)
- Technical documentation and user manuals
- Labeling according to Brazilian rules
- Manufacturer’s quality assurance documentation
⚠️ Moderate level of oversight, more detailed than Class I
🔴 Class III – High Risk
Examples: pacemakers, orthopedic implants, MRI scanners.
Requirements:
- Full registration (registro)
- Complete technical dossier (including safety and performance data)
- GMP certification required (Good Manufacturing Practices)
- Clinical data, where applicable
- Post-market surveillance plan
🔍 Detailed technical analysis and strict documentation review by Anvisa
🔴 Class IV – Very High Risk
Examples: implantable defibrillators, active implantable devices, drug-eluting stents.
Requirements:
- Full registration (registro)
- Extensive technical documentation
- Robust clinical evidence
- Mandatory GMP certification
- Biocompatibility studies, sterilization validation, traceability
🚨 Highest level of regulatory scrutiny
⏳ Average Processing Times
Class | Process Type | Estimated Time |
I | Listing | Immediate |
II | Listing | Up to 30 business days |
III | Registration | ~ 180 business days |
IV | Registration | 180 + business days |
What’s Required for Each Class?
Requirement | Class I/II (Cadastro) | Class III/IV (Registro) |
Technical Dossier | Simplified | Full dossier with detailed testing |
Clinical Evaluation | Not required | Required (may include clinical data or equivalence) |
Good Manufacturing Practice (GMP) | Exempt for I, Required for II | Required |
Label and Instructions | Mandatory | Mandatory |
ANVISA Review | Administrative check | Full technical review |
⚠️ Common Pitfalls to Avoid
❌ Incorrect risk classification (can invalidate the process)
❌ Incomplete or outdated documentation
❌ Lack of GMP certification (required for Class III and IV)
❌ Missing clinical data or performance evidence
❌ Noncompliance with international standards (IEC, ISO)
Conclusion
Correctly classifying your medical device’s risk level is the first and most important step in a successful registration process with Anvisa. Each class has its own set of requirements that directly affect the timeline, cost, and complexity of the process.
Companies that understand and comply with these requirements gain faster access to the Brazilian market, reduce regulatory risks, and ensure safety for patients and healthcare providers.
Key Benefit
To Streamline the Process:
- Check the risk classification table in RDC 751/2022 (Annex II)
- Maintain updated technical documentation in alignment with global standards (ISO 13485, IEC 60601, etc.)
- Consider hiring regulatory consultants experienced with the Brazilian market
- Monitor regulatory updates from Anvisa and other international agencies
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.