The 2021 Practical Regulatory Affairs for ANVISA Medical Devices.

Brazil has the largest medical device market in South America, with a unique regulatory framework and a huge marketing potential for foreign investors. As USAhas FDA as regulatory agency, in Brazil our products are regulated by ANVISA. This course focuses on the main topics related to medical devices and life sciences products, giving you an overview of the ANVISA structure, using products examples to help you understand not only the regulations themselves, but how to effectively comply with them. Also, this course can be relevant for manufacturers owners who intend to expand its business.

What you’ll learn on this course:

Learn about BR regulations for medical devices, and the role of the ANVISA

Understand the various regulatory pathways available for medical devices in Brazil

How to classify medical devices as per Brazilian regulations

Get to know what are the main criterias to initiate a project of a new product submission in Brazil

How ANVISAis structure, and its organogram

Understand the device grouping

Understand the medical devices definitions

The main essential requirements for register of medical device products in Brazil.

Criterias to be filled before submitting a registration of a new product at ANVISA.

Written and developed by a experienced Brazilian pharmacist currently working in industry, this course focuses on the most common topics and questions received from professionals who wants to understand how this business works in Brazil.