Our solutions
Bring your medical device to the Brazilian market with strategic support from Sobel. We help your company navigate Anvisa medical device regulations, from risk classification and technical dossier preparation to Good Manufacturing Practices (GMP) and INMETRO certification when applicable. Our team supports you through every step of the regulatory process, helping streamline compliance and allowing you to focus on innovation, product development, and growth in the Brazilian healthcare market.
Anvisa Compliance and Medical Device Registration in Brazil
Regulatory Compliance Solutions for the Brazilian Medical Device Market
The Brazilian medical device market is one of the fastest-growing in Latin America, offering high potential for international manufacturers.
To access this opportunity, companies must comply with Anvisa’s complex regulatory framework, which includes: adhering to RDC 751/2022 for device classification and regulatory routes, following RDC 848/2024 for electronic submissions and document management, submitting accurate documentation for notification (Class I & II) or registration (Class III & IV), meeting GMP requirements issued by Anvisa or international agreements, complying with labeling regulations in Portuguese and obtaining INMETRO approval for specific product categories.
Sobel supports you in developing a tailored regulatory strategy that minimizes delays and maximizes market access efficiency.
Our Services in Regulatory Compliance Solutions
Regulatory expertise to help you navigate Anvisa requirements with confidence. Explore the key steps of the registration process for medical devices and how Sobel can support you.
Pre-Registration Setup
Risk & Safety Assessment
Clinical and Safety Evaluations
Documentation & Submission
Post-Submission Compliance
Regulatory Affairs Support
Navigate regulatory affairs with our service, ensuring compliance with RDC 751/2022.
Quality Management Support
Align your QMS with RDC 665/2022 through expert support in audits, processes & standards.
Risk Management
Manage device risks with ISO 14971 support, including risk analysis and control measures.
Biological Evaluation
Complete Biological Evaluation for devices, aligned with ISO 10993 for safety & compliance.
Clinical Evaluation
Clinical Evaluation aligned with Guidance nº 31/2020 – version 2, ensuring device safety.
Submission File Elaboration
Prepare a robust technical dossier aligned with RDC 751/2022, supporting market approval.
Toxicological Risk Assessment
Aligned with RDC 848/2024, mitigating risks for market entry while ensuring product safety.
Brazilian Registration Holder
Navigate market access in Brazil with Sobel as your device registration holder.
Entering the Brazilian medical device market requires a solid understanding of Anvisa regulations and a clear regulatory strategy.
Our regulatory consultants assist with the preparation and organization of the technical dossier (dossiê técnico), aligning with Anvisa’s standards and your device’s classification. We also conduct biological and toxicological risk assessments in accordance with ISO 10993, Anvisa guidelines, and references such as MDR 2017/745, enhancing the quality and acceptance of your submission.
Beyond registration, we offer support for post-market obligations, such as updates, renewals, vigilance reports, and adaptation to changing regulatory requirements. We help ensure your company maintains full compliance throughout the product lifecycle in Brazil.
Whether you are launching a new product or expanding your operations in Brazil, Sobel offers the strategic insight and regulatory expertise needed to navigate the Anvisa approval process effectively and build a strong, compliant presence in the country.
Latest articles
Discover trends, tips, and expert insights to keep you ahead.
The Essential Role of PMS in Ensuring Compliance with MDR 2017/745: A Professional Guide
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
MDR 2017/745 vs ISO 13485: Decoding Quality Management Requirements
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Success in Product Design: The Importance of ISO 14971 in Medical Device Risk Management
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
