Guide catalog · twelve countries
LATAM Regulatory Translation Guides — Twelve Countries
Amavita Sciences™ publishes a primary-source-grounded guide for every LATAM regulator we serve. Each guide walks through the statute, the resolutions in force, the sworn-translator regime, and the operational risk zones — cited to primary sources, dated, and refreshed as the regulatory landscape moves. Twelve guides below. One row for every regulator in our matrix.
12 of 12 guides
COFEPRIS
México
México's translation regime runs through the perito traductor sworn tier. Full framework across LGS-derived reglamentos, the CTD language-of-filing rules under Reglamento de Insumos para la Salud, and the device reglamento in force.
Jump to preclinical sections
- D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only, or does it require DTP?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.5.0 changelog
ANVISA
Brasil
Brasil is the largest LATAM market and the only Portuguese-target one. ANVISA requires tradução juramentada under Decreto 13.609/1943 for every foreign-issued official document, and the CTD language rules under RDC 200 and RDC 753 shape the entire submission surface.
Jump to preclinical sections
- D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only, or does it require DTP?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v2.0.0 changelog
INVIMA
Colombia
Colombia runs a certified-translator regime under Ley 962 of 2005 and Resolución 1959 of 2020. INVIMA's Sala Especializada de Medicamentos and Sala Especializada de Dispositivos Médicos each carry distinct language expectations for the CTD stack.
Jump to preclinical sections
- D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only, or does it require DTP?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.3.0 changelog
ANMAT
Argentina
Argentina's traductor público matriculado regime under Ley 20305 governs every legal document. ANMAT's Disposición 5330/1997 for drugs and Disposición 2318/2002 for devices define the language surface, with recent 2024–2026 amendments reshaping the CTD narrative.
Jump to preclinical sections
- D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only, or does it require DTP?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.3.0 changelog
ISP
Chile
Chile's ISP registration regime lives inside Decreto 3/2010 for pharmaceuticals and Norma Técnica for devices. Translation practice concentrates on the Investigator's Brochure and product information leaflets — with recent 2025 amendments narrowing the English-permitted surface.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only, or does it require DTP?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.3.0 changelog
DIGEMID
Perú
Perú's DIGEMID market-authorization pathway allows CTD Modules 3, 4, and 5 in English under Comunicado 008-2022. But SUDEC confirmed in writing on 24 August 2026 that the CTA process before INS is governed by DS 021-2017-SA Art. 67 — full Spanish for protocol and IB.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only, or does it require DTP?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.4.0 changelog
ARCSA
Ecuador
Ecuador does not require full-text CTD translation for Module 4 — but ARCSA-DE-2025-034-DASP tightened Module 2 to full Spanish in October 2025, and ARCSA-DE-2026-003-DASP inverts the drug rule for devices in January 2027. LOOETA art. 29 governs authenticated translations.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only or does it require desktop publishing (DTP)?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.0.0 changelog
DNFD / MINSA
Panamá
Panamá is the only LATAM jurisdiction with a statute-level English carve-out for study evidence (Ley 419 Art. 33). But the CTA-stage preclinical translation scope is not statutorily defined — Amavita Sciences™ has a formal consulta on record with MINSA REGULAIPS.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only or does it require desktop publishing (DTP)?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.1.0 changelog
SRS
El Salvador
El Salvador's SRS runs on a bilingual Spanish/English acceptance framework for CTD submissions, anchored by the Ley de Medicamentos and its 2012 reglamento. Traducción oficial applies to legal documents; scientific content follows a hybrid regime.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only or does it require desktop publishing (DTP)?
- D.3 If translation is NOT required — what substitutes for it?
- The two regulatory pathways trigger different translation obligations
Last updated · v1.4.0 changelog
CONIS
Costa Rica
Costa Rica's preclinical translation burden is smaller than most sponsors expect — the reliance route makes translating an RRA-approved report a defect under Decreto 39433-S. But Decreto 39061-S art. 44(b)-(c) requires sworn IB and protocol translation as indivisible folio-counted instruments.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation
- D.1 Is full-text translation of the entire preclinical CTD (Module 4) required?
- D.2 Scope of the "DTP" — what preclinical content actually has to be delivered
- D.3 What substitutes for full-text translation — four mechanisms
- D.4 Consolidated preclinical instruction table
Last updated · v1.0.0 changelog
DIGEMAPS
República Dominicana
The Dominican Republic is a decree-level bilingual filing jurisdiction — Decreto 246-06 Art. 39 requires the preclinical dossier in Spanish or with a Spanish translation attached, by name. Plus: CONABIOS Resolución 03-25 bars, from 1 September 2026, any protocol whose ethics review came from a non-certified committee.
Jump to preclinical sections
- Section D. Preclinical Translation Requirements — The Full Answer
- D.1. Does preclinical need to be translated in the DR? YES — at the decree level.
- D.2. The DR bilingual filing architecture — what it looks like in practice.
- D.3. Three narrow substitution mechanisms — and why two don't help you.
- D.4. Consolidated DR preclinical table.
Last updated · v1.1.0 changelog
DINAVISA
Paraguay
Paraguay is the LATAM country where translation depth determines trial approval. DINAVISA INF-DI-01 V01 items 1.7 and 1.8 require the Investigator's Brochure and protocol in complete Spanish AND complete original language; Resolución 056/2026 Art. 2 makes non-compliance an explicit rejection ground.
Jump to preclinical sections
- Section D. Preclinical / non-clinical documentation — the three operational questions
- D.1 Do we have to translate every page of the preclinical stack?
- D.2 If translation IS required — is it text-only or does it require desktop publishing (DTP)?
- D.3 If translation is NOT required — what substitutes for it?
- D.4 Consolidated preclinical instruction table
Last updated · v1.0.0 changelog
Companion guides
Cross-cutting reference pages.
Certification
Apostille vs. Sworn Translation in LATAM
When an apostille is enough, when a sworn or certified translation is required, and how to decide per country.
Classification
Document Classes for LATAM Regulatory Translation
Classify a file as protocol, ICF, IB, labels, legal-admin, or technical reading aid before opening the matching country guide.
All twelve guides are updated on a rolling basis as regulators publish new resoluciones, decrees, and circulars. Amavita Sciences™ tracks the primary-source landscape for every country in the matrix and revises each guide within seven business days of a material change.
To engage Amavita Sciences™ on a scoped pilot for any of the twelve countries, contact Julio G. Martinez-Clark at jmclark@amavitasciences.com.