『Navigating Brazil's 2025 UDI Mandate: A Pure Global Guide to ANVISA's SIUD for MedTech Success in LATAM』のカバーアート

Navigating Brazil's 2025 UDI Mandate: A Pure Global Guide to ANVISA's SIUD for MedTech Success in LATAM

Navigating Brazil's 2025 UDI Mandate: A Pure Global Guide to ANVISA's SIUD for MedTech Success in LATAM

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 Brazil, Latin America's largest MedTech market, is implementing a mandatory Unique Device Identification (UDI) system, with a critical deadline for high-risk devices looming in mid-2025. This change, mandated by ANVISA's RDC 591/2021, requires immediate action from manufacturers to ensure their products remain on the market. This episode of LATAM MedTech Insights breaks down the essential steps for preparing for Brazil's UDI rollout. We explore the unique challenge where device labeling is required before the official government database (SIUD) is fully active, creating significant operational hurdles. We'll provide a clear roadmap for what your company needs to do right now to avoid costly disruptions to your Brazilian operations. **Case Study Highlight:** Imagine your company manufactures a Class IV cardiovascular stent. You have all the clinical approvals, but your product is suddenly blocked from entering Brazil on July 11, 2025. The reason is a non-compliant label. Your team waited for final guidance on the UDI database, but the fixed labeling deadline passed, halting your sales and forcing an expensive, rushed relabeling project. This scenario is avoidable, and this episode explains how. **What You'll Learn (本期干货):** * What is the crucial compliance date in 2025 that affects all Class IV medical devices in Brazil? * Why do you need to change your product labels now, even if the SIUD database isn't live? * How do ANVISA's UDI data requirements differ from those of the US FDA or European MDR? * What are the first three steps every manufacturer should take to begin their UDI implementation project? * What is the essential role of a Brazil Registration Holder (BRH) in this new process? * How can you manage the artwork and logistical challenges of a full labeling redesign? * What are the most common pitfalls companies face when preparing for a new UDI system? At Pure Global, we offer end-to-end regulatory consulting to help MedTech and IVD companies navigate complex market access challenges like Brazil's UDI implementation. We combine local expertise with advanced AI tools to streamline your path to compliance. For support with regulatory strategy, technical dossier submission, or local representation in Brazil, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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