Brazil Regulatory Updates

As an evolving regulatory agency, the National Health Surveillance Agency, ANVISA, is continually introducing updates and innovations to Brazil’s medical device regulations. Staying informed is critical to maintaining compliance and successful market access.

Our experts will walk through key changes shaping Brazil’s regulatory landscape. In this session, our presenters will cover:

• Recent updates from ANVISA’s 2024-2025 regulatory agenda, including the status of current and upcoming regulations under development and their expected impact on the market.
• Unique Device Identification (UDI) requirements, including marking rules, the ANVISA UDI system and the compliance deadline in Brazil.
• Our team will outline the responsibilities for entities that must submit UDI information and should be in place by July 2025 for medical devices.

About the presenters

Luiz Levy, RAC, manager, Quality and Regulatory Affairs

Luiz Levy is located in São Paulo, Brazil, and has over ten years of medical device industry experience, primarily focused on high-risk devices, including implantable devices, electrical medical equipment and disposables subject to INMETRO Certification. Levy’s background includes: implementing and auditing quality systems to B-GMP Regulation RDC 665/2022, ISO 13485:2016, Directive 93/42/EEC, 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) 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.

As manager of Quality and Regulatory Affairs, Levy has peer-reviewed more than 300 regulatory filings and reports, conducted multiple on-site audits on local and foreign manufacturers, performed internal audits, and performed or reviewed more than 400 classifications/technical files of healthcare products. He also contributed to the final draft of new ANVISA (RDC) regulations during a series of strategic meetings with the agency. Levy is the designated health manager for Emergo’s Brazil Registration Holder services, and he additionally manages Emergo Brazil’s RDC 665/2022 quality system. Prior to Emergo by UL, he held RA/QA positions at CPL Medicals, Goen3 and Medics.

Lilian Pinheiro, lead quality and regulatory affairs consultant

Lilian Pinheiro is located in Brazil and has over 10 years of industry experience, primarily focused on high-risk IVD devices, including immunohematology and blood virus. Her background includes extensive experience in ANVISA activities, such as Registro applications, prior analysis (INCQS), regulatory research and pathway, import/export process, company licenses, for controlled substances (Brazilian Army and Federal Police) and environmental licenses.