Labelling Requirements for Medical Devices under NT 37 Article 7

1. Key takeaways

The minimum labelling requirements for devices in Guatemala are set out in Article 7 of NT 37 Versión 5-2016: 10 items for the secondary packaging (product name, instructions for use and warnings, quantity or content, batch number, sanitary registration number, manufacturer name with manufacturing site and country, expiry date, the word “sterile”, dimensions, storage temperature) and 6 items for the primary packaging (product name, batch number, expiry date, sanitary registration number, the word “sterile”, dimensions). The last 4 items of the secondary list are marked as applicable when relevant. Supplementary information may be carried on a supplementary label or in the package insert, but it must be truthful, verifiable and not misleading to the consumer. Reading Article 7 as a dual checklist — one list per packaging level — is the simplest way to keep labelling design aligned with the standard from the first artwork draft onward.

• The secondary packaging list contains ten items under Articles 7.1.1 to 7.1.10.
• The primary packaging list contains six items under Articles 7.2.1 to 7.2.6, applying where secondary packaging exists.
• The last four items of the secondary list — sterile marking, dimensions and storage temperature among them — are conditional.
• For imported products, the instructions for use and warnings must be in Spanish.
• The sanitary registration number appears at both packaging levels.
• Supplementary information must be truthful, verifiable and non-misleading.

2. Legal basis

The table below reproduces the item lists of Article 7 by packaging level, together with the note that governs supplementary information. It is the reference table against which artwork should be checked before any mock-up is submitted under Article 5.1.10.

3. Expert insights

Insight one: the sanitary registration number appears at both packaging levels. Article 7.1.5 and Article 7.2.4 both require the “Número de inscripción sanitaria”. This means the registration number is not confined to the outer carton; it penetrates to the smallest sale unit. During the mock-up stage, before the registration has been granted, a space for the number must be reserved in the artwork, because obtaining the certificate afterwards and then remaking the packaging would require a change procedure under Article 6.11. Planning for the number from the first draft is therefore a scheduling protection, not a cosmetic detail.

Insight two: the Spanish-language requirement is selective, and it lands on the most critical item. Article 7.1.2 requires Spanish only for instructions for use and warnings on imported products; the remaining items carry no language stipulation. The placement is precise — the information directly tied to user safety must be localised. Companies that translate the entire label or translate nothing at all match neither reading of the clause. The practical rule is to anchor the Spanish obligation on the use-and-warnings item and treat the rest of the label as a design and market decision rather than a compliance mandate.

Insight three: the six primary-packaging items presuppose the existence of secondary packaging. The heading of Article 7.2 reads “Empaque primario (cuando exista empaque secundario)” — the primary packaging provisions apply only where secondary packaging exists. A product sold in a single pack, without a secondary level, is governed by Article 7.1 instead. This point is frequently overlooked in artwork reviews: applying the six-item primary list to a single-pack product, or failing to apply it where secondary packaging does exist, both produce misalignment with the standard’s actual structure.

Insight four: the three constraints on supplementary information are substantive. The note to Article 7 requires supplementary information to be “veraz, comprobable y no debe inducir a error o confusión del consumidor” — truthful, verifiable and not leading to error or confusion for the consumer. This draws a red line for promotional wording: indications and performance claims that exceed the registered scope fall foul of the note. Marketing teams should treat the note as a pre-clearance filter for every supplementary label and insert, because a claim that cannot be substantiated against the registration file is a compliance defect by definition.

4. Practical recommendations

• Run a dual self-check against the ten items of Article 7.1 and the six items of Article 7.2, verifying each point in turn.
• Ensure the instructions-for-use-and-warnings item is in Spanish for imported products, and localise the remaining items according to actual need.
• Reserve a position for the sanitary registration number during artwork design, avoiding remake and change procedures after certification.
• For products without secondary packaging, apply Article 7.1 and do not borrow the Article 7.2 list.
• Pre-clear all supplementary label and insert content against the three tests: truthful, verifiable and not misleading.

5. Verification checklist

• □ The ten items of secondary packaging have been checked one by one
• □ The six items of primary packaging have been checked one by one, where secondary packaging exists
• □ Instructions for use and warnings are in Spanish for imported products
• □ A position for the sanitary registration number has been reserved at both packaging levels
• □ The single-pack case has been handled under Article 7.1
• □ 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