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Pure Global의 규제 인텔리전스로 구동되는 전문가 지침
사용 가능한 가이드
Brazil (ANVISA)
Essential guides for navigating Brazil's medical device regulatory landscape
곧 출시 예정: 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
곧 출시 예정: 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
곧 출시 예정: 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
곧 출시 예정: Choose a Notified Body • Prepare Technical Documentation for EU MDR
곧 출시 예정
USA (FDA)
• Choose a US Agent
• Prepare 510(k) Submission
• Navigate De Novo Classification
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