No local subsidiary needed
You enter the Brazilian market without opening a company, without your own AFE license and without a local regulatory structure.
New line of business
Registration Holder in Brazil for foreign companies
Brazilian law requires the registration holder of a product to be a company based and authorized in Brazil. CGA takes on that ownership on your behalf, allowing your product to be registered, imported and marketed in full compliance.
Why have CGA as your Holder
Technical responsibility assured
Qualified professionals are technically accountable for the product before ANVISA and the sanitary surveillance authorities.
Reduced time-to-market
We leverage your existing CE Mark and FDA documentation, shortening the path to registration.
Distributor independence
Your registration is not tied to your importer, preserving your commercial freedom in Brazil.
How it works
The process, step by step
A documented flow, from the first assessment to the continuous maintenance of your registration in Brazil.
- 01
Assessment and classification
Portfolio analysis, product risk classification and definition of the applicable regulatory pathway in Brazil.
- 02
Registration holding agreement
Formalization of CGA as registration holder, with a representation letter issued by the foreign manufacturer.
- 03
Technical dossier and submission
Translation and adaptation of source documentation (CE/FDA), dossier assembly and filing with ANVISA.
- 04
Publication and market release
Registration/notification granted, Portuguese labeling and release for import and commercialization.
- 05
Post-registration maintenance
Amendments, renewals, post-market surveillance, responses to requirements and support to sanitary authorities.
Our clients
