17 March 2026
Pure Global: Cracking Brazil's New IVD Code Under ANVISA's RDC 830
LATAM MedTech Insights
About
In this episode of LATAM MedTech Insights, we break down the critical new IVD regulation in Brazil, RDC 830/2023. This isn't just another update; it's a complete overhaul that aligns In-Vitro Diagnostic devices with the stringent framework of the general medical device regulation, RDC 751/2022, creating a new set of rules and unexpected hurdles for manufacturers.
We uncover the hidden complexities within this harmonization effort, from reclassifying your product's risk level to meeting demands for more robust clinical evidence and local performance data. This shift signals ANVISA's move towards a more demanding and localized regulatory system, making prior foreign approvals less of a guarantee for market access.
A specific case involves a European diagnostics firm whose Class C diabetes monitoring IVD, previously accepted with its existing technical file, now faces rejection. The reason is a buried requirement in the new framework demanding stability studies validated against Brazil’s specific climate zones, a detail that could delay their launch by nine months and require a costly new data generation process.
Key Takeaways:
* How does RDC 830/2023 officially change the risk classification for your IVD device?
* What are the three new documentation requirements inherited from RDC 751 that most IVD manufacturers are missing?
* Why might your existing EU or FDA clinical data be insufficient for ANVISA now?
* What is the single most common reason for submission delays under this new regulation?
* How can your choice of a Brazilian Registration Holder (BRH) make or break your new application?
* Are your current labels and instructions for use compliant with the new, stricter requirements?
* What post-market surveillance activities are now mandatory for your IVD device in Brazil?
Don't let regulatory surprises derail your expansion into Latin America. Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline global market access for MedTech and IVD companies. We act as your local representative, manage technical dossiers, and provide continuous regulatory monitoring to keep you ahead of changes like RDC 830. To secure your market presence in Brazil, contact us at info@pureglobal.com or visit https://pureglobal.com/.
We uncover the hidden complexities within this harmonization effort, from reclassifying your product's risk level to meeting demands for more robust clinical evidence and local performance data. This shift signals ANVISA's move towards a more demanding and localized regulatory system, making prior foreign approvals less of a guarantee for market access.
A specific case involves a European diagnostics firm whose Class C diabetes monitoring IVD, previously accepted with its existing technical file, now faces rejection. The reason is a buried requirement in the new framework demanding stability studies validated against Brazil’s specific climate zones, a detail that could delay their launch by nine months and require a costly new data generation process.
Key Takeaways:
* How does RDC 830/2023 officially change the risk classification for your IVD device?
* What are the three new documentation requirements inherited from RDC 751 that most IVD manufacturers are missing?
* Why might your existing EU or FDA clinical data be insufficient for ANVISA now?
* What is the single most common reason for submission delays under this new regulation?
* How can your choice of a Brazilian Registration Holder (BRH) make or break your new application?
* Are your current labels and instructions for use compliant with the new, stricter requirements?
* What post-market surveillance activities are now mandatory for your IVD device in Brazil?
Don't let regulatory surprises derail your expansion into Latin America. Pure Global offers end-to-end regulatory consulting, combining local expertise with advanced AI tools to streamline global market access for MedTech and IVD companies. We act as your local representative, manage technical dossiers, and provide continuous regulatory monitoring to keep you ahead of changes like RDC 830. To secure your market presence in Brazil, contact us at info@pureglobal.com or visit https://pureglobal.com/.