Spanish Translation: The Authorised Public Translator Threshold in Panama

1. Key takeaways

Where a foreign legal document filed with the DNDM is not in Spanish, it must be accompanied by a Spanish translation prepared by an authorised public translator of the Republic of Panama (traductor público autorizado de la República de Panamá), under the third paragraph of Article 35 of Decreto Ejecutivo N° 490. This is not a recommendation to use a professional translator. It is a statutory threshold on the qualification of the translator: the person must be an authorised public translator within Panama. A translator in the country of provenance, a Spanish-speaking member of the company staff or a machine translation does not satisfy the provision, however accurate the output may be.

The requirement sits inside a broader language architecture that has two distinct layers. Legal documents are governed by the translator qualification rule. Product documents, meaning the instructions for use under Article 38 and the labelling under Article 39, are governed instead by a language-composition rule that requires one of the languages to be Spanish and says nothing about who prepared the text. Keeping the two layers apart avoids two opposite errors: over-translating every product document through an authorised translator, which multiplies cost, and under-translating legal documents through an internal translator, which leads to the file being returned.

• Legal documents in a foreign language require a translation by a Panamanian authorised public translator.
• The rule comes from the third paragraph of Article 35, not from the general requirements of Article 36.
• Instructions for use must be in Spanish under item 8 of Article 36, but that item does not apply to biomedical equipment.
• Labels and instructions may be printed in two or more languages provided that one of them is Spanish.
• Data sheets, product data and technical service manuals for biomedical equipment may be submitted in Spanish or English.

2. Legal basis

Decreto Ejecutivo N° 490 of 4 October 2019 deals with language in several places, and the provisions should be read as a set. Article 35, third paragraph, governs the translation of legal documents. Articles 36, 38, 39 and 41 govern the language of product information and of technical documentation.

The distinction between the two layers is structural rather than stylistic. Article 35 addresses documents that have legal force of their own, such as certificates and powers, and it therefore controls who may translate them. Articles 38, 39 and 41 address information addressed to the user or the technician, and they control only which languages must appear.

3. Expert insights

Insight one: the language requirements for legal documents and for product documents operate at two different levels. The third paragraph of Article 35 governs documentos legales, meaning documents such as the certificate of free sale, the ISO 13485 certificate, the manufacturer letter of commitment and powers of attorney, and their translation must come from a Panamanian authorised public translator. Product documents, meaning the instructions under Article 38 and the labels under Article 39, are subject instead to the rule that one of the languages must be Spanish, with no constraint on the qualification of the translator. Confusing the two leads either to over-translation, where product documents are also sent to an authorised translator at double the cost, or to under-translation, where legal documents are handled internally and the file is rejected.

Insight two: technical documentation for biomedical equipment may be in English, and that is an exception. Article 41, item 1 provides that the data sheet, product data and technical service manuals may be presented in Spanish or English (podrá ser presentada en español o inglés). The provision recognises the English convention of equipment technical documentation. Its scope should be read precisely: it covers only the three categories of document listed in Article 41. Instructions for use are already disapplied for biomedical equipment under item 8 of Article 36, and labelling under Articles 39 and 40 does not apply to biomedical equipment either.

Insight three: the formula requiring one language to be Spanish permits multilingual labels and multilingual instructions. Article 38 and Article 39, item 2 both use the wording two or more languages, provided that one of them is Spanish. This means that a separate Spanish-only version does not have to be printed for Panama, and that multilingual printing is sufficient. For a manufacturer this is a significant saving, because Spanish can be built into a global multilingual label and a dedicated print run for Panama becomes unnecessary.

Insight four: symbols are permitted, but an explanatory duty comes with them. Article 39, item 1 allows internationally recognised symbols and colours on the condition that their descriptive wording is set out in the instructions for use or the package insert so as to safeguard safe use. Symbols are therefore not accepted unconditionally: each symbol must be carried by a text explanation. A label that relies on symbols alone, without a Spanish explanation, does not stand under Article 39.

4. Practical recommendations

• Maintain two separate lists, one for legal documents governed by the third paragraph of Article 35 and one for product documents governed by Articles 38 and 39, and route each document accordingly.
• Commission translations of legal documents from a Panamanian authorised public translator and keep the translator credentials and signature page on file with the translation.
• Print labels and instructions in multiple languages with Spanish included, rather than opening a Panama-specific version.
• For biomedical equipment, submit the data sheet and technical service manual in English, but keep every other document in Spanish.
• Where symbols are used, provide the Spanish explanation in the instructions or insert and build a symbol-to-text table so that the mapping is visible to the evaluator.
• Check the translator qualification before the translation is commissioned, since a correct translation by an unqualified person does not cure the defect.

5. Verification checklist

• □ Legal documents and product documents separated into two language lists
• □ Translations of legal documents issued by a Panamanian authorised public translator under the third paragraph of Article 35
• □ Instructions for use contain Spanish, or the biomedical equipment exemption is confirmed under Article 38
• □ Labels contain Spanish under Article 39, item 2
• □ English confirmed as acceptable for biomedical equipment technical documents under Article 41, item 1
• □ Symbols explained in Spanish in the instructions or package insert under Article 39, item 1
• □ Translator credentials and signature page retained with each translated legal document

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Panamanian market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 29 October 2026.