In Depth: Brazil medical device approval and compliance


Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK. Registering a device there can be a complex process, due mainly to the constantly evolving regulations.

In this six-part slidecast we will cover the complexities of the Brazilian device approval process, breaking it down into steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of January 2015.

Here is what we will cover:

  1. An overview of the Brazilian regulatory framework [runtime = 3:10]
  2. The steps involved in classifying your medical device [runtime = 3:28]
  3. Brazil Registration Holder [runtime = 1:49]
  4. Quality management System requirements [runtime = 2:53]
  5. Technical file preparation [runtime = 3:06]
  6. Registration [runtime = 3:20]