『Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success』のカバーアート

Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success

Navigating Brazil's ANVISA RDC 751 & RDC 830: A Pure Global Guide to LATAM MedTech & IVD Market Access Success

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 This episode of LATAM MedTech Insights dives deep into the most significant regulatory shift in the region's largest market: Brazil. We explore ANVISA's new regulations, RDC 751/2022 for medical devices and RDC 830/2023 for IVDs, which align Brazil's framework more closely with international standards like the EU MDR. This is a critical update for any MedTech company looking to enter or expand its footprint in Latin America. We unpack what this harmonization means in practical terms. Consider this: a medical device company with CE marking for its product previously faced a complex, 18-month process to reformat its entire technical dossier for Brazil. Today, that same dossier can be leveraged to gain market access in a fraction of the time and cost. This episode explains how you can capitalize on this change and avoid common pitfalls during the transition. Key Takeaways: * How does Brazil's new RDC 751/2022 fundamentally change the market entry strategy for your medical device? * What is the critical June 1, 2024 deadline for IVD manufacturers under RDC 830/2023 and what must be done? * Can your existing EU or FDA technical documentation be used for a submission in Brazil now? * How does Brazil's regulatory shift compare to changes happening in Mexico and Colombia? * What are the key differences between the old 'cadastro' system and the new 'notificação' pathway? * Why is having an expert local representative in Brazil more crucial than ever under these new rules? * What are the most common mistakes companies make when transitioning their legacy products to the new regulations? Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline your global market access, from initial strategy to post-market surveillance. To navigate the complexities of the LATAM market, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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