Brazil’s Medical Device Regulatory Landscape in 2026

Stay ahead of Brazil’s rapidly evolving medical device regulatory landscape

In this focused webinar covering key updates for 2025 and expectations for 2026, our experts will share an overview of the Brazilian medical market, ANVISA’s priorities for 2026–2027, the latest UDI requirements including the newly released Normative Instruction for the SIUD database, and practical insights from Emergo’s experience navigating notifications, registrations, IVD pathways, and reliance mechanisms in Brazil. Ideal for regulatory professionals and medical device manufacturers preparing for continued market success.

Join Milena Borrasca Pereira and Luis Levy, Consulting Managers for Brazil at Emergo by UL, for a comprehensive breakdown of key changes affecting medical device submissions and market access in 2026.

Who should attend?

If Brazil is part of your commercial or regulatory strategy, this session is essential.  

This webinar is ideal for:

About the presenters

Milena Borrasca Pereira, Consultant QA/RA, Brazil, Emergo by UL

Milena Borrasca Pereira ​​has over 8 years of experience in Regulatory Affairs in the area of ​​in vitro diagnostics (IVD), health products and certification of electromedical equipment. She has expertise in people management, governance, leadership and healthcare strategy.

Luis Levy, Director RA/QA, Brazil, Emergo by UL

Luiz Levy has over fifteen years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment and disposables subject to INMETRO Certification. Luiz’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 665/2022, ISO 13485:2016, EU Regulation 2017/745 (MDR), FDA 21 CFR 807, FDA QSR 21 CFR 820, MDSAP-Medical device Single audit program; performing multiple local and foreign (U.S., Europe, Japan, China) audits to prepare companies for ANVISA inspections; assisting companies during ANVISA inspections; compiling medical device and IVD applications; clinical data review; and compiling and peer reviewing market access reports.