ANVISA RDC 751/2022: A Manufacturer's Guide to Brazilian Device Registration

This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. We explore its comprehensive framework, including the four-tier risk classification system, the distinct pathways for notification and registration, and its alignment with international standards like the IMDRF Table of Contents. The host also discusses modernized rules for Software as a Medical Device (SaMD) and what these significant changes mean for manufacturers seeking market access in Brazil. - What is ANVISA's RDC 751/2022 and why is it critical for device manufacturers? - How does Brazil classify medical devices by risk under the new regulation? - What is the difference between the 'notificação' and 'registro' pathways? - How does RDC 751/2022 align with global standards like the IMDRF? - Are there new rules for Software as a Medical Device (SaMD) in Brazil? - What previous regulations did RDC 751/2022 replace? - When did this new regulation become effective? - How can manufacturers leverage their existing technical files for Brazilian submission? Pure Global simplifies the complexities of global market access for MedTech and IVD companies. Our experts in Brazil provide end-to-end support for ANVISA registration under RDC 751/2022, from developing a regulatory strategy and compiling technical dossiers to acting as your official in-country representative. By leveraging advanced AI and a deep understanding of local requirements, we help you achieve faster, more efficient market entry. Let us manage the regulatory hurdles so you can focus on innovation. Contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.