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

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

€69.00

SKU MDSAP-REG-BR Categories , , Tags , , , , , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

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 (hosting service vs distributor), 22 classification rules per RDC 751/2022 Annex I, pathway decision tree, B-GMP certification with MDSAP leverage option, IMDRF-format technical dossier, INMETRO/ANATEL conformity, labeling in Portuguese, UDI/SIUD obligations, lifecycle management.
  • F-REG-BR.1 Brazilian Classification + Pathway Decision (Word) — structured worksheet guiding the user through scope confirmation, application of all 22 RDC 751/2022 classification rules, pathway decision tree, dependencies (INMETRO/ANATEL/B-GMP/SIUD), and sign-off by RA Manager + BRH Technical Responsible.

Why this package: Brazil is one of the most complex MDSAP jurisdictions due to multiple agencies (ANVISA + INMETRO + ANATEL) and the recent UDI/SIUD obligation. This package gives you a clear pathway selection process and a rationale that survives ANVISA review.

Format: Microsoft Word
Updated: May 2026 — reflects RDC 591/2021 (UDI in force July 2025) and current ANVISA regulatory agenda
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.