Are you a medical device executive looking to understand how medical devices are classified in Brazil? This comprehensive guide will walk you through ANVISA’s classification system and requirements, helping you navigate the Brazilian regulatory landscape effectively.
The Brazilian Regulatory Framework
Brazil’s medical device market, regulated by ANVISA (Brazilian Health Regulatory Agency), operates under specific guidelines that ensure product safety and efficacy. Understanding these classifications is crucial for successful market entry and regulatory compliance.
Risk Classification System
ANVISA’s medical device classification follows both risk categories and specific classification rules as defined in RDC 751/2022:
Class I (Low Risk)
- Notification Process
- Current Average Timeline: 30-60 days
- Generally applies to non-invasive devices under Rules 1-4
Class II (Medium Risk)
- Notification Process
- Current Average Timeline: 30-60 days
- Often includes certain invasive devices under Rules 5-8
Class III (High Risk)
- Full Registration Process
- Current Average Timeline: 8-12 months
- Typically covers active devices under Rules 9-13
Class IV (Maximum Risk)
- Enhanced Registration Process
- Current Average Timeline: 08-12 months
- Often involves special rules (14-22)
Classification Rules Structure
The 22 classification rules are organized into four main categories:
- Non-invasive Devices (Rules 1-4)
- Covers devices with external patient contact
- Includes devices for storing/channeling substances
- Invasive Devices (Rules 5-8)
- Addresses surgically invasive devices
- Considers duration of body contact
- Active Devices (Rules 9-13)
- Covers devices requiring energy source
- Includes diagnostic and therapeutic devices
- Special Rules (Rules 14-22)
- Addresses specific cases like medicinal substances
- Covers unique technologies and applications
Note: Detailed classification rules can be found in Annex I of RDC 751/2022. Analysis timeframes are estimates and may vary based on ANVISA’s current workload.
GMP Requirements and MDSAP Considerations
For higher-risk devices (Classes III and IV), manufacturers must demonstrate compliance with Good Manufacturing Practices (GMP). Brazil participates in the Medical Device Single Audit Program (MDSAP), which can streamline the certification process for international manufacturers. To learn more about this topic, click here.
Software as a Medical Device (SaMD)
With the increasing prevalence of digital health solutions, ANVISA has specific requirements for Software as a Medical Device (SaMD). These products must undergo classification and registration based on their intended use and potential risk.
Laboratory Developed Tests Considerations
For manufacturers dealing with laboratory developed tests, additional requirements apply under specific ANVISA regulations. These products require special attention to classification and validation requirements.
Registration Process and Documentation
The registration process varies by classification:
- Classes I and II typically follow a simplified notification process
- Classes III and IV require complete registration with extensive technical documentation
- All classes must provide Instructions for Use (IFUs) and Label in Portuguese .
Market Access Strategy
Successful market entry requires:
- Understanding of RDCs (ANVISA’s regulatory requirements)
- Proper device classification
- Comprehensive technical documentation
- Quality system certification
- Local representation in Brazil
For expert guidance on medical device registration and regulatory compliance in Brazil, contact Brisa Advisors for specialized regulatory support.
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
