Spanish-Language Specifications and Product Description Requirements in Guatemala

1. Key takeaways

Guatemalan device registration requires two independent Spanish-language documents: the finished product specifications (Especificaciones de producto terminado, Article 5.1.3 of NT-37) and the product description (Descripción del producto, Article 5.1.4). The former carries the technical parameters and acceptance criteria; the latter states what the product is, what it does and how it is used. Both must be in Spanish, and where the original document exists in another language it must be translated under Article 5.2.5 by a sworn translator authorised in the Republic of Guatemala. Keeping the two documents separate, in the correct language and mutually consistent, is what allows the reviewer to verify quality control on one hand and to confirm intended use and classification on the other, so the way these two files are drafted and translated directly shapes the course of the review.

• Specifications and description are two separate dossier items with two separate clause numbers, and merging them is not accepted.
• Both documents must be presented in Spanish.
• Non-Spanish originals require translation by a sworn translator authorised in Guatemala.
• The specifications become the benchmark against which post-market enforcement compares the product throughout the life of the registration.
• The description is read together with the packaging when the reviewer confirms intended use and classification.
• Translation errors in units, tolerances or material designations feed directly into the revocation test of Article 11.3.
• Specification parameters should match the quality control certificate so that the quality loop closes without contradictions.

2. Legal basis

The table below gathers the clauses that define, govern and enforce the two Spanish-language documents. Read together, they show that the specifications and the description are not isolated filing formalities but documents with consequences across the full lifecycle of the registration, from initial review to revocation.

3. Expert insights

Insight one: separating specifications from description creates two documents with two different purposes. Articles 5.1.3 and 5.1.4 are independent item numbers, which signals that the authority does not accept a merged “product leaflet” covering both. The specifications serve the reviewer as the basis for checking quality control, while the description serves as the basis for judging intended use and classification. Drafting one document that tries to do both jobs blurs the reference points the reviewer relies on, and a submission organised this way invites queries that a cleanly split file would never have attracted.

Insight two: the specifications become the comparison benchmark for later enforcement. Article 11.3 lists non-compliance with the quality control established in the manufacturer’s specifications as a ground for revoking the registration. This means the specifications submitted under Article 5.1.3 are not just filing material; they remain the frame of reference for market surveillance and for any revocation assessment after approval. Writing the specifications in overly demanding terms effectively sets a higher compliance line for the product’s entire market life, so parameter selection deserves the same care as the marketing claims themselves.

Insight three: the description and the classification decision corroborate each other. When the reviewer judges external or internal use, and whether the product is sterile, the primary reference is the product description of Article 5.1.4 read together with the packaging of Article 5.1.10. If the use language in the description does not match the classification outcome, the mismatch can trigger a reclassification or even refusal of registration under Article 10.4. Aligning the wording of the description with the class actually sought is therefore a drafting discipline, not a stylistic preference.

Insight four: translation is a content risk, not merely a language matter. Article 5.2.5 requires translation by a locally authorised sworn translator, but the substantive danger lies in technical mistranslation — units, tolerances and material designations are the classic failure points, and an error in any of them feeds directly into the comparison that Article 11.3 performs. The finished translation should therefore be reviewed and confirmed by the technical side, not finalised by the translator alone, so that what the reviewer reads in Spanish is exactly what the manufacturer intends to commit to. In short, the two Spanish documents are the pivot on which the whole quality argument of the dossier turns.

4. Practical recommendations

• Prepare the specifications and the description as two separate documents and never merge them into one submission.
• Keep the parameters in the specifications consistent with the quality control certificate of Article 5.1.9, avoiding self-imposed thresholds that are higher than necessary.
• Align the use language of the description across three points: the classification outcome, the label and the package insert.
• Arrange sworn translation of non-Spanish originals by a translator authorised in Guatemala, followed by technical review of terminology and units.
• Bring specification versions under change management so that parameter changes are processed through the Article 6 procedure without delay.

5. Verification checklist

• □ Specifications and description have been prepared as two separate documents
• □ Both documents are in Spanish
• □ Specification parameters are consistent with the quality control certificate
• □ Description use language is aligned with the classification outcome, label and insert
• □ Translation has been completed by a locally authorised sworn translator and reviewed by the technical side
• □ Specification versions are under change management

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 Guatemalan market. Our team manages Ministry of Public Health and Social Assistance (MSPAS) registrations, coordinates import and distributor requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com