Brazil Medical Device Regulations – A Comprehensive Overview

This two-hour course provides a comprehensive overview of the regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way Brazil is utilizing MDSAP.

By the end of this course, you will be able to:

• Identify the legal and regulatory framework for medical devices in Brazil
• Determine the correct classification for medical devices
• Understand how Brazil utilizes MDSAP
• Understand the pre-market pathway(s) and requirements for medical devices in Brazil
• Understand the quality management system regulations required to market a medical device or IVD in Brazil
• Understand the post-market requirements for medical devices in Brazil

This course is essential for anyone wanting to bring a medical device or IVD to market into Brazil, and also for employees in R&D, regulatory, quality and compliance functions.

By completing/passing this course, you will attain the Medical Device Certificate.