A Game-Changing Clarification for MedTech Sponsors On December 9, 2025, ANVISA's General Office of Technology Products for Health (GGTPS) issued a formal clarification (Protocol No. 2025289179) conf...
A Game-Changing Clarification for MedTech Sponsors On December 9, 2025, ANVISA's General Office of Technology Products for Health (GGTPS) issued a formal written clarification (Protocol No. 2025289179) confirming that strictly academic, non-commercialization clinical studies with medical devices can proceed in Brazil without prior ANVISA regulatory review — requiring only Ethics Committee (CEP/CONEP) approval. This ruling, signed by ANVISA officer Rafaela de Lima Avelino of the GGTPS division, operationalizes a pathway that many sponsors suspected existed under Brazil's new regulatory framework but had never been formally confirmed by ANVISA itself. It represents a definitive, primary-source confirmation that changes the calculus for early-stage medical device clinical research in Latin America. The Regulatory Framework: From Law 14.874/24 to RDC 837/2023 Brazil's regulatory framework for medical device clinical investigations was fundamentally restructured by two landmark pieces of l…