Preclinical Translation Requirements Across 9 LATAM Regulators: What Each Authority Actually Asks For

A sponsor preparing a first-in-human submission in Latin America typically has one set of preclinical documents: biocompatibility reports, bench testing summaries, animal study reports, sterilization validation, and shelf-life data. All in English.

Then they file in multiple countries and discover that each regulator wants something different from that same package.

Not different science. Different translation treatment. Different document types require different translation types. Different regulators accept different levels of summarization. Some want the full preclinical report translated. Others accept a translated executive summary with the English original appended.

This is where most multi-country submissions lose time. The sponsor translates everything the same way for every country, and two or three regulators send it back because the translation format does not match their specific requirements.

ANVISA requires sworn translations (tradução juramentada) for virtually all preclinical documents submitted as part of a clinical trial or device registration dossier. A certified translation will not be accepted. The sworn translator must be registered with the local Junta Comercial.

For biocompatibility reports referencing ISO 10993, ANVISA expects the translated document to preserve the original test methodology descriptions in full. Summarized translations of preclinical testing are generally not accepted.

ANVISA also requires that any referenced standards be cited using the corresponding ABNT (Brazilian standards body) designation where an equivalent exists.

COFEPRIS accepts certified translations for most preclinical documents. Sworn translations are generally required only for legal certificates and certificates of free sale.

However, COFEPRIS has specific terminology expectations for device descriptions and intended use statements. A preclinical report that describes the device differently from how it appears in the technical summary will generate a prevención (request for information).

For preclinical summaries, COFEPRIS accepts a translated summary with the original English report as an appendix, provided the summary covers all endpoints referenced in the technical dossier.

INVIMA accepts certified translations for preclinical documents. Sworn translations are not routinely required for technical reports, though they may be requested for legal documents.

INVIMA's primary focus in preclinical review is consistency across the dossier. If the preclinical summary uses a term for the device that differs from the term used in the registration application or the IFU, INVIMA will issue a requerimiento.

For first-in-human clinical trial applications, INVIMA expects the full Investigator's Brochure preclinical section to be translated, not summarized.

ANMAT requires certified translations by a traductor público nacional (nationally certified public translator) for preclinical documents. The certification must include the translator's registration number and the corresponding professional council.

ANMAT is particularly attentive to translated units of measurement. Preclinical reports that convert units must show both the original and converted values. A report that presents only converted values without the originals may be flagged.

For multi-study preclinical packages, ANMAT expects each study to be translated as a standalone document with its own certification, not bundled into a single translated file.

DIGEMID accepts certified translations for preclinical documents. The translation must include the translator's professional credentials and a declaration of accuracy.

DIGEMID focuses on the traceability between the preclinical testing and the device specifications. If the preclinical report references a device model number or specification that does not exactly match the registration application, DIGEMID will flag the discrepancy.

For combination products or drug-device combinations, DIGEMID may require additional preclinical documentation beyond what other LATAM regulators request, and each additional document needs its own certified translation.

ISP accepts certified translations and is generally less prescriptive about translation format than ANVISA or ANMAT. However, ISP expects all preclinical documents to be translated in their entirety. Summarized translations are not accepted for the initial submission.

ISP pays close attention to the translation of risk analysis documents (ISO 14971 references). The risk terminology must be consistent with ISP's published guidance on risk classification.

ARCSA accepts certified translations for preclinical documents. The agency has adopted a simplified registration pathway for devices with prior approvals from reference agencies (FDA, CE marking), but the preclinical documentation still needs to be translated into Spanish.

For ARCSA, the key translation requirement is that the device classification justification aligns with Ecuador's national classification rules, which do not always map directly to FDA or EU classifications. The translator needs to know ARCSA's classification terminology.

DNM (Dirección Nacional de Vigilancia Sanitaria, formerly DINAVISA) accepts certified translations. Paraguay's requirements are relatively straightforward compared to larger markets, but the preclinical documentation must still be complete and translated.

DNM increasingly references Mercosur harmonized requirements, so preclinical translations for Paraguay should use Mercosur-aligned terminology where applicable.

SRS accepts certified translations for preclinical documents. The agency's review timeline is generally shorter than larger markets, but translation errors can still trigger delays.

SRS is particularly focused on the translation of labeling and IFU content that relates to preclinical safety data. If the labeling references preclinical testing results, the translated values must match exactly between the preclinical report and the label.

The same preclinical package, filed in nine countries, requires nine different translation approaches. Not nine translations of the same type, but nine country-specific treatments that account for each regulator's format requirements, terminology expectations, document-type routing (sworn versus certified), and cross-referencing standards.

Planning this mapping before the translation starts is the difference between a clean multi-country submission and a staggered series of RFIs that push your timeline back by months.

At Amavita Sciences™, we build this regulatory routing map for every multi-country project before a single word is translated. Every preclinical document gets the right translation type, the right terminology, and the right format for each specific regulator.

That is what First-Pass Acceptance means in practice.