Course Description

Registration Process for Medical Devices in Brazil

Course Description:

This course covers the basic aspects of medical device registration in Brazil, the proper measures needed for the registration process, and related regulations from ANVISA (Agencia National de Vigilancia Sanitaria) and other regulatory bodies.

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Understand how to register medical devices in the Brazilian market

Who Should Enroll:

Regulatory and quality assurance professionals dealing with international product registrations and compliance are welcomed and encouraged to take this course.

Prerequisite Knowledge/Requirements:

An understanding of the basic regulatory principles as outlined in IMDRF (formerly GHTF) is required, these can be found in the following courses:

  • Pre-market Regulatory Model (ID N170).
  • Post market regulatory model (ID N171)
  • Supporting documents (ID N172)
  • International Implementation (ID N173)
  • Essential principles of safety and performance of medical devices (ID N182)
  • STED and its contents (ID N187)

In addition a detailed understanding of the US Quality systems requirements and Risk management (ISO 14971) are required to successfully achieve the above stated objectives. You can learn about these topics in the following WMDO courses:

  • Overview of US FDA Quality System Regulation (ID 118)
  • ISO 14971:2007 Review (ID 78)
  • Preparing Risk Management File and Which Techniques Apply (ID 83)
  • Integrating Risk Management Into Your Quality Management System (ID 94)
  • Implications of EN-ISO 14971:2012 (N189)quality systems requirements as outlined in ID 118: “Overview of US FDA Quality System Regulations.”

Subject Matter Expert:
Marcelo Antunes

53 min

Release date:

Related resources:

Case studies:

Basic Account: € 156.00
Premium Account: € 117.00

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