Brazil’s Medical Device Regulatory Landscape in 2026

Get expert insights from Emergo by UL on the rapidly evolving ANVISA landscape and its implications for your medical device regulatory strategy in the largest medical market in LATAM.

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

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.

Webinar date

April 2, 2026

Speakers

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

What you’ll learn

ANVISA regulatory changes

Upcoming regulatory changes for 2025–2026 and what ANVISA’s 2026–2027 priorities mean for your compliance planning.

UDI implementation updates

UDI implementation updates, including the newest requirements and specifics of the SIUD database Normative Instruction.

Actionable insights

Actionable insights from Emergo’s local experience with notifications, registrations, and IVD submissions.

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.

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