amavita

The LATAM regulatory matrix · free and public

Every language requirement, with the instrument it comes from.

Which countries demand a sworn translation and which accept a translator's certificate. Which accept English for parts of a dossier. Which require the Spanish variant of that country specifically. Each answer cites the resolution, decree, or circular it comes from — with the date it was issued — so you can check us before you hire us.

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13-page PDF, every rule cited to the resolution, decree, or circular behind it. Use it inside your regulatory affairs meetings, share it with the sponsor, send it to counsel — the primary sources are linked on every page.

REF: LATAM-MTX-2024
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COFEPRIS

Mexico · es-MX

Sworn translation
Only for non-ES/EN documents
English accepted
Yes
Instrument
Reglamento de Insumos para la Salud, Art. 153
Date
2 Jan 2008 (last reform 31 May 2021)

ANVISA

Brazil · pt-BR

Sworn translation
Only when doc not in PT/EN/ES
English accepted
Partial (dossier only, not IFU/labels)
Instrument
RDC nº 751/2022, Art. 10 §§9-10
Date
15 Sep 2022

INVIMA

Colombia · es-CO

Sworn translation
Yes — traducción oficial for non-Spanish
English accepted
Only with official Spanish translation
Instrument
Decreto 4725 de 2005, Art. 49
Date
26 Dec 2005

ANMAT

Argentina · es-AR

Sworn translation
Yes — traductor público matriculado
English accepted
No carve-out for legal documents
Instrument
Disposición 2318/02 (T.O. 2004), Anexo III
Date
23 May 2002 (T.O. 2004)

ISP

Chile · es-CL

Sworn translation
Not codified in decree; case-by-case
English accepted
Not as substitute; ES required for labels/IFUs
Instrument
Decreto Supremo 825/1998 + ISP guidance
Date
30 Nov 1998 (published 21 Aug 1999)

DIGEMID

Peru · es-PE

Sworn translation
No — traducción simple accepted
English accepted
Partial — with Spanish translation
Instrument
Decreto Supremo 016-2011-SA, Art. 137
Date
27 Jul 2011

ARCSA

Ecuador · es-EC

Sworn translation
Only for non-ES/EN legal documents
English accepted
Yes — equal footing with Spanish
Instrument
Resolución ARCSA-DE-2026-003-DASP, Arts. 12-13
Date
28 Apr 2026 (in force 28 Jan 2027)

MINSA

Panama · es-PA

Sworn translation
Yes — traductor público autorizado de Panamá
English accepted
Partial — data sheets and manuals only
Instrument
Decreto Ejecutivo 490/2019
Date
4 Oct 2019

Educational summary of publicly available regulation, not legal advice. Sworn translation is a legally reserved title in Latin America; Amavita Sciences™ does not offer it and does not claim it. Where required, we route to a licensed sworn translator in-country. Requirements move — the per-country sections below carry the article-level detail and the primary source link for each entry.

COFEPRIS — Mexico

Comisión Federal para la Protección contra Riesgos Sanitarios

Instrument
Reglamento de Insumos para la Salud (federal regulation under the Ley General de Salud)
Published
Originally 4 February 1998; language clause (Art. 153) added 2 January 2008; last reform 31 May 2021
Article / clause
Artículo 153; related labeling provisions in Art. 179 referencing NOM-137-SSA1 and NOM-241-SSA1
What the rule says
Documents accompanying applications must be drafted in Spanish or English. Documents issued by foreign authorities must be apostilled or legalized and, if in a language other than Spanish or English, must be accompanied by a translation from a certified perito traductor holding a professional license (cédula profesional).
Our reading
English is fully accepted for the technical dossier — no Spanish translation is required if the source is already in English. Sworn translation applies only when the source is in a third language. Labeling and IFUs must be in Mexican Spanish per the NOM standards. Amavita produces regulator-ready English or Spanish documentation and issues a signed certificate of accuracy; where a document is in a third language and a perito traductor is required, we route to a licensed one in-country.
Primary source

