Spanish Is Not One Regulatory Language

By Julio G. Martinez-Clark, CEO, bioaccess

Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. Send the instructions for use (IFU), labeling, protocol, investigator brochure, or technical dossier to a translation vendor. Receive Spanish and Portuguese files. Submit. Move on.

That model is too shallow for Latin America. The issue is not whether a sentence is grammatically correct. The issue is whether the translated document is usable by the regulator, investigator, distributor, patient, and postmarket vigilance system in the country where the device will be reviewed, used, and monitored.

This is why “bad translation causes delays” is not the real story. That is true everywhere. The more important LATAM-specific problem is that Spanish and Portuguese are not generic submission languages. They are regulatory operating languages, and each country gives them different consequences.

Translation Is A Control Point

For medical devices, translation is part of the risk control architecture. The IFU is not a brochure. It tells the user the intended purpose, correct use, contraindications, warnings, precautions, installation requirements, maintenance steps, and conditions for safe performance.

Brazil’s RDC 751/2022 defines instructions for use as the document containing manufacturer-provided information that clarifies the device’s intended purpose, correct use, and precautions. The same regulation requires application forms, IFUs, user/operator manuals, and labeling models to be submitted in Portuguese, and it requires device labels and IFUs to be written in Portuguese.¹

Mexico’s NOM-137-SSA1-2025 makes the same point in Spanish. It defines instructions for use as information provided by the manufacturer to inform the user of the device’s indication for use, contraindications, warnings, and precautions so the device can be used safely and correctly. It also requires health information related to identification, technical description, intended use, and correct use to appear in Spanish, in understandable terms and legible typography.²

Those rules should change how medical device manufacturers think about translation. If the translated IFU changes the meaning of a warning, weakens a contraindication, uses the wrong procedural verb, or introduces ambiguity about intended use, the problem is not linguistic polish. It is a product-risk problem.

Neutral Spanish Is Not Enough

The phrase “Latin American Spanish” is useful for a rate card. It is less useful for a regulatory file.

Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), Chile’s Instituto de Salud Pública (ISP), Peru’s Dirección General de Medicamentos, Insumos y Drogas (DIGEMID), Ecuador’s Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), and Panama’s Ministerio de Salud all operate in Spanish. But they do not always use Spanish the same way.

Even basic device identification language varies in practice. Chile’s ISP forms ask for the device’s generic name and model descriptions in Spanish or castellano, and its guidance for device acquisition states that labels and user manuals should include required information in castellano.³ INVIMA’s labeling guide is specific to Colombian medical devices and biomedical equipment, not to a region-wide Spanish convention.⁴ Mexico’s labeling rule uses its own definitions for etiquetado, instrucciones de uso, contraindicación, advertencia, and información sanitaria.²

That means a manufacturer should not approve one “neutral” Spanish package and assume it is equally ready for Colombia, Mexico, Chile, Argentina, Peru, and Ecuador. The terminology may be understandable. That is not the same as regulator-ready.

Portuguese Is Not A Spanish Extension

Brazil deserves separate treatment. Portuguese for ANVISA is not a secondary pass after Spanish translation. It is a different regulatory environment.

RDC 751/2022 requires Portuguese for labels and IFUs and places those documents inside a broader technical-dossier structure that includes device description, nonclinical evidence, clinical evidence, labeling and IFUs, and quality-system information.¹ ANVISA’s implementation materials also note that technical dossier documents used to prove safety and effectiveness that are not in Portuguese, English, or Spanish must be translated.⁵

Brazil also has a separate sworn translation framework. Law 14,195/2021 regulates the profession of tradutor e intérprete público and states that public translators and interpreters perform official translations when required by law and translate documents that must be presented in another language before entities of domestic public law or notarial and registry services.⁶

This matters because English-speaking manufacturers often collapse three different questions into one: Does the document need Portuguese? Does it need a sworn or official translation? Does it need regulatory/clinical review by someone who understands the device and the ANVISA submission context? Those are not the same question.

