Anvisa Medical Device Registration and Notification in Brazil
Expanding your medical device business into Brazil represents a promising opportunity — but navigating Anvisa’s regulatory system can be complex. At Sobel, we simplify this journey. Our team provides full regulatory support for Anvisa medical device registration, notification, change or rectification.
- Foreign manufacturers entering the Brazilian market for the first time.
- Local distributors responsible for Anvisa registration or notification.
- Companies seeking to expand their product portfolio under existing licenses.
- Regulatory teams that require support with Anvisa.
Expand your medical device business into Brazil with confidence. Our process for Anvisa medical device registration covers every technical requirement defined by Anvisa.
Why do you need this service?
The Brazilian regulatory pathway for medical devices involves detailed technical requirements and constant updates from Anvisa.
Without local expertise, companies often face long delays, repeated submissions, or even rejections that increase costs and postpone market entry.
With Sobel’s specialized support, your documentation is prepared according to the latest Anvisa framework (such as RDC 978/2025 and RDC 658/2022).
Anvisa medical device registration requirements in Brazil
Anvisa medical device registration in Brazil requires manufacturers to classify the device according to risk class, prepare technical documentation aligned with RDC 751/2022 and related resolutions, obtain Good Manufacturing Practices (GMP) certification when applicable, and submit notification or registration dossiers through the Anvisa electronic system. Maintaining regulatory updates and post-market compliance is also required to ensure continued commercialization.
From risk classification to dossier submission:
Which service applies to your case?
Different regulatory paths exist within Anvisa medical device registration and notification. Understanding which one applies to your product is key to defining the correct strategy.
Medical Device Notification
For Class I and II devices (software, equipment, or material) that present low risk. Includes checklist review, document preparation, dossier submission, labeling, and follow-up until DOU publication.
Medical Device Registration
For Class III and IV devices (equipment, materials, and implantables) requiring full technical evaluation. Involves detailed dossier compilation, clinical and risk management documentation, and Anvisa petition submission.
Notification or Registration Change
When an already approved product undergoes updates (e.g., design, labeling, or manufacturing). Covers amendment documentation, new comparative tables, and re-submission to Anvisa for approval.
Medical Device Rectification
When Anvisa requests corrections after submission. Focused on form correction, test guidance, and follow-up until closure of the agency’s request.
Not sure how to register your medical device product with Anvisa?
Sobel’s regulatory consultants will assess your current documentation and determine whether your device requires notification, registration, or a change process!
Related
Services
At Sobel, we guide companies through the complete process of Anvisa medical device registration and notification. Explore other Anvisa Compliance in Brazil solutions that complement this service:
Biological evaluation in line with ISO 10993 and Anvisa requirements.
Navigate market access in Brazil with Sobel as your device registration holder.
A compliant market entry with Sobel
Achieving an Anvisa medical device registration or notification is more than a bureaucratic step — it’s a strategic requirement for sustainable market access in Brazil.
With a team specialized in Anvisa and deep knowledge of Brazilian legislation, Sobel provides clarity, technical precision, and reliable follow-up at every stage.
Take the first step toward a seamless registration process!
1. What is Anvisa medical device registration or notification?
It’s the regulatory process required by the Brazilian Health Regulatory Agency (Anvisa) to authorize the commercialization of medical devices in Brazil. All products must comply with the applicable resolutions, such as RDC 978/2025 and RDC 658/2022, which define classification criteria, documentation, and technical evaluation steps.
2. What’s the difference between notification and registration at Anvisa?
Notification applies to Class I and II devices, considered low to medium risk. The process is simplified and faster. Registration applies to Class III and IV devices, which require detailed technical and clinical evaluation before approval. Sobel helps determine which route applies to your product and regulatory pathway assessment.
3. How do I register a medical device with Anvisa?
To understand how to register your product with Anvisa, the process begins with device classification, dossier preparation, and submission through the Anvisa system (Solicita). The required documents include technical descriptions, risk analysis, and more! Sobel manages the entire submission, follow-up, and publication process for an efficient and compliant Anvisa registration.
4. What is AFE and why do I need it?
The Anvisa AFE (Autorização de Funcionamento de Empresa) is the company license required before any product registration. Without it, manufacturers or importers cannot legally operate in the Brazilian health market.
5. How long does Anvisa registration take?
Processing time depends on the device class and Anvisa’s current queue. Sobel’s proactive follow-up helps reduce potential delays and maintain document alignment.
6. My registration is already approved. When should I request a change or rectification?
A change is required when updating product characteristics such as labeling, design, or manufacturing site. A rectification applies when Anvisa identifies formal issues during review and requests corrections. Sobel supports both notification and registration changes as well as product rectifications, managing communication with the agency until approval.