ANVISA — Brazil

Agência Nacional de Vigilância Sanitária

Instrument
Resolução da Diretoria Colegiada — RDC nº 751, de 15 de setembro de 2022
Published
15 September 2022 (Diário Oficial da União)
Article / clause
Art. 10 §§9-10 (dossier documents vs. patient-facing materials); Art. 13 II and Art. 14 III-IV (imported-device manufacturer declarations and foreign certificates); Art. 46 I (labeling language)
What the rule says
Petition forms, IFUs/user manuals, and label mock-ups must be in Portuguese. All other dossier documents may be in Portuguese, Spanish, or English. Manufacturer declarations for imported devices must be in Portuguese, English, or Spanish, or accompanied by a sworn translation (tradução juramentada). Foreign registration and free-sale certificates must be consularized or apostilled and, if not already in Portuguese, English, or Spanish, accompanied by a sworn translation.
Our reading
Brazil is the most language-plural regulator in this matrix for the technical dossier body — Portuguese, Spanish, and English are all acceptable. But everything the patient or clinician touches (forms, IFUs, labels) must be in Brazilian Portuguese, no exceptions. Sworn translation is only triggered when a specific foreign document (manufacturer declaration, foreign certificate) is in a fourth language. Amavita translates dossier body to pt-BR when the client prefers a fully Portuguese submission, or leaves it in English/Spanish where accepted, and routes the sworn-translation step to a Brazilian tradutor juramentado when required.
Primary source

INVIMA — Colombia

Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Instrument
Decreto 4725 de 2005
Published
26 December 2005
Article / clause
Artículo 49 (idioma de la información técnica y científica); Artículo 44 (authentication and translation of foreign-issued documents); Artículos 54, 56, 57 (Spanish-language labeling and inserts)
What the rule says
Art. 49: Technical or scientific information may be submitted in English, accompanied by an official translation into Spanish (traducción oficial). Art. 44: Documents issued abroad that are not in Spanish require official translation. Art. 56: Inserts must contain, in Spanish, sufficient information to ensure appropriate execution of the procedure and safe use. Art. 57: Imported-device labels may be accepted as originally issued but must carry an additional Spanish-language label or sticker.
Our reading
English is accepted as a source language, but only when paired with an official Spanish translation — English alone will not clear submission. "Traducción oficial" in Colombia is the equivalent of certified/sworn translation and is a legally reserved title (traductor oficial licensed by the Ministerio de Relaciones Exteriores). Amavita produces regulator-ready Colombian Spanish and issues a certificate of accuracy; where the filing specifically requires "traducción oficial," we route the sworn step to a licensed traductor oficial in Colombia and price it separately.
Primary source

ANMAT — Argentina

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Instrument
Disposición ANMAT N° 2318/02 (Texto Ordenado 2004) — Reglamento Técnico Mercosur de Registro de Productos Médicos (incorporating MERCOSUR/GMC/RES. N° 40/00)
Published
Original 23 May 2002 (Boletín Oficial N° 29939); consolidated text ordered 1 March 2004 (Disposición ANMAT N° 2/2004)
Article / clause
Anexo III.B Art. 1.1 (labels and IFUs); Anexo III document requirements for imported products (free-sale certificates, manufacturer authorization letters, GMP certificates)
What the rule says
Labels and instructions for use must be written in the language of the Mercosur State where registration is sought — that is, Spanish (castellano) for Argentina. For imported-product legal documents: if in a language other than Spanish, they must be accompanied by a translation performed by a traductor público matriculado (licensed public translator) and duly legalized by the Colegio de Traductores Públicos.
Our reading
Argentina is the strictest of the eight on sworn translation for legal-instrument documents — a matriculated public translator followed by legalization by the Colegio de Traductores Públicos is not optional. English is not carved out. The dossier body is in Spanish. Amavita produces Argentine regulatory Spanish (producto médico terminology, not dispositivo médico) and issues a certificate of accuracy; the sworn step on legal documents (free-sale certificate, GMP certificate, manufacturer authorization) is routed to a matriculated traductor público in Argentina and priced separately.
Primary source

