Brazil · Portuguese · ANVISA + CONEP
ANVISA translation, tuned for Brazilian regulatory review.
A focused entry point into what ANVISA and CONEP expect from Portuguese clinical trial and registration documentation — and how an Amavita pilot delivers it without CONEP parecer rounds.
What this covers
ANVISA in three moving parts.
What ANVISA requires
Protocol, TCLE, IB, DDCM sections, and safety reports in Brazilian Portuguese with MedDRA and CID-10 terminology.
Jump to section →Why general AI fails
Neutral-Portuguese output and literal back-translations of safety language trigger CONEP requests and dossier holds.
Jump to section →How Amavita covers it
MD-led review, Brazilian-Portuguese linguists, and certification coordination — sized to a pilot before you commit a program.
Jump to section →Ready to scope your Brazil pilot?
Start the pilot form and get a timeline in 2 business days.
Frequently asked
ANVISA translation, quick answers.
What does ANVISA require in Portuguese for a clinical trial submission?
ANVISA and CONEP expect the protocol, TCLE (informed consent), investigator's brochure, DDCM sections, and safety reports in Brazilian Portuguese, using MedDRA and CID-10 terminology as adopted locally.
Is a sworn (juramentado) translator required for ANVISA?
Sworn translation is required for legal foreign documents used in registration (e.g., GMP certificates, powers of attorney). Technical documents like protocols and TCLEs require certified medical translation with qualified reviewer sign-off.
How does the Amavita pilot cover ANVISA submissions?
A pilot scopes one protocol or dossier for Brazil, delivers an MD-reviewed Portuguese package (protocol, TCLE, IB summary), and includes a pre-submission QC pass aligned to current ANVISA and CONEP expectations.
How ANVISA compares to the rest of the world.
ANVISA does not set its rules in isolation. Our primary-source review of preclinical translation requirements across nine LATAM regulators places Brazil on the same three-tier map used above, so you can see where ANVISA is stricter — and where it is more permissive — than its neighbours.
Outside the region the picture changes again. The companion study of preclinical translation rules at eight non-LATAM regulators, from FDA and EMA to PMDA, NMPA, MHRA, Health Canada, TGA and Swissmedic found no primary instrument requiring visual replication of a Module 4 study report, which is why the sworn-translation ceiling described on this page is a LATAM-native construct.
If you are budgeting a multi-country programme, read the three-tier framework for ANVISA preclinical translation in the LATAM regulator study before deciding what to translate for Brazil.
Next step
Scope an ANVISA pilot this quarter.
Share your Brazil protocol or registration dossier. Our team will reach out within 2 business days with a scoped pilot proposal and timeline.