Foreign medical device manufacturers cannot hold an ANVISA marketing authorisation directly. You need a legally established Brazilian partner to act as the registration holder. MEDAGENT do Brasil combines local representation with practical support for documentation, submission and ongoing compliance.
What is a Brazilian Registration Holder?
The Brazilian Registration Holder is the local company legally responsible for the products registered, imported and distributed in Brazil. It represents the foreign manufacturer before ANVISA, holds the authorisation and manages essential regulatory activities throughout the registration lifecycle.
The route depends on the device type and risk classification. Lower-risk and higher-risk devices follow different regularisation pathways, and some products may also require additional evidence or certification.