ISP — Chile

Instituto de Salud Pública de Chile

Instrument
Decreto Supremo N° 825/1998 (Ministerio de Salud) — Reglamento de Control de Productos y Elementos de Uso Médico. Language and labeling practice further detailed in ISP's non-binding technical guidance: Guía de Principios Esenciales de Seguridad y Desempeño de Dispositivos Médicos y DMDIV.
Published
Decree promulgated 30 November 1998; published in the Diario Oficial 21 August 1999
Article / clause
Decreto 825 Art. 21 numeral 6 (foreign export certificates for imported Class I devices — no explicit translation clause in the decree). Operative Spanish-labeling rule sits in ISP guidance §4.13 and §4.13.4.1, not in the decree itself.
What the rule says
ISP Guía §4.13: Medical devices and IVDs must be accompanied by the necessary information in Spanish (castellano), with other languages optionally included; instructions for use must be drafted in terms easily comprehensible to the intended user, in Spanish. §4.13.4.1: Manufacturer-provided information and instructions must be in Spanish and easy to understand and use. Decreto 825 Art. 21(6): Foreign export certificates must be authorized by the country of origin's competent authority and duly legalized — the decree text as retrieved does not specify a translation mechanism for non-Spanish certificates.
Our reading
Chile is the outlier in this matrix: the base decree does not contain a standalone foreign-language article, so the Spanish-only rule for labels and IFUs is technically administrative guidance rather than statutory. In practice, ISP requests certified translations for foreign documents case by case, often via the Chilean Ministerio de Relaciones Exteriores translation unit. Amavita produces Chilean regulatory Spanish for labels and IFUs and, for the dossier body, works to the same standard even though the decree does not codify it; where ISP requests a certified translation on a specific document, we route it in-country. Note: Chile expanded mandatory device registration in March 2026 (Decreto Exento N° 25/2026), which may prompt updated procedural guidance from ISP.
Primary source
Confidence
Medium — the base decree was verified directly but contains no explicit foreign-language article; the Spanish-labeling rule is documented in ISP's own guidance PDF (administrative, not law). Regulatory-affairs teams should confirm current sworn-translation practice with ISP directly for their specific filing.

DIGEMID — Peru

Dirección General de Medicamentos, Insumos y Drogas (device-specific registration authority is the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios — ANM — under the same regulation)

Instrument
Decreto Supremo N° 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios
Published
27 July 2011 (Diario Oficial El Peruano)
Article / clause
Artículo 137 (labeling and IFU language for medical devices); general dispositions on foreign-issued documents (simple translation requirement, referenced across import-related articles)
What the rule says
Art. 137(a): Labeling on immediate and outer packaging and on IFUs for medical devices must be in Spanish, with indelible, easily legible, visible characters. Additionally, information may be presented in other languages alongside Spanish, provided it matches the information in the device's sanitary registration. Foreign-issued documents must not be older than 2 years and must be accompanied by a simple Spanish translation (traducción simple).
Our reading
Peru is the most permissive on translation of foreign documents — the decree explicitly requires only "traducción simple" (a plain, non-sworn translation), not a certified or sworn translation. This is a notable exception in the LATAM matrix. Labels and IFUs must be in Spanish; other languages may be added, but Spanish is mandatory. Amavita produces regulator-ready Peruvian Spanish and issues a certificate of accuracy — no sworn step is required by the decree itself, though DIGEMID reviewers may request higher-quality translations for critical documents in practice.
Primary source

