Revised IVD Regulation RDC 830/2023

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

Watch now: Revised IVD regulation RDC 830/2023

Our Emergo by UL subject matter expert shares insights on how to navigate revised IVD regulation RDC 830/2023, including practical information intended to equip manufacturers for future medical device marketing submissions.

Webinar date

April 30, 2024

Speaker

Lilian Pinheiro, lead quality and regulatory affairs consultant

The ANVISA – Agência Nacional de Vigilância Sanitária issued Resolution RDC No. 830/2023, on Dec. 11, 2023. The resolution is intended to help IVD medical device manufacturers determine what information is required in a registration submission. The Resolution outlines a new road map that focuses on sanitary classification, notification and registro applications and labeling requirements.

In this webinar, the presenter will help attendees develop a greater understanding of the decision points they might face when determining a submission category and will examine the examples provided by the ANVISA.

The presenter will also discuss the evaluation information the ANVISA suggests providing for each category and will share practical information intended to equip manufacturers for future medical device marketing submissions.

About the presenter

Lilian Pinheiro, lead quality and regulatory affairs consultant

Lilian Pinheiro is located in Brazil and has over 15 years of Medical Device industry experience primarily focused on high-risk IVD devices, including immune-hematology and blood virus diagnostics. Pinheiro’s background includes extensive experience in ANVISA activities, such as Registro applications, prior analysis (INCQS), regulatory research and pathways, import/export processes, and company licenses for controlled substances (Brazilian Army and Federal Police), as well as environmental licenses. She is also specialized in European IVDD and IVDR requirements and has assisted numerous manufacturers with reviews to confirm or achieve compliance with the current regulations.