Spanish Labelling Requirements for Imported Products in Guatemala

1. Key takeaways

The Spanish-language obligations for imported devices in Guatemala concentrate on a single item: Article 7.1.2 of NT 37 provides that for imported products the instructions for use and warnings must appear on the label in Spanish. Other information may be carried on a supplementary label (etiqueta complementaria) or in the package insert (inserto), provided it is truthful, verifiable and not misleading. On the reagent side the corresponding requirement is Article 9 of NT 40 — all reagents must circulate in containers bearing a Spanish-language label, with the label legible and affixed or printed on the container, or accompanied by a supplementary label. The two sides differ in breadth: the device rule targets one specific item with surgical precision, while the reagent rule extends Spanish labelling to the entire circulating container, so reagent packaging needs a broader localisation effort than device packaging of comparable complexity.

• For imported devices, instructions for use and warnings must be in Spanish on the label.
• Supplementary labels and inserts may carry additional information, subject to the note to Article 7.
• Packaging submitted for registration must not be a photocopy or carry overlaid labels.
• Reagents must circulate in containers with a legible Spanish-language label.
• Reagent labels add the wording “Manténgase fuera del alcance de los niños” — keep out of the reach of children.
• The Spanish duty cannot be shifted onto a supplementary label.

2. Legal basis

The table below gathers the provisions on both the device and reagent sides that define where Spanish must appear and how supplementary information may be used. Read together, they delimit exactly what must be localised and what may be deferred to an insert or a supplementary label.

3. Expert insights

Insight one: Article 7.1.2 and Article 5.1.10 must be read together. The first requires the instructions for use and warnings of imported products to be in Spanish; the second forbids submitting packaging mock-ups with overlaid labels. The operational conclusion of reading the two jointly is that the Spanish information must be built into the formal packaging design or the formal mock-up, not added after importation by way of a sticker. Treating the two provisions in isolation produces the classic misalignment in which the mock-up passes review but the physical product on the market violates the clause — the paperwork is compliant while the goods are not, and the exposure surfaces only at inspection.

Insight two: the supplementary label is permitted, but on conditions. The note to Article 7 makes clear that supplementary labels and inserts may carry additional information and illustrations, provided the mandatory requirements of the standard are met and the content is truthful and verifiable. The supplementary label is therefore a legitimate compliance tool, not a channel for evading the Spanish-language requirement — the obligation of Article 7.1.2 cannot be transferred to it. Using the supplementary label for genuinely additional information while keeping the mandated Spanish item on the principal label is the arrangement the provisions were designed to support.

Insight three: the reagent side adds two requirements the device side does not have. The opening of Article 9 of NT-40 extends the Spanish-language label to the entire circulating container, and Article 9.1.6 adds the wording “keep out of the reach of children”. Reagents are largely chemical products, and these two requirements correspond to their risk profile. Reviewing reagent labelling with the device checklist alone will miss both points, so the two sides need separate audit lists even though the underlying standard structure feels familiar.

Insight four: the package insert is a legitimate carrier of information. Article 5.1.12 lists technical literature, catalogue or package insert as an optional document item (in Spanish, when applicable), and the note to Article 7 recognises the insert as a lawful location for supplementary information. For primary packaging with limited surface area, placing detailed information in the insert is a workable path — but the six mandatory items of Article 7.2 must remain on the packaging itself. The insert complements the label; it never replaces it as the home of the mandatory content.

4. Practical recommendations

• Build the instructions for use and warnings of imported products into the formal packaging design rather than relying on overlaid labels.
• Use supplementary labels to carry genuinely additional information, never to discharge the Spanish-language obligation of Article 7.1.2.
• For primary packaging with limited surface, place detailed information in a Spanish-language insert while keeping the six mandatory items on the packaging.
• For reagents, additionally verify the container-label requirements of Article 9 and the keep-out-of-reach-of-children wording.
• Pre-clear all supplementary information against the three tests: truthful, verifiable and not misleading.

5. Verification checklist

• □ Instructions for use and warnings are in Spanish for imported products
• □ The Spanish information is built into the formal packaging design
• □ Supplementary labels have not been used to substitute the mandatory Spanish obligation
• □ The six mandatory items of primary packaging remain on the packaging
• □ Reagents have been checked against the Article 9 container label and the keep-out-of-reach wording
• □ Supplementary information has been pre-cleared against the three constraints

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