ARCSA — Ecuador

Agencia Nacional de Regulación, Control y Vigilancia Sanitaria

Instrument
Resolución No. ARCSA-DE-2026-003-DASP — Normativa Técnica Sanitaria Sustitutiva para la obtención del registro sanitario, control y vigilancia de dispositivos médicos de uso humano (repeals prior Resolución ARCSA-DE-026-2016-YMIH)
Published
Signed 28 April 2026; enters into force 28 January 2027 (nine-month transition). During the transition, the prior 2016 resolution remains technically operative.
Article / clause
Artículo 12 (idioma de los documentos técnicos); Artículo 13 (idioma y legalización de documentos legales emitidos por autoridades extranjeras)
What the rule says
Art. 12: Technical documents for the medical device submitted for sanitary registration, modification, or re-inscription must be presented in Spanish (castellano) or English. Art. 13: Legal documents issued by foreign authorities must be presented in Spanish or English, apostilled or consularized. Where foreign legal documents are in a language other than Spanish or English, translation must be performed by a traductor titulado (qualified/certified translator) or by centers authorized for that purpose, maintaining consistency with the original.
Our reading
Ecuador is the most permissive of the eight on English acceptance — English is on equal legal footing with Spanish for both the technical dossier and foreign legal documents under the 2026 resolution. Sworn/qualified translation is only triggered when a foreign document is in a third language. This is a significant liberalization from the 2016 resolution. Amavita produces regulator-ready English or Ecuadorian Spanish and issues a certificate of accuracy. Note: teams filing before 28 January 2027 should verify which resolution ARCSA will apply to their specific submission during the transition.
Primary source

MINSA — Panama

Ministerio de Salud — Dirección Nacional de Dispositivos Médicos

Instrument
Decreto Ejecutivo N° 490 de 4 de octubre de 2019 (regulates Ley 90 de 2017, as modified by Ley 92 de 2019). A draft replacement decree was under public consultation as of late 2025 and early 2026 but has not been promulgated.
Published
4 October 2019 (Gaceta Oficial Digital N° 28875-A)
Article / clause
Provisions on foreign legal documents for Certificado de Criterio Técnico, Certificado de Verificación Técnica, and Licencia de Operación (apostille or consular legalization and Spanish translation requirement); Article 32 (Spanish labeling and IFU requirement, per regulatory summaries); IFU/inserto language provision allowing bilingual presentation provided Spanish is included
What the rule says
Foreign legal documents used to obtain Certificado de Criterio Técnico, Certificado de Verificación Técnica, and Licencia de Operaciones that come from abroad and are in languages other than Spanish must comply with general evidentiary principles — authenticated per the Apostille Convention or consular legalization — and, if the original is in a language other than Spanish, accompanied by a Spanish translation performed by a traductor público autorizado de la República de Panamá (Panama-authorized sworn public translator). Instructions for use may be printed in two or more languages, provided Spanish is one of them. Data sheets, product data, and service manuals may be presented in Spanish or English.
Our reading
Panama is strict on sworn translation for legal-instrument documents — and specifically requires a Panama-authorized public translator, licensed under Panama's own Ministerio de Educación traductor público regime, not any Latin-American sworn translator. English is carved out for technical materials (data sheets, service manuals) and for bilingual IFUs, but core legal documents from abroad require the Panama-specific sworn Spanish translation. Amavita produces regulator-ready Panamanian Spanish for labels, IFUs, and dossier body, and routes the sworn step on legal documents to a traductor público autorizado de la República de Panamá.
Primary source
Confidence
Medium-High — sworn-translation and bilingual-labeling clauses were verified from a full-text reproduction of the decree, and the decree's continued validity was confirmed on MINSA's DNDM webpage. Exact article numbers for the language clauses were not independently isolated from the raw Gaceta Oficial PDF; teams should verify the precise article citation against the official Gaceta before external filing. Panama's medical-device regulatory framework is also in transition, with a draft replacement decree under review.

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The full LATAM Regulatory Translation Matrix as a 13-page PDF. Every language rule cited to the primary instrument. Refreshed against 2024–2025 revisions.

REF: LATAM-MTX-2024
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How to challenge a citation

If any citation on this page is wrong — a superseded instrument, a wrong article number, a translation of the rule we got backwards — write to hello@amavitasciences.com with the correction and the source. We update the matrix within 48 hours and credit the sender.

Matrix last regenerated: 26 July 2026. Amavita Sciences™ is not a law firm. This page is educational summary of publicly available regulation, not legal advice. Foreign-language requirements move; verify against the primary source before filing.

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