Regulatory Language Infrastructure™
Medical device translation services built for LATAM registration files.
IFUs, labels, technical files, risk documentation, and clinical evidence translated directly from your origin language into Latin American Spanish and Brazilian Portuguese — checked against 12 LATAM regulators and reviewed by clinicians who have filed device dossiers in the region.
Mexico and Brazil first
The two markets most device registrations start with.
A CE or FDA device file does not convert into a COFEPRIS or ANVISA submission by language alone. Each authority has its own labeling conventions, certification rules, and expectations for how the technical file reads. We treat those as separate gates rather than one translation pass.
COFEPRIS device dossiers in Mexican Spanish
IFU and label content matched to COFEPRIS expectations and Mexican usage rather than a neutral Spanish pass, with the legal package prepared for the Mexican registration holder.
ANVISA device registration in Portuguese
Technical and clinical content in Brazilian Portuguese, with contracts and authorizations sworn by a tradutor público juramentado registered with a Junta Comercial.
One term list across the whole dossier
Device nomenclature, component names, and intended-use phrasing stay identical from the technical file to the label, so reviewers do not read two different devices.
Deficiency responses in the regulator's language
Queries translated into your working language and the response drafted, certified, and returned in Spanish or Portuguese for re-submission.
Powers of attorney, distributor letters, and corporate authorizations usually carry an authentication step before translation. See the apostille vs. sworn translation guide for LATAM →
Document scope
One service for the full device registration file.
IFUs and user manuals
Bilingual layout preserved, warnings and contraindications rendered to local labeling conventions.
Primary and secondary labels
Symbol usage, unit conventions, and mandatory statements aligned to each country's device labeling rules.
Technical file summaries
Design, performance, and verification summaries translated with a single controlled term list across the dossier.
Risk management files
ISO 14971 hazard and mitigation language translated so reviewers can trace each control.
Clinical evaluation reports
Clinical evidence and literature appraisals reviewed by a clinician before submission formatting.
Biocompatibility and sterilization
Test reports and validation summaries with consistent method and standard references.
Quality certificates
ISO 13485, CE, and FDA clearance documentation prepared for legalization and filing.
Legal instruments
Powers of attorney, distributor letters, and corporate documents routed to sworn translators where required.
How this is built differently
Registration-first translation, not language-only translation.
No English pivot
Documents move directly from your origin language into es-419 or pt-BR, so device terminology is not filtered through a second language first.
No generic LSP workflow
Every file is reviewed by a clinician and a regulatory linguist who has read the target regulator's device requirements.
No uncertified submissions
Certification, notarization, and apostille scope is fixed per jurisdiction before work begins.
No hidden delay
Tier 1-A includes a $2,500 per business day credit when a delay is caused by our delivery or a critical review error.
Pricing
Tier 1-A: $0.34–0.42/word equivalent.
Tier 1-A covers direct-origin translation into es-419 or pt-BR, Seven-Gate QC, MD-led review, regulator formatting, certification, and a $2,500 per business day delay credit. The per-word equivalent uses a 2,000-word technical document benchmark; device files are quoted per dossier.
Frequently asked questions
Answers for device regulatory affairs teams.
What are medical device translation services?
Medical device translation services render instructions for use, labels, technical files, risk documentation, and clinical evidence into the language a health authority reviews in. For LATAM that means Latin American Spanish and Brazilian Portuguese, formatted to the registration rules of each regulator.
Which device documents have to be translated for a LATAM registration?
IFUs and user manuals, primary and secondary labeling, technical file summaries, risk management files, biocompatibility and sterilization reports, clinical evaluation reports, quality certificates, and the legal instruments that accompany the application.
How does ANVISA differ from COFEPRIS for device documentation?
ANVISA reviews in Portuguese, references Brazilian RDCs, and requires legal instruments to be sworn by a tradutor público juramentado. COFEPRIS reviews in Mexican Spanish and expects labeling and IFU content aligned to its own NOM references. The same source dossier needs two different target packages.
Do IFUs and labels need certified translation?
Technical content such as IFUs, manuals, and clinical evidence is delivered as certified technical translation. Legal instruments — powers of attorney, distributor agreements, corporate authorizations — usually require sworn or apostilled translation. Certification scope is fixed per country before work starts.
How do I start a medical device translation pilot?
Submit the pilot intake at https://amavitasciences.com/start-your-latam-pilot with your device class and target market. We respond within 2 business days with a scoped proposal, timeline, and certification plan for the regulator you are filing with.
Next step
Bring us one device file and a target market.
Tell us the device class, the origin language, and the regulator you are filing with. We respond within 2 business days with a scoped proposal and certification plan.
Where to go next
The research below sets the rules; the service pages show how we run them on a live dossier.
Primary-source research
- Preclinical translation requirements across nine LATAM regulatorsPrimary-source review with the three-tier framework used to decide what to translate per country.
- Preclinical translation rules at eight non-LATAM regulatorsFDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA and Swissmedic compared against the LATAM baseline.
Platform and services
- The regulatory language platformHow the dossier pipeline, terminology control and medical review fit together.
- Clinical trial translation servicesProtocols, informed consent and site documents for LATAM submissions.
- Pharmaceutical translation servicesCTD modules, labelling and CMC documentation for drug submissions.
- Medical device translation servicesTechnical files, IFUs and clinical evaluation reports for device dossiers.