Janaina dos Santos de Miranda
Janaina dos Santos de Miranda is a chemical engineer with more than eight years of experience in medical device regulatory affairs.
About Janaina dos Santos de Miranda
She specializes in medical device and cosmetics registration of all risk classes with ANVISA in Brazil, as well as Brazil GMP certification and Brazilian certifications (INMETRO, ANATEL). In her role at Pure Global, she works on Brazil (ANVISA) medical device registration projects. She is a certified lead and internal auditor in ISO standards, including ISO 9001: 2015, ISO 19011: 2018, ISO 13485: 2016 and RDC 665/2022.Prior to joining Pure Global, de Miranda held regulatory consulting positions at renowned companies in Brazil. She holds a bachelor’s degree in chemical engineering from Universidade Estadual de Maringá in Brazil.
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.
Brazil stands as Latin America's largest medical device market, regulated by ANVISA with recent updates to accommodate new technologies and international harmonization.