anvisa

  • ANVISA Notivisa Vigilance SOP + Reportability Worksheet — RDC 67/2009 (Brazil)

    ANVISA Notivisa Vigilance SOP + Reportability Worksheet — RDC 67/2009 (Brazil)

    €69.00

    Process Package — Vigilance Reporting Brazil (Notivisa) Complete framework for Brazilian medical device vigilance. Covers RDC 67/2009 reportability assessment, Notivisa submission, causality classification, foreign event tracking, and field actions. What’s included: SOP-VIG-BR Vigilance Reporting Brazil — full procedure with the 4-question reportability framework per RDC 67/2009, Notivisa submission process, causality classification, timelines (10 days for…

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  • ANVISA Registration SOP + Classification Template — RDC 751/2022 (Brazil)

    ANVISA Registration SOP + Classification Template — RDC 751/2022 (Brazil)

    €69.00

    Process Package — Marketing Authorization Brazil (ANVISA) Complete framework for ANVISA medical device authorization. Covers BRH designation, classification under RDC 751/2022, Notificação vs Registro pathway selection, B-GMP certification (with MDSAP leverage), INMETRO and ANATEL conformity, and UDI/SIUD compliance (in force since July 2025). What’s included: SOP-REG-BR Marketing Authorization Brazil — full procedure: BRH designation criteria…

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