Borderline & Combination Products
Borderline & Combination Products — ANVISA medical device regulation in Brazil.
Classification Rules — ANVISA Catalogue
Classification Rules — ANVISA Catalogue — ANVISA medical device regulation in Brazil.
How Classification Works
How ANVISA classifies medical devices into Classes I–IV using a risk-based framework under RDC 751/2022.
IVD Classification (RDC 36/2015)
IVD Classification (RDC 36/2015) — ANVISA medical device regulation in Brazil.
MERCOSUL Classification Alignment
MERCOSUL Classification Alignment — ANVISA medical device regulation in Brazil.
SaMD Classification in Brazil
SaMD Classification in Brazil — ANVISA medical device regulation in Brazil.
Class I · II · III · IV — Overview
Detailed overview of each ANVISA medical device class, their characteristics, regulatory pathways, and examples.