Janaina dos Santos de Miranda
Janaina dos Santos de Miranda writes on Brazil medical device regulation, ANVISA requirements, and Latin America market access for Pure Global.
About Janaina dos Santos de Miranda
Janaina dos Santos de Miranda writes on Brazil medical device regulation, ANVISA requirements, and Latin America market access for Pure Global.
Latest Articles
Brazil's health regulator is moving fast, strengthening international alliances and overhauling key rules for medical devices, software, and post-market surveillance. Learn how ANVISA's 2026–2027 priorities will affect your registration strategy.
Medical device manufacturers sometimes shy away from Brazil as a potential market due to its cumbersome and meticulous regulatory requirements. But if you already have CE Marking, ANVISA approval is more accessible than you think. Learn how ANVISA requirements overlap with the EU MDR.
Brazil’s Unique Device Identification (UDI) system is moving toward full enforcement, with mandatory labeling for Class IV devices starting July 10, 2025. This post breaks down the key requirements under RDC 591/2021 and RDC 884/2024, including SIUD database functions, labeling rules, and preparation steps for manufacturers.