“Certified,” “Official,” And “Sworn” Are Not Synonyms

One of the most common LATAM mistakes is using English vendor language to describe local legal categories.

In the United States, a “certified translation” often means a translator or agency signs a statement of accuracy. In LATAM, some filings require an official, sworn, public, or locally recognized translator, depending on the country and document type.

Colombia illustrates the distinction. Resolution 1959 of 2020 defines traducción oficial as a translation that must be performed by a traductor oficial to have legal effect, and defines traductor oficial as a person accredited under Article 33 of Law 962 of 2005 or successor rules.⁷ Colombia’s foreign ministry also states that official translations made in Colombia that have legal effect in the country are not apostilled or legalized because the official translator’s signature is already valid domestically, although the source document may still need apostille or legalization when required.⁸

Argentina has its own structure. Law 20,305 governs the profession of traductor público in the Capital Federal and requires, among other conditions, a qualifying degree and professional registration. It also states that documents in a foreign language presented before public offices or judicial authorities must be accompanied by the respective Spanish translation when required.⁹

A manufacturer that treats “certified,” “official,” “sworn,” and “public” as interchangeable can create avoidable filing friction. The file may be translated, but not in the form the receiving authority expects.

Informed Consent And IFUs Carry Different Risks

Not every document in a LATAM program needs the same translation pathway.

An IFU, device label, implant card, field safety notice, informed consent form, protocol synopsis, investigator brochure, legal power of attorney, and adverse event narrative each serve a different function. Some are patient-facing. Some are investigator-facing. Some are regulator-facing. Some are legal instruments. Some may need official or sworn treatment; others need medical accuracy, formatting control, and country-specific terminology review.

This is where many companies lose time. They create one vendor workflow and push every document through it. The result may be over-certification of low-risk documents, under-review of high-risk documents, or missed requirements for legal documents. Worse, the formatting and version control discipline required for clinical and regulatory files may break during translation.

For example, informed consent forms must preserve risk descriptions, rights language, procedure descriptions, visit schedules, compensation language, signature blocks, version dates, and ethics committee-approved wording. IFUs must preserve intended use, warnings, contraindications, setup steps, troubleshooting, maintenance, cleaning, storage, and disposal instructions. Legal documents may require a translator credential, notarization, apostille, or legalization sequence.

These are different workflows. Treating them as one “Spanish translation” task is how small language decisions become submission delays.

Postmarket Vigilance Multiplies The Problem

The translation issue does not end after approval. It becomes more important after launch.

Brazil’s ANVISA technovigilance data come from adverse event and technical complaint notifications submitted through Notivisa. ANVISA’s public materials note that reports include adverse events, technical complaints, product categories, technical product names, intrinsic risk class, complaint coding, event coding, field actions, and health alerts.¹⁰

INVIMA’s national technovigilance program requires reporting of adverse events or incidents related to medical devices and tracks safety reports, alerts, recalls, and thefts involving marketed devices, importers, and manufacturers.¹¹ Mexico’s NOM-240-SSA1-2012 defines technovigilance as a system intended to ensure that marketed medical devices function according to the manufacturer’s intended use and that corrective actions are taken to reduce recurrence of adverse incidents.¹²

That means translated terminology has to work not only for submission review but also for complaint intake, distributor training, field actions, and vigilance reports. If the distributor uses one Spanish term, the IFU uses another, the complaint form uses a third, and the regulator’s portal expects a fourth, the manufacturer’s quality system loses signal.

Poor terminology control can make adverse event coding harder, obscure repeat complaints, and weaken the link between user feedback and corrective action. That is not a translation problem. It is a quality system problem.

A Practical Decision Tree

Medical device manufacturers should stop asking, “Can this be translated into Spanish?” The better question is, “What regulatory function will this document perform?”

