Brazil ANVISA Medical Device Regulatory Requirements

At the end of this short course, successful learners will be able to:

• Understand ANVISA’s regulatory framework for medical devices, including device classification and registration routes
• Differentiate between Cadastro (simplified registration for lower-risk devices) and Registro (full registration for higher-risk devices)
• Identify the role of a Brazilian Registration Holder (BRH) and the importance of local representation
• Apply Brazil’s requirements for labelling, instructions for use, and Portuguese language compliance
• Recognize post-market surveillance obligations, including vigilance, reporting and recalls
• Navigate INMETRO and ANATEL certification
• Understand MDSAP’s role and how Brazil interacts with international regulatory frameworks

This course is for individuals or organizations who want to understand Brazil’s ANVISA Medical Device Regulatory Requirements.

Successful completion of the course examination will entitle each Learner to receive a digital Certificate of Completion.

In order to successfully complete this course, each Learner will need to:

• Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.