『Pure Global: Brazil's ANVISA Shift & The Hidden Dossier Trap』のカバーアート

Pure Global: Brazil's ANVISA Shift & The Hidden Dossier Trap

Pure Global: Brazil's ANVISA Shift & The Hidden Dossier Trap

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概要

 This week, we dive into a major regulatory shift in Brazil that is catching international MedTech companies off guard. ANVISA's RDC 751/2022 is entering a critical new phase, and the latest clarifications on technical dossier requirements are creating significant hurdles for manufacturers seeking market access. We break down what these changes mean and why your existing FDA or CE mark documentation may no longer be enough. We explore the challenges through a common scenario. Imagine a successful European MedTech company, confident in their CE-marked diagnostic tool, targeting Brazil for their next big expansion. They suddenly face a submission rejection from ANVISA due to "insufficient clinical data" under the new RDC 751 rules. Their launch is now stalled, competitors are gaining ground, and they face the costly, time-consuming task of generating new evidence for a market they don't fully understand. Key Takeaways: * What is the crucial difference between an EU technical file and a Brazilian dossier under RDC 751? * Why is ANVISA's new classification system causing unexpected delays for device makers? * Is your clinical data robust enough for Brazil's heightened scrutiny? * What is the number one documentation mistake companies make when submitting to ANVISA? * How can you turn Brazil's tough regulatory environment into a competitive advantage? * Why might your risk management file be non-compliant, even if it was accepted elsewhere? * What are the unwritten rules for expediting your registration process in Brazil? Navigating the complexities of global markets like Brazil is what we do best. Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline market access. Don't let regulatory hurdles derail your expansion. Contact us at info@pureglobal.com or visit https://pureglobal.com/ to learn how we can secure your entry into Latin America.
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