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

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

€69.00

SKU MDSAP-VIG-BR Category Tags , , , , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

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 death, 30 days for serious deterioration / malfunction), trend signals per RDC 551/2021, foreign event tracking, and CAPA integration.
  • F-VIG-BR.1 Brazilian Reportability Decision Worksheet (Word) — structured assessment of all 4 mandatory questions with evidence fields, causality classification (DEFINITE/PROBABLE/POSSIBLE/UNLIKELY/NOT RELATED/UNDETERMINED), timeline calculator, peer review block, and CAPA linkage.

Why this package: Vigilance reportability decisions are the most-audited area in MDSAP. A documented, peer-reviewed worksheet for every event is the strongest defense in audit and inspection. This package provides exactly that, calibrated to Brazilian regulation.

Format: Microsoft Word
Updated: May 2026
Delivery: Instant download after purchase

€69.00

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.