Translate Instructions for Use into Portuguese
INFARMED and ANVISA-compliant IFU translations for Portugal and Brazil
The Portuguese language connects two of the most important medical technology markets for European manufacturers: Portugal within the EU and Brazil as the largest market in Latin America. With a Portuguese-speaking global population of over 260 million people and a Brazilian medical device market volume of approximately 11 billion euros, Portuguese is a strategically indispensable language for internationally operating manufacturers.
The greatest linguistic challenge lies in the fundamental differences between European Portuguese (pt-PT) and Brazilian Portuguese (pt-BR). Although the 2009 Orthographic Agreement brought some convergence, differences in medical terminology remain considerable. Anatomical designations, medical device terminology, and even basic operating instructions can differ between the variants.
The regulatory frameworks differ fundamentally. In Portugal, INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde) as the competent national authority oversees implementation of the EU MDR. Instructions for use must be available in full in European Portuguese and comply with all MDR requirements. In Brazil, ANVISA (Agência Nacional de Vigilância Sanitária) imposes its own, partially divergent requirements on product documentation — from registration numbers to specific labeling regulations.
manualworks provides an end-to-end solution for both Portuguese markets. The platform manages separate translation memories and terminology databases for pt-PT and pt-BR. Translations can be created in parallel, with variant-specific differences automatically detected and flagged. Regulatory mandatory disclosures are verified separately for both jurisdictions.
Furthermore, manualworks supports the correct application of Portuguese typographic conventions and ensures consistency of all documents across product families and revision levels.
Frequently Asked Questions
Why do I need separate translations for European and Brazilian Portuguese?+
European (pt-PT) and Brazilian Portuguese (pt-BR) differ significantly in orthography, grammar, and technical terminology. Despite the 2009 Orthographic Agreement, significant differences persist, particularly in medical terminology. Moreover, different regulatory systems apply: Portugal falls under the EU MDR and is supervised by INFARMED, while Brazil is regulated by ANVISA. A single translation cannot satisfy both requirements.
Does manualworks support ANVISA requirements for Brazil?+
Yes. In addition to EU MDR requirements for Portugal, manualworks also supports specific ANVISA (Agência Nacional de Vigilância Sanitária) requirements for the Brazilian market. The platform manages separate terminology databases for pt-PT and pt-BR and enables parallel translation into both variants with their respective regulatory requirements.