Pure Global: Brazil's SaMD Shake-Up - Navigating ANVISA's Unseen AI Hurdles

Artikel konnten nicht hinzugefügt werden

Leider können wir den Artikel nicht hinzufügen, da Ihr Warenkorb bereits seine Kapazität erreicht hat.

Der Titel konnte nicht zum Warenkorb hinzugefügt werden.

Bitte versuchen Sie es später noch einmal

Der Titel konnte nicht zum Merkzettel hinzugefügt werden.

Bitte versuchen Sie es später noch einmal

„Von Wunschzettel entfernen“ fehlgeschlagen.

Bitte versuchen Sie es später noch einmal

„Podcast folgen“ fehlgeschlagen

„Podcast nicht mehr folgen“ fehlgeschlagen

Pure Global: Brazil's SaMD Shake-Up - Navigating ANVISA's Unseen AI Hurdles

Jetzt kostenlos hören, ohne Abo

Details anzeigen

Über diesen Titel

This week on LATAM MedTech Insights, we analyze the seismic new draft regulation from Brazil's ANVISA that is set to overhaul the rules for Software as a Medical Device (SaMD). This proposal introduces stringent new requirements for AI technologies and local data management, promising to reshape market access for all foreign MedTech companies targeting Brazil. We dive into the real-world impact by examining the case of a European AI diagnostics firm. Their expansion strategy, once clear, is now facing critical roadblocks due to unexpected demands for in-country clinical studies and data hosting, threatening significant delays and cost overruns. This story is a crucial lesson for any innovator looking to enter Latin America's most complex market. Key Takeaways: - Why is ANVISA suddenly proposing a major revision to its two-year-old SaMD regulation? - What are the specific new cybersecurity and data hosting rules for AI medical devices? - Will your existing FDA clearance or CE Mark still be enough for your software registration in Brazil? - What defines a "representative Brazilian population" for the new mandatory clinical validation studies? - How can you submit feedback on this draft regulation before it becomes law? - What strategies can turn these new regulatory barriers into a competitive advantage? - How should this change affect your company's five-year expansion plan for Latin America? Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, using local expertise and advanced AI tools to streamline global market access. Whether you are navigating new draft regulations or planning a multi-market launch, we build efficient pathways for your products. Confused about the new ANVISA rules? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a strategic consultation.

Noch keine Rezensionen vorhanden