For every medical device entering the Brazilian market, classification is the first and most critical regulatory step. This process determines not only how the device will be evaluated by Anvisa (Brazil’s National Health Surveillance Agency) but also the scope, cost, and timeline of its approval.
In other words, accurate classification is the foundation of an efficient regulatory strategy. Misclassification, on the other hand, can lead to delays, noncompliance, or even market withdrawal.
The Logic Behind Classification
Anvisa’s classification framework follows international standards harmonized with the International Medical Device Regulators Forum (IMDRF). It is based on the principle of risk management: the higher the potential risk to the patient or user, the stricter the regulatory requirements.
Each device is classified into one of four risk classes:
- Class I: Low risk (e.g., non-invasive instruments or simple medical accessories)
- Class II: Medium risk (e.g., dental handpieces, diagnostic reagents)
- Class III: High risk (e.g., infusion pumps, orthopedic implants)
- Class IV: Maximum risk (e.g., pacemakers, heart valves, critical monitoring systems)
This classification defines whether the device will go through a notification (cadastro) or a registration (registro) process, as well as whether Good Manufacturing Practice (CBPF) certification will be required.
Key Criteria Considered by Anvisa
When determining the risk class, Anvisa evaluates a combination of technical and clinical factors, including:
- The intended purpose and mechanism of action of the device;
- Its level of invasiveness and duration of contact with the body;
- Whether it delivers energy, drugs, or substances to the patient;
- The potential impact on diagnosis, therapy, or patient outcomes;
- Whether the device is active, implantable, or software-based (SaMD).
These parameters must be carefully documented and justified in the technical dossier. A well-structured rationale can make the difference between a smooth submission and one that requires multiple rounds of clarification.
Why Proper Classification Is Strategic
Correct classification goes beyond regulatory compliance; it is a strategic decision. It directly influences:
- Documentation requirements and submission complexity;
- Costs and timelines associated with the approval process;
- Post-market obligations, such as vigilance and renewal;
- Market access opportunities for expansion in Latin America.
By defining the right path early, manufacturers can plan production, importation, and commercialization with far greater predictability.
Brisa’s Expertise in Classification and Regulatory Strategy
At Brisa, we support manufacturers and distributors in accurately classifying their products and designing the most efficient regulatory pathway for entry into Brazil. Our team analyzes each device from a technical, legal, and clinical perspective, ensuring full alignment with Anvisa’s expectations and IMDRF standards.
Through our integrated regulatory ecosystem, we combine classification, registration, importation, and commercialization under a unified strategy, enabling our clients to bring innovation to the market safely and efficiently.
Conclusion: Every Successful Approval Starts with the Right Classification
In a market as dynamic and demanding as healthcare, success begins with precision. A clear understanding of classification not only ensures compliance but also accelerates innovation, protects patients, and strengthens trust.
At Brisa, we help global manufacturers navigate this first and most decisive step because every successful regulatory journey starts with the right classification.
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