Revised IVD Regulation RDC 830/2023

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 presenters/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 presenters 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.