Our solutions
Bring your medical device to the Brazilian market with confidence! Count on our expert support to meet Anvisa’s requirements, from risk classification to Good Manufacturing Practices (GMP) certification. We simplify the regulatory process so you can focus on what matters most: innovating and growing your business.
Anvisa compliance
Regulatory Compliance Solutions for the Brazilian Medical Device Market
The Brazilian medical device market is rapidly expanding, creating new opportunities for innovation and growth. To succeed, manufacturers must comply with Anvisa regulations, including rigorous approval processes and quality standards. Our experts provide strategic guidance to help you navigate Brazil’s regulatory framework. With our support, you can overcome regulatory hurdles and establish a strong presence in this dynamic market.
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.
Training
Training and adjustments for RDC 751/2022, MDR 2017/745, RDC 665, and ISO 13485.
Entering the Brazilian medical device market requires a solid understanding of Anvisa regulations and a clear regulatory strategy. Our team helps you navigate RDC 848/2024 and RDC 751/2022 to meet all requirements.
We help with accurate submissions, anticipating possible regulatory challenges and simplifying documentation. Our risk assessments, in line with the ISO 10993 series, MDR 2017/745 and Anvisa guidelines, evaluate biological, clinical and toxicological risks to help ensure the safety and performance of your device.
We guide you through preparing technical dossiers that comply with Anvisa’s standards. We also provide ongoing support to manage post-market obligations, adapt to regulatory updates, and maintain compliance smoothly.
Whether launching a new product or expanding your presence in Brazil, we provide the strategic support you need to move forward confidently.
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