Medical Device Regulatory How-To Guides
Expert guidance powered by Pure Global's regulatory intelligence
Available Guides
Brazil (ANVISA)
Essential guides for navigating Brazil's medical device regulatory landscape
Coming Soon: Prepare ANVISA Technical Documentation โข Navigate the ANVISA Registration Process โข Understand Brazilian GMP Requirements
Mexico (COFEPRIS)
Expert guidance for COFEPRIS medical device registration and market entry
Coming Soon: Leverage the COFEPRIS Abbreviated Pathway โข Prepare COFEPRIS Technical Documentation โข Navigate Mexican GMP Requirements (NOM-241)
Colombia (INVIMA)
Actionable guidance for INVIMA registration, importer coordination, and compliance in Colombia
Coming Soon: Prepare INVIMA Technical Dossiers โข Coordinate CCAA Importers for Colombia โข Master Colombia Vigilance & UDI Reporting
Europe (EU MDR)
Comprehensive guides for EU MDR compliance and CE marking
Coming Soon: Choose a Notified Body โข Prepare Technical Documentation for EU MDR
Coming Soon
USA (FDA)
โข Choose a US Agent
โข Prepare 510(k) Submission
โข Navigate De Novo Classification
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