Brazil Medical Device Regulations


All documents listed below were published by ANVISA in Portuguese. We have created an English version through an online translation tool and therefore cannot verify the accuracy of the translation. Use the English version for general informational purposes only. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Brazil, you may be interested in our custom regulatory strategy reports for Brazil.

Major Regulations

Syndicate content