医療機器規制ハウツーガイド
Pure Globalの規制インテリジェンスによる専門家のガイダンス
利用可能なガイド
Brazil (ANVISA)
Essential guides for navigating Brazil's medical device regulatory landscape
近日公開： 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
近日公開： 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
近日公開： 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
近日公開： Choose a Notified Body • Prepare Technical Documentation for EU MDR
近日公開
USA (FDA)
• Choose a US Agent
• Prepare 510(k) Submission
• Navigate De Novo Classification
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