What is a Medical Device?
The definition of a medical device under Brazilian law (RDC 751/2022 and Lei 6.360/1976), including intended purpose, examples, and scope.
What is an IVD?
Definition of in vitro diagnostic devices (IVDs) under ANVISA's RDC 36/2015, scope, and classification overview.
What is Not a Medical Device?
Products excluded from ANVISA medical device regulation — drugs, cosmetics, food, and general consumer products.
Borderline & Combination Products
How ANVISA handles borderline products at the device/drug/cosmetic interface, and combination products under Brazilian law.
Regulatory Framework Overview
Overview of Brazil's medical device regulatory system — ANVISA, SNVS, the role of state VISA bodies, and the legal foundation.
ANVISA — The National Authority
Overview of ANVISA's structure, mandate, and role as Brazil's medical device regulatory authority.
SNVS — National Health Surveillance System
Overview of Brazil's Sistema Nacional de Vigilância Sanitária (SNVS) and its role in medical device oversight.
State & Municipal VISA Bodies
Role of Brazil's state and municipal health surveillance bodies (VISA) in medical device enforcement and licensing.
Key Roles and Responsibilities
Who needs to comply with ANVISA medical device regulation — manufacturers, importers, distributors, Responsável Técnico, and Responsável Legal.
Lifecycle of a Medical Device in Brazil
The complete regulatory lifecycle of a medical device in Brazil — from classification through registration, post-market and renewal.
MERCOSUL Alignment & GMC Resolutions
How Brazil's medical device regulation aligns with MERCOSUL harmonised resolutions and what this means for manufacturers.
Glossary of Key Terms (EN / PT)
Bilingual glossary of key ANVISA medical device regulatory terms in English and Portuguese.