Anvisa Medical Device Approval Solutions
Achieve Anvisa medical device approval with expert guidance! Sobel supports your company with tailored expertise in Anvisa compliance in Brazil, covering device classification, technical documentation, GMP and Inmetro processes.
Who we support in the Brazilian Medical Device market
Medical Device Manufacturers
Seeking regulatory support to navigate Anvisa medical device classification, documentation, and approval.
International Companies
Requiring local representation and assistance with Anvisa medical device regulations and submissions.
Importers and Distributors
Needing guidance on labeling, documentation, and access to the Anvisa medical device registration database.
Regulatory Affairs Teams
Looking for expert partners to manage technical dossiers, GMP, and post-market compliance.
Anvisa Compliance in Brazil: What Companies Need to Know
The Brazilian medical device market offers strong opportunities, but companies must align with Anvisa’s regulations to access it. Many manufacturers face similar doubts when preparing submissions and managing compliance:
What are the main regulations for medical devices in Brazil?
Medical devices are regulated by Anvisa under RDC 751/2022, which defines classification and regulatory routes, and RDC 848/2024, which sets rules for electronic submissions and document management. Compliance with these frameworks is essential for market approval.
What is the difference between notification and registration?
Devices classified as Class I and II usually follow the notification process, which requires a simplified submission. Class III and IV devices must go through full registration, including detailed technical dossiers and safety evidence. Sobel helps companies prepare and submit documentation correctly for both pathways.
What are Anvisa’s GMP requirements for medical devices?
Manufacturers must comply with Good Manufacturing Practices (GMP), verified through Anvisa audits or international agreements. GMP certification is a prerequisite for higher-risk device registration. Sobel provides support in aligning your QMS with these requirements, along with training programs to prepare your team for audits and regulatory expectations.
Is Inmetro certification always required?
Not all devices need Inmetro approval. This certification applies to specific categories, such as electromedical equipment. Sobel helps determine if your device requires Inmetro and guides you through the certification process.
How can companies monitor approval status?
Approved or notified devices appear in the Anvisa medical device registration database. Sobel supports you in monitoring submissions, managing updates through systems like Anvisa Consulta AFE, and maintaining regulatory traceability.
Sobel is more than a consultant — we are your long-term partner in Anvisa compliance in Brazil, supporting your company through every stage of the device lifecycle.
How Sobel supports Anvisa compliance in Brazil
Bringing a medical device to Brazil requires navigating Anvisa’s complex framework, from RDC 751/2022 and RDC 848/2024 to GMP certification and, in some cases, Anatel or Inmetro approval. These steps demand detailed preparation, accurate documentation, and constant monitoring.
Sobel provides hands-on guidance to make this process more efficient. Our consultants assist with risk classification, compilation of technical dossiers, electronic submissions, biological and clinical evaluations, and toxicological risk assessments.
We also support QMS alignment and training to prepare teams for audits and long-term compliance, and Sobel can act as your Brazilian Registration Holder.
By partnering with Sobel, your company reduces delays, secures a reliable compliance pathway, and gains freedom to focus on product development and growth in Brazil’s healthcare market.
Regulatory expertise for medical devices in Brazil
We provide tailored services to help your company meet Anvisa’s requirements with clarity and efficiency.
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Biological Evaluation
Complete Biological Evaluation for devices, aligned with ISO 10993 for safety & compliance.
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Clinical Evaluation
Clinical Evaluation aligned with Guidance nº 31/2020 – version 2, ensuring device safety.
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Brazilian Registration Holder
Navigate market access in Brazil with Sobel as your device registration holder.
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Medical Device Registration and Notification
Notification, registration, and updates under RDC 978/2025 and RDC 658/2022.
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Inmetro or Anatel Certification Support
Support for Anatel and Inmetro certification Brazil.
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Medical Devices Regulatory Training
Expert training programs on ISO 13485, MDSAP, ISO 10993 and Anvisa’s RDCs.
Unlocking opportunities in Brazil’s medical device market
Brazil’s medical device market is competitive, and navigating Anvisa’s requirements can be time-consuming. Sobel helps transform this challenge into an opportunity, giving your company the clarity and resources needed to reach the market faster and stronger.
By choosing Sobel, you gain:
Complete guidance for Anvisa compliance in Brazil, from strategy to approval.
Lower risk of delays, non-conformities, or regulatory setbacks.
Expertise in dossiers, GMP, INMETRO, and post-market obligations.
Local support through Registration Holder services and regulatory representation.
Expand with confidence in Brazil’s healthcare market
Sobel manages the regulatory complexity, from documentation to Registration Holder services, so you can focus on innovation and growth.
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