Brazil's MDR Surprise: ANVISA's Hidden Clause for MedTech Imports | Pure Global

This week, we dissect the immediate fallout from ANVISA's surprise regulatory shift in Brazil. While the move towards EU MDR alignment was expected, a hidden clause mandating local usability studies for high-risk devices has caught many international MedTech firms by surprise, threatening to delay launches and inflate budgets. We explore the specifics of the new RDC 987/2025 resolution and what it means for companies who previously relied on their CE marking for a smoother entry into Latin America's largest market. This episode is a must-listen for regulatory affairs professionals, product managers, and executives focused on global expansion. A leading German cardiac stent company had its Brazilian launch plan finalized, with its budget approved and timeline set. Last week’s ANVISA announcement instantly invalidated their strategy. Now, they're facing an unexpected nine-month delay and an unbudgeted six-figure cost for a mandatory local study they never saw coming. Key questions from this episode: - Does ANVISA's new rule make your existing technical file obsolete for Brazil? - What are the hidden costs and timeline impacts of the mandatory in-country usability studies? - How can you leverage your existing data to potentially streamline this new local requirement? - Could this regulatory shift in Brazil signal a trend for other LATAM markets? - Is your local representative in Brazil equipped to manage these new complex clinical requirements? - What steps should you take today to de-risk your 2026 LATAM launch plans? Navigating sudden regulatory changes requires deep local expertise and a proactive strategy. At Pure Global, we offer end-to-end regulatory consulting, acting as your local representative in over 30 markets, including Brazil. We use advanced AI and data tools combined with on-the-ground expertise to streamline global market access and ensure you're always ahead of the curve. Don't let regulatory surprises derail your growth. Contact us at [e-mail] or visit https://pureglobal.com/ to secure your market presence.