Foreign Documents: Translation and Apostille

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, sets two uniform rules for foreign documents: Article 32, item 12 (at the classification stage) and point 5 of the final paragraph of Article 75 (for the special import authorisation) both require that documents originating abroad and not in the official language, Spanish, be appropriately translated; change documents must in addition be apostilled (apostillado) or authenticated (autenticado). Article 52, item 3, applies this requirement to many of the twelve types of change: changes of company name, validity period, storage conditions, product presentation, chemical composition, product holder, manufacturer and country of origin, and registering company all require foreign documents to be apostilled or authenticated. For powers of attorney, Article 43, item 15, requires a notarised power of attorney or a letter of attorney with its certification of authenticity (poder en escritura pública o carta poder con su certificado de autenticidad). The GRZAN regulatory team notes: this market’s practical estimate for handling foreign documents is to translate into Spanish first, then obtain authentication; the order must not be reversed, and neither step may be skipped.

2. Legal basis

The table below maps the requirements for foreign documents to their provisions and key points.

3. Expert insights

Insight 1: translation plus authentication are two independent requirements, not alternatives. Article 32, item 12, says debidamente traducidos y autenticados — translation and authentication stand side by side. The various change items of Article 52, item 3, repeatedly say apostillado o autenticado. The GRZAN regulatory team’s approach is to have a sworn translator render the document into Spanish first, then apostille or consular-authenticate the original (or the translation), depending on whether the issuing country is a member of the Hague Convention.

Insight 2: apostille and consular authentication are alternatives; authentication and Foreign Affairs legalisation sit on different tracks. Article 52 says apostillado o autenticado — apostille or consular authentication, one of the two, depending on the issuing country. By contrast, Article 84, Section 3 c), requires labels to be traducidas y debidamente legalizadas por relaciones exteriores — translated and duly legalised by the Ministry of Foreign Affairs. This is a label-specific route, distinct from the document authentication route.

Insight 3: the threshold for powers of attorney is fixed by Article 43, item 15, as a notarised deed or a letter of attorney with certification. The provision reads poder en escritura pública o carta poder con su certificado de autenticidad. In other words: either a notarised power of attorney (escritura pública) or a letter of attorney (carta poder) with its certification; the latter costs less but must carry the certification. Article 32, item 9, is more relaxed at the classification stage: the power of attorney carries its certification cuando aplique — when applicable.

Insight 4: seven of the twelve types of change trigger authentication of foreign documents. Article 52, item 3 a) company name, b) validity period, c) storage conditions, e) product presentation, h) chemical composition, j) product holder, and k) manufacturer and country of origin all require foreign documents to be apostilled or authenticated. This means almost any change involving a foreign party requires authentication, whereas purely domestic changes (f legal representative, i cessation of manufacture, l domestic registering company) need only paper documents with certification.

Insight 5: the time cost of authentication must be built into change scheduling. Apostille or consular authentication is usually obtained in the country where the document was issued; adding translation time, the overall cycle is often longer than ARSA’s review period. The GRZAN regulatory team recommends setting up a standing power of attorney mechanism in distribution agreements or group internal processes — preparing and holding several authenticated product holder powers of attorney in advance, so that every change does not start from zero.

4. Practical recommendations

• Handle all foreign documents as translate into Spanish first, then apostille or consular authentication, without reversing the order.
• Process labels through the Foreign Affairs legalisation route, separately from document authentication; do not mix the two.
• Choose, per Article 43, item 15, between the notarised power of attorney and the letter of attorney with certification, and budget accordingly.
• List translation and authentication cycles separately in change schedules; do not merge them with ARSA review periods.
• Set up a standing power of attorney mechanism within the group, holding several authenticated product holder powers of attorney in advance.
• Handle purely domestic changes (legal representative, cessation of manufacture, domestic registering company) as paper documents with certification, without apostille.

5. Verification checklist

• □ Foreign documents have been processed in two steps, translation plus authentication
• □ Label translations have been legalised by the Ministry of Foreign Affairs
• □ Powers of attorney have been executed as notarised deeds or letters of attorney with certification
• □ Change schedules list translation and authentication cycles separately
• □ A standing power of attorney mechanism is in place
• □ Purely domestic changes were handled as paper documents with certification

Related reading: [Article 14 — The thirteen classification report documents](/honduras-medical-device-registration/classification-report-requirements-article-32/) | [Article 41 — The twelve types of post-registration change](/honduras-medical-device-registration/post-registration-changes-twelve-types/) | [Article 31 — The Titular and the registering company](/honduras-medical-device-registration/titular-and-registrante/)

Regulatory information verified as of October 29, 2026.

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