『Brazil ANVISA Recognized Technical Standards: New Lists for Medical Devices』のカバーアート

Brazil ANVISA Recognized Technical Standards: New Lists for Medical Devices

Brazil ANVISA Recognized Technical Standards: New Lists for Medical Devices

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概要
 On October 22, 2026, Brazil's ANVISA published three new workbooks of recognized technical standards for medical devices. This episode explores the three new lists—transversal standards, orthopedic implantable materials, and health-use materials—and explains how manufacturers can voluntarily use them to create a presumption of conformity with Brazil's essential safety and performance requirements. We discuss how leveraging these standards can streamline the preparation and review of technical documentation, simplifying market access for new and existing products. Key Questions: - What are ANVISA's newly recognized technical standards published on October 22, 2026? - How do these standards relate to Brazil's core medical device regulation, RDC 751/2022? - What are the three new workbooks of standards and what do they cover? - How can using these voluntary standards create a 'presumption of conformity'? - Which types of medical devices are most affected by the new lists? - What is the difference between the 'transversal,' 'orthopedic materials,' and 'health-use materials' lists? - What practical steps should regulatory and quality teams take in response to this announcement? - Can declaring conformity to these standards help speed up the review of a technical dossier in Brazil? Sources: - https://www.pure-global.com/news/brazil-anvisa-publishes-three-recognized-device-standards-lists How Pure Global can help: Pure Global provides end-to-end regulatory consulting to help MedTech companies achieve and maintain market access in over 30 countries, including Brazil. Our experts can help you navigate ANVISA's requirements, leverage recognized technical standards to build a robust technical dossier, and act as your Brazil Registration Holder. We combine local expertise with advanced AI tools to streamline submission preparation, post-market surveillance, and regulatory intelligence, helping you get to market faster. To learn more about our services, visit https://pureglobal.com, contact us at info@pureglobal.com, or explore our free AI tools and device database at https://pureglobal.ai.
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