Spanish Language Requirements and the Scope of Official Translation

1. Key takeaways

Article 10.13 of the main regulation establishes the general language rule: all documents submitted for registration purposes must be submitted in Spanish; where the original is not in Spanish, the corresponding translation must be attached; and documents that are official or legal in nature must be accompanied by an official translation (traducción oficial). Article 12.2, however, sets a lower requirement for the clinical evidence of Clase 3 — only a simple translation (traducción simple) is required. In addition, Article 19.1 requires label information to be in Spanish, and Article 19.3 requires the instructions for use and manuals supplied with the product to be in Spanish.

• The dividing line runs by issuing entity: documents issued by government authorities or through legal procedures need an official translation, internal technical documents need only a corresponding translation.
• Article 12.2 is the only simple-translation clause in the regulation, and it covers only clinical evidence.
• Labels may follow the original-label plus supplementary-label route under Article 19.1.
• Instructions for use and manuals have no such alternative: Article 19.3 demands Spanish directly.
• Language requirements stack with the certification requirements of Article 10.17 — one layer does not replace another.

2. Legal basis

The language rules are spread across several provisions, from the general rule of Article 10.13 to the product-level requirements of Articles 19.1 and 19.3, as mapped below.

3. Expert insights

Insight 1. Article 10.13 splits documents into two classes with different translation requirements: ordinary documents take a corresponding translation, while official or legal documents take an official translation. This is the core dividing line of the Costa Rican language regime. The CLV, the BPM certificate, the letter of authorisation and entity-status documents are official or legal in nature and require an official translation issued by a translator or body officially recognised in Costa Rica; internal technical documents such as the technical and medical specifications need only the corresponding translation. The test is the issuing entity — documents issued by a government authority or through a legal procedure are official or legal in nature.

Insight 2. Article 12.2 is the only simple-translation clause in the regulation, and it targets clinical evidence alone. The text reads esta evidencia debe acompañarse de una traducción simple en caso de no estar en idioma español. This is an explicit downgrade: the six categories of evidence — clinical evaluation documents, preclinical studies, human studies, software verification studies, literature studies and the risk analysis summary — need not undergo official translation. For Clase 3 and Clase 4 projects, this clause can materially reduce translation cost and time.

Insight 3. Articles 19.1 and 19.3 extend the language requirement to the product itself, and Article 19.3 admits no exception. Article 19.1 allows the original label to be in a non-Spanish language, with a supplementary label translating the mandatory information (a design discussed in its own article); Article 19.3, by contrast, requires the instructions for use and manuals to be deben estar en idioma español — directly in Spanish, with no supplementary-document channel. The meaning is that labels can take the original-plus-supplement approach, while instructions for use and manuals must be provided directly in Spanish.

Insight 4. The language requirements and the certification requirements of Article 10.17 are cumulative, not substitutive. A foreign-issued official document must satisfy all of the following at once: consular legalisation or apostille (first part of 10.17), official translation (10.13), and notarial certification of the digital signature (second part of 10.17). The three layers are independent of one another; completing one does not waive the others. This is the area where items are most easily missed in Costa Rican dossier preparation.

4. Practical recommendations

• Build a document classification list: separate official or legal documents from ordinary technical documents by issuing entity, applying official translations and ordinary translations respectively.
• For Clase 3 and Clase 4 clinical evidence, apply a simple translation under Article 12.2 and assert that entitlement expressly, so as not to be asked for an official translation.
• Handle labels through the original-label plus supplementary-label route of Article 19.1; provide instructions for use and manuals directly in Spanish under Article 19.3.
• Check the three layers for foreign official documents — legalisation, official translation, notarial certification — item by item, keeping the receipt for each.
• Archive translations and originals together under a single numbering scheme, noting the translator and the issue date for review comparison.

5. Verification checklist

• □ Document classes distinguished under Article 10.13
• □ Official or legal documents officially translated
• □ Ordinary technical documents accompanied by corresponding translations (11.4)
• □ Clase 3 clinical evidence simply translated under Article 12.2
• □ Labels handled through the original-plus-supplementary-label route (19.1)
• □ Instructions for use and manuals in Spanish (19.3)
• □ Three-layer requirements for foreign documents completed with receipts

Related reading: [Legalisation, apostille and the two-year default validity of foreign documents](/costa-rica-medical-device-registration/foreign-documents-apostille-and-notarial-certification/) | [Eighteen mandatory label items and the two classes of warnings](/costa-rica-medical-device-registration/labelling-eighteen-mandatory-items/) | [Clase 3 route: six clinical evidence items and the IVD alternative channel](/costa-rica-medical-device-registration/class-3-clinical-evidence-six-items/)

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 Costa Rican market. Our team manages Ministry of Health (Ministerio de Salud) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com