Technical Literature, Catalogue and Package Insert Requirements

1. Key takeaways

Article 5.1.12 of NT 37 Versión 5-2016 lists “product technical literature, catalogue or package insert (in Spanish)” as a dossier item to be submitted when applicable. It is not mandatory for every project, but once submitted, or once used as a carrier of supplementary label information, it must satisfy the three constraints of the note to Article 7: truthful, verifiable and not misleading or confusing to the consumer. On the reagent side the corresponding provision is Article 4.1.6 of NT-40 — the package insert is a mandatory item, with no “when applicable” qualifier. This asymmetry between devices and reagents is one of the most commonly missed points when a team handles both product types in parallel, and it can leave a reagent dossier incomplete at the window even though the device track ran without a single omission. Planning the two sides against their own clause lists is the reliable way to keep both dossiers whole.

• For devices, the insert is an optional item governed by the “when applicable” qualifier.
• For reagents under NT-40 Article 4.1.6, the Spanish-language insert is mandatory.
• The applicability judgment for devices should ask whether the product can be used safely without the insert.
• The insert is subject to the three constraints of the note to Article 7.
• The reagent insert must cover instructions for use, storage, components, precautions and safe correct use.
• Use language must be consistent across the insert, the product description and the packaging.

2. Legal basis

The table below collects the provisions that define when an insert is filed, what it must contain on the reagent side, and the constraints that govern its content on both sides. It serves as the drafting brief for whoever writes or translates the insert.

3. Expert insights

Insight one: for devices the insert is conditional, for reagents it is mandatory. Article 5.1.12 carries “cuando aplique”, while NT-40 Article 4.1.6 does not. The difference reflects how dependent each product type is on its instructions: reagent use depends heavily on the insert — Article 2.4 defines it as the whole of the information needed for safe and correct use — whereas devices can convey part of their information through the label alone. Processing reagents with the device standard of care will drop a mandatory item, and the omission is visible the moment the checklist is run against the reagent list of NT-40.

Insight two: the “when applicable” judgment for devices tracks product complexity. Devices that require professional handling, have multiple accessories or follow a specific usage sequence are practically impossible to use safely without an insert; extremely simple products such as basic dressings can convey everything on the label. The test should be whether the product can be used safely if the insert is absent — not whether an insert happens to exist already. Framing the decision this way produces a defensible record either way, and it prevents the two opposite errors of reflexively omitting the insert or filing one for every product regardless of need.

Insight three: the insert is also a compliance risk surface. The three constraints of the note to Article 7 — truthful, verifiable and not misleading — apply directly to insert content. Indications beyond the registered scope, unverified performance data or parameters inconsistent with the finished product specifications all convert the insert from a dossier document into evidence of a violation. Because the insert travels with the product and reaches the end user, its wording is as much a regulatory commitment as the specifications themselves, and it deserves the same level of controlled drafting and review.

Insight four: the insert and the product description of Article 5.1.4 corroborate each other. When the reviewer judges intended use and classification, the product description, the packaging and the insert are read together. If the use statements across the three are inconsistent, the discrepancy can trigger reclassification or even refusal of registration under Article 10.4. Consistency checks across the three documents should therefore be built into the final review of the dossier, not left to chance after each document has been approved in isolation.

4. Practical recommendations

• Judge whether a device needs an insert by asking whether it can be used safely without one, and do not omit it by default.
• Always prepare a Spanish-language insert for reagents, covering use, storage, components and precautions as Article 2.4 requires.
• Localise the instructions for use and warnings of imported devices within the insert while simultaneously satisfying Article 7.1.2.
• Pre-clear insert content against the three constraints and cross-check it against the specification parameters of Article 5.1.3.
• Keep the use statements identical across the insert, the product description and the packaging.

5. Verification checklist

• □ The need to submit an insert has been judged for the device
• □ A Spanish-language insert has been prepared for reagents
• □ The insert covers the content required by Article 2.4
• □ Instructions for use and warnings of imported devices have been localised
• □ Insert content has been pre-cleared against the three constraints
• □ Use statements are consistent across insert, product description and packaging

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