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Pure Global: Brazil's RDC 751 Quagmire - A MedTech Survival Guide.
This week on LATAM MedTech Insights, we dissect the ongoing regulatory shake-up in Brazil. ANVISA's RDC 751/2022 is now in full force, and medical device manufacturers are facing a complex new reality. We unpack the critical changes, moving beyond the headlines to explore the on-the-ground impact of the new technical dossier structure and reclassification rules.
We explore the long-term vision behind this push for harmonization with global standards and contrast it with the immediate, resource-intensive hurdles companies must overcome. This episode is essential listening for any MedTech professional with stakes in the Brazilian market.
For example, consider a successful US-based IVD manufacturer whose product has been on the Brazilian market for years. Under RDC 751, their device is now in a higher risk class and their existing technical file is obsolete. How can they possibly compile, translate, and submit a completely new dossier that meets the stringent new structure before their current license expires and their multi-million dollar revenue stream is cut off?
What You'll Learn:
- What are the three most common deficiencies ANVISA is finding in new RDC 751 submissions?
- How does the new technical file structure differ from the US FDA 510(k) or EU MDR requirements?
- Is your current Brazil Registration Holder (BRH) equipped to handle these complex new requirements?
- What's the biggest mistake companies make when updating their risk management files for ANVISA?
- Could this regulatory challenge actually be a strategic opportunity to leapfrog competitors?
- How will Brazil's alignment with the IMDRF framework impact your expansion plans in other LATAM countries?
At Pure Global, we specialize in transforming regulatory complexity into market opportunity. Our team of local experts in Brazil, combined with our AI-powered data tools, provides end-to-end solutions for MedTech and IVD companies. Whether it's conducting a gap analysis for RDC 751, managing technical dossier submissions, or acting as your official local representative, we streamline your path to market. Don't let regulatory changes disrupt your business. Contact us for a consultation at [email protected] or visit https://pureglobal.com/ to learn more.
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By Ran ChenThis week on LATAM MedTech Insights, we dissect the ongoing regulatory shake-up in Brazil. ANVISA's RDC 751/2022 is now in full force, and medical device manufacturers are facing a complex new reality. We unpack the critical changes, moving beyond the headlines to explore the on-the-ground impact of the new technical dossier structure and reclassification rules.
We explore the long-term vision behind this push for harmonization with global standards and contrast it with the immediate, resource-intensive hurdles companies must overcome. This episode is essential listening for any MedTech professional with stakes in the Brazilian market.
For example, consider a successful US-based IVD manufacturer whose product has been on the Brazilian market for years. Under RDC 751, their device is now in a higher risk class and their existing technical file is obsolete. How can they possibly compile, translate, and submit a completely new dossier that meets the stringent new structure before their current license expires and their multi-million dollar revenue stream is cut off?
What You'll Learn:
- What are the three most common deficiencies ANVISA is finding in new RDC 751 submissions?
- How does the new technical file structure differ from the US FDA 510(k) or EU MDR requirements?
- Is your current Brazil Registration Holder (BRH) equipped to handle these complex new requirements?
- What's the biggest mistake companies make when updating their risk management files for ANVISA?
- Could this regulatory challenge actually be a strategic opportunity to leapfrog competitors?
- How will Brazil's alignment with the IMDRF framework impact your expansion plans in other LATAM countries?
At Pure Global, we specialize in transforming regulatory complexity into market opportunity. Our team of local experts in Brazil, combined with our AI-powered data tools, provides end-to-end solutions for MedTech and IVD companies. Whether it's conducting a gap analysis for RDC 751, managing technical dossier submissions, or acting as your official local representative, we streamline your path to market. Don't let regulatory changes disrupt your business. Contact us for a consultation at [email protected] or visit https://pureglobal.com/ to learn more.