A practical LATAM translation workflow should separate documents into five categories:

• User risk documents: IFUs, labels, warnings, contraindications, implant cards, patient guides, and quick-reference guides.
• Clinical trial documents: protocols, informed consent forms, investigator brochures, case report forms, monitoring letters, and ethics committee responses.
• Legal documents: powers of attorney, corporate certificates, certificates of free sale, manufacturing authorizations, insurance policies, and representation letters.
• Quality and postmarket documents: complaint forms, field safety notices, recall communications, vigilance narratives, CAPA summaries, and distributor training materials.
• Technical dossier documents: safety and performance evidence, test reports, software descriptions, risk management files, and manufacturing information.

Each category should have its own rule set. Which country will receive it? Which regulator will read it? Is it patient-facing, investigator-facing, regulator-facing, or legal? Does it need a sworn or official translator? Does it require medical review? Does it need layout preservation? Does it need version traceability? Will the same terminology flow into postmarket vigilance?

That decision tree is more useful than a generic vendor checklist.

The Real Question For Manufacturers

LATAM translation is not one row on a global language rate card. It is a country-specific regulatory control process that touches safe use, submission completeness, legal validity, trial start-up, distributor training, complaint handling, and postmarket accountability.

The companies that manage it well will not necessarily spend more. They will spend earlier, classify documents more intelligently, and route them through the right review path before submission.

The companies that treat Spanish and Portuguese as generic deliverables may still receive polished files. They may even receive them on time. But they may not receive files that work in the regulatory system where the device must be approved, used, monitored, and defended.

That is the board-level point. For LATAM medtech programs, translation is not an administrative step after strategy. It is part of the strategy.

References

1. Agência Nacional de Vigilância Sanitária (ANVISA), “Resolução RDC nº 751, de 15 de setembro de 2022,” https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-751-de-15-de-setembro-de-2022-430797145
2. Diario Oficial de la Federación, “Norma Oficial Mexicana NOM-137-SSA1-2025, Etiquetado de dispositivos médicos,” https://dof.gob.mx/normasOficiales/9557/salud/salud.html
3. Instituto de Salud Pública de Chile (ISP), “Guía para la adquisición de dispositivos médicos en las instituciones de salud,” https://www.ispch.cl/sites/default/files/1_Guia_para_la_Adquisicion_de_Dispositivos_Medicos
   _en_las_Instituciones_de_Salud.pdf
4. Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), “Guía digital etiquetado de dispositivos médicos y equipos biomédicos,” https://www.invima.gov.co/invima_website/static/attachments/dispositivos_dispositivos_medicos
   _equipos_biomedicos/GU_C3_8DA_20DIGITAL_20ETIQUETADO_20DE_20DISPOSITIVOS
   _20M_C3_89DICOS_20Y_20EQUIPOS_20BIOM_C3_89DICOS_20_1_.pdf
5. ANVISA, “Relação de Documentos de Instrução — Equipamento — Registro de Equipamento,” https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/produtos-para-a-saude/formularios-1/documentos-de-instrucao-equipamentos-para-saude.pdf
6. Presidência da República, “Lei nº 14.195, de 26 de agosto de 2021,” https://www.planalto.gov.br/ccivil_03/_ato2019-2022/2021/lei/l14195.htm
7. Ministerio de Relaciones Exteriores de Colombia, “Resolución 1959 de 2020,” https://www.cancilleria.gov.co/sites/default/files/Normograma/docs/resolucion_minrelaciones
   _1959_2020.htm
8. Ministerio de Relaciones Exteriores de Colombia, “Traducciones oficiales,” https://www.cancilleria.gov.co/tt_ss/traducciones-oficiales
9. Argentina.gob.ar, “Ley 20.305 — Traductores Públicos,” https://www.argentina.gob.ar/normativa/nacional/ley-20305-194196/texto
10. ANVISA, “Tecnovigilância,” https://www.gov.br/anvisa/pt-br/acessoainformacao/dadosabertos/informacoes-analiticas/tecnovigilancia
11. INVIMA, “Programa nacional de tecnovigilancia,” https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/programa-nacional-de-tecnovigilancia
12. Diario Oficial de la Federación, “NOM-240-SSA1-2012, Instalación y operación de la tecnovigilancia,” https://sidof.segob.gob.mx/notas/docFuente/5275834

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the Global Trial Accelerators podcast. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).