Anvisa, the National Health Surveillance Agency, is the body responsible for regulating, authorizing, and supervising the entry and commercialization of products that impact health in Brazil.
In the case of medical devices, the agency’s role is crucial to ensure that only safe, effective, and quality technologies reach the market.
With a robust technical framework in constant modernization, the Brazilian regulatory system has been consolidating as one of the most structured in Latin America, and understanding its dynamics is essential for companies seeking to operate in the healthcare sector.
Classification and Risk Framework
The starting point of any regulatory process at Anvisa is the product framework, that is, the definition of its risk class.
This classification follows internationally harmonized criteria (based on IMDRF and RDC 751/2022), which consider factors such as:
- Intended use and mode of application
- Degree of invasiveness
- Duration of contact with the patient
Based on these criteria, medical devices are divided into four classes:
- Class I: low risk
- Class II: medium risk
- Class III: high risk
- Class IV: maximum risk
This stage is fundamental, as it defines the type of applicable regulatory process and the set of technical and documentary requirements demanded.
Regulatory Processes: Notification and Registration
After classification, devices follow two distinct paths:
Notification applicable to Class I and II products, of low and moderate risk. The process is simplified, focusing on proof of safety and efficacy through technical documentation, labeling, INMETRO and ANATEL certification (when applicable).
Registration applicable to Class III and IV products, of high and maximum risk. Requires the submission of complete technical dossiers, including validation reports, clinical performance, risk analysis, and proof of compliance.
In both cases, the manufacturer must maintain a legal representative in Brazil, responsible for petitioning and liaison with Anvisa.
Good Manufacturing Practices Certification (CBPF)
For Class III and IV devices, Good Manufacturing Practices Certification (CBPF) is a mandatory requirement.
Issued by Anvisa after an audit of the manufacturer, this certification proves that the company adopts quality systems minimally aligned with RDC 751/2022.
CBPF is one of the most critical stages of the process, as it ensures that the product is manufactured under rigorous quality, safety, and traceability controls.
Modernization and Regulatory Convergence
In recent years, Anvisa has been implementing modernization initiatives that bring Brazil closer to international standards.
Among the main ones are:
- Digitalization of petitioning and technical analysis processes, reducing average processing time
- Adoption of international recognition practices, aligned with IMDRF
- Active participation in global harmonization forums, which increases predictability for international manufacturers
These measures reinforce Anvisa’s commitment to efficiency and transparency, without giving up health safety, an essential balance to stimulate innovation.
Post-Market and Registration Maintenance
Regulatory responsibility does not end with approval.
After granting registration or notification, the holder must comply with post-market obligations, such as:
- Monitoring adverse events and technical complaints
- Periodic updating of technical information and labeling
- Renewal of registrations within established deadlines
- Maintenance of traceability and quality control of commercialized products
This continuous monitoring ensures that the product remains compliant throughout its entire life cycle in the market.
Conclusion: Regulation as a Foundation for Sustainable Growth
Anvisa’s regulatory system is, above all, an instrument of trust.
For manufacturers who understand it, it becomes a strategic asset, capable of boosting brand credibility and enabling entry into one of the largest healthcare markets in Latin America.
At Brisa, we work to make this process more predictable, efficient, and safe, connecting innovation to regulatory compliance.
Because, in the end, understanding regulation is the first step to expanding solidly in Brazil.
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
