If you are thinking about entering the Brazilian market for the first time, understanding ANVISA’s regulatory requirements can be overwhelming. Information about medical device regulations on the ANVISA website can be confusing and does not tell the full story about how the registration process really works, or what is required of you as a manufacturer.
To help medical device manufacturers who want to export medical devices to Brazil, we assembled a packet that includes the basic information you need before deciding to enter the Brazilian market. It outlines the registration requirements and ongoing obligations to maintain compliance.
If you set aside just one hour to read/watch these items, we guarantee you will have a MUCH better understanding of how ANVISA’s regulatory process works.
No salesperson will call you
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. Int
read moreAll documents listed below were published by ANVISA in Portuguese and translated by Emergo into English. Use the English for informational purposes
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