Guías Prácticas de Regulación de Dispositivos Médicos
Orientación experta impulsada por la inteligencia regulatoria de Pure Global
Guías Disponibles
Brazil (ANVISA)
Essential guides for navigating Brazil's medical device regulatory landscape
Próximamente: Prepare ANVISA Technical Documentation • Navigate the ANVISA Registration Process • Understand Brazilian GMP Requirements
Mexico (COFEPRIS)
Expert guidance for COFEPRIS medical device registration and market entry
Próximamente: Leverage the COFEPRIS Abbreviated Pathway • Prepare COFEPRIS Technical Documentation • Navigate Mexican GMP Requirements (NOM-241)
Colombia (INVIMA)
Actionable guidance for INVIMA registration, importer coordination, and compliance in Colombia
Próximamente: Prepare INVIMA Technical Dossiers • Coordinate CCAA Importers for Colombia • Master Colombia Vigilance & UDI Reporting
Europe (EU MDR)
Comprehensive guides for EU MDR compliance and CE marking
Próximamente: Choose a Notified Body • Prepare Technical Documentation for EU MDR
Próximamente
USA (FDA)
• Choose a US Agent
• Prepare 510(k) Submission
• Navigate De Novo Classification
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