ANVISA Gap Analysis — Brazil
€149.00A scored Excel workbook that measures your device file against every ANVISA requirement and tells you, in one verdict, whether it is ready to file.
Showing all 6 results
-
-
ANVISA Notivisa Vigilance SOP + Reportability Worksheet — RDC 67/2009 (Brazil)
€69.00Process 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…
-
ANVISA Registration SOP + Classification Template — RDC 751/2022 (Brazil)
€69.00Process 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…
-
Brazil Essential Requirements Checklist
€89.00The full set of ANVISA essential requirements (RDC 848/2024), each cross-referenced to the matching EU MDR GSPR so you can reuse your CE evidence.
-
Brazil Technical Dossier Pack
€249.00A set of fill-in Word templates that build an ANVISA technical dossier on the IMDRF table of contents, plus a master index to keep it all straight.
-
Sale!
Full Brazil Market Access Kit
Original price was: €487.00.€399.00Current price is: €399.00.Everything you need to prepare an ANVISA submission — the gap analysis, the essential requirements checklist and the technical dossier pack — in one download, at a saving.
