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Medical Device Registration Process in Brazil

Steps to gaining market authorization from ANVISA

Interested in selling your medical device in Brazil? Brazil's device registration process is well established, but rather complex. It's important to understand the process upfront, so you can plan your market entry accordingly and avoid future delays.

This white paper, authored by Luiz Levy at EMERGO by UL, will answer your biggest questions about ANVISA medical device registration.

 

You will learn:

  • An overview of important medical device regulations in Brazil
  • How ANVISA classifies and groups medical devices
  • Requirements for registro vs. cadastro registration routes
  • Quality system requirements and audit procedures (Brazil GMP)
  • How to avoid BGMP audit delays
  • An overview of recent ANVISA regulatory updates
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Medical device registration process in Brazil

 
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ABOUT EMERGO by UL
 

Emergo by UL is the official in-country regulatory representative for more than 2,000 medical device and IVD companies worldwide. With an office in Brazil, we can act as your independent BRH and remove any possibility that you will be stuck with an underperforming distributor for the duration of your registrations. Our experienced consultants in Brazil will also guide you through each step of Brazil's registration process. Visit our website to learn more.

 

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ABOUT GREENLIGHT GURU
 
Greenlight Guru is a modern quality management software platform used by medical device companies in over 25 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry-specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Click here to learn more.