Navigating the Brazilian medical device market is essential for manufacturers looking to expand their reach. At the heart of Brazil’s regulatory landscape for medical devices is ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian Health Regulatory Agency. ANVISA is responsible for ensuring the safety, efficacy, and quality of medical devices within Brazil.
Recently, ANVISA has made significant updates to its regulations to align with global standards and accommodate the rapid advancement in medical technologies. The key regulation to be aware of is RDC 751/2022, which was introduced to streamline the registration process for medical devices 2. This regulation outlines risk classification rules, labeling requirements, and instructions for use (IFU), along with detailed procedures for notification, registration, amendment, revalidation, and cancellation of medical devices. It serves as a comprehensive guide for manufacturers to navigate the regulatory requirements efficiently.
Additionally, ANVISA has approved a new resolution addressing essential safety and performance requirements for medical devices and in vitro diagnostic devices (IVD), revising the previous RDC 546/2021. This update, reflecting on the advancements in healthcare technology, aims to facilitate manufacturers’ efforts in providing comprehensive evidence and studies to support product registration requests 1.
Moreover, with the introduction of Normative Instruction (IN) 290/2024, ANVISA now acknowledges analyses conducted by equivalent foreign regulatory authorities, such as those in Australia, Canada, the United States, and Japan. This harmonization is a significant step towards expediting the evaluation process, ensuring that safe and effective medical devices reach the Brazilian market more swiftly 3.
In summary, ANVISA’s evolving regulatory framework, especially with RDC 751/2022 and the new safety and performance requirements, marks a significant shift towards global alignment and technological advancement in the Brazilian medical device market.
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Navigate the complex world of regulatory affairs with our comprehensive Regulatory Service. From strategic planning to gap analysis and continuous support, we ensure alignment with RDC 751/2022 and related regulations for a seamless business operation.
Sobel Consultancy’s Quality Management Support offers unparalleled assistance in harmonizing your existing quality management system with the requirements of the Brazilian RDC 665/2022. Whether internal audits, analysis of existing processes, implementation of international standards or a helping hand with daily work? Our experts are ready and waiting.
Manage medical device risks effectively with ISO 14971-based Risk Management Support. Expert planning, comprehensive risk analysis, and effective control measures are at your disposal. A final report evaluates overall risk, ensuring safety and compliance.
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Trust our experts to deliver what you need to be compliant and demonstrating your device’s safety and performance.
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Secure your place in the Brazilian market with Sobel Consultancy’s Brazilian Registration Holder.
Every foreign manufacturer needs a representative in Brazil. The representative holds the registration and represents him in vigilance issues.
Specialized in medical device representation, we strengthening your global footprint.
Unleash your potential in the complex realm of medical devices through our comprehensive training programs.
Our curriculum is designed to cater to your specific requirements, ranging from acquiring a deep understanding of RDC 751/2022, MDR 2017/745 fundamentals or conducting meticulous toxicological evaluations.
Rest assured, our training programs are tailored to meet the highest professional standards in the industry.
