Medical Device Definition under NT 37 Article 3.1 in Guatemala

1. Key takeaways

The definition of a medical device in Guatemala is set out in Article 3.1 of NT 37 Versión 5-2016: any instrument, apparatus or other similar or related article intended for human use, whether used alone or in combination, including its components, parts and accessories, proposed by the manufacturer for five categories of use — the diagnosis, prevention, monitoring, treatment or alleviation of disease; the diagnosis, prevention, monitoring, treatment, alleviation of or compensation for an injury or handicap; the investigation, replacement, modification or support of an anatomical structure or a physiological process; the diagnosis of pregnancy and the control of conception; and care during pregnancy, childbirth and the postnatal period, including care of the newborn. The decisive line that separates a device from a drug is whether the principal intended purpose is achieved by chemical action. This single test does more work in practice than the list of intended uses, because almost every borderline product — dressings, sutures, disinfectants, diagnostic reagents — is classified by asking where its primary mechanism of action sits. For manufacturers preparing a first submission, the definition is therefore not a formality but the foundation of the whole dossier: the classification report, the intended-use statements, the labelling and the family grouping all trace back to how Article 3.1 was read.

2. Legal basis

The definitional provisions and their companion rules are collected below, together with the statutory hook that makes registration mandatory. Read together, the four entries show how the standard expands outward from the core definition: the note to Article 3.1 polices the chemical-action boundary, Article 4 pulls dressings and surgical materials inside the perimeter, and Article 162 of the Health Code supplies the registration obligation that the whole framework serves.

3. Expert insights

Insight one: the definition includes the phrase proposed by the manufacturer (propuesta por el fabricante). This wording places the determination of intended use in the hands of the manufacturer through the labelling and instructions for use, and at the same time binds the responsibility to the manufacturer. If the instructions for the same hardware claim a pharmacological action, the product no longer follows the device route and must be registered as a drug — Article 3.1 of NT-37 expresses this by stating that devices which are attributed pharmacological properties by their composition shall be registered as pharmaceuticals. The wording therefore has two faces: it gives the manufacturer control over how the product is characterised, and it makes the manufacturer answerable if that characterisation is drawn to place the product outside the regime that its actual mechanism belongs to.

Insight two: absorbable sutures are an express exception written into the definition. The regulation allows products that biodegrade during use to remain within the device category. This carve-out shows that the authorities understand the boundary between biodegradation and chemical action, and companies should anchor their mechanism-of-action statements on precisely this point rather than making the vague claim that the product takes no part in metabolism. Drafting the mechanism section around the express exception gives the reviewer a text they can match against the note to Article 3.1, which shortens the qualification discussion considerably.

Insight three: Article 4 brings dressings and surgical materials into the device regime as a whole. This means low-value consumables such as gauze, bandages and adhesive plasters must go through sanitary registration instead of being imported as ordinary goods. The product example table in Annex 1 does indeed list dressings and bandages of various kinds, and the two provisions corroborate each other.

Insight four: components, parts and accessories are included together with the main unit. Because the definition expressly covers its components, parts and accessories, specialised accessories imported alongside the main equipment cannot be declared separately as non-devices, and the registration scope and the design of family grouping need to be planned with this in view from the outset. Leaving accessories out of the initial registration and trying to add them afterwards creates avoidable delay and inconsistency between the certificate and the goods presented at import.

4. Practical recommendations

• Record the qualification judgement in a written report, checking it clause by clause against the intended-use wording of 3.1.1–3.1.5, and do not infer it from the product category alone.
• Keep the intended-use language in the instructions for use and labelling consistent with the qualification report, and avoid any statement of pharmacological action.
• Where absorbable materials are involved, cite the exclusion wording of the note to Article 3.1 in the mechanism-of-action statement.
• Plan registration for dressing-type consumables as devices and do not import them as ordinary goods.
• List specialised accessories imported with the main unit within the same registration scope at the time of application, so that a supplementary registration is not needed later.

5. Verification checklist

• □ Checked the intended-use wording of NT-37 Articles 3.1.1–3.1.5 one by one
• □ Confirmed the product does not achieve its principal purpose by chemical action
• □ Checked whether the instructions for use contain any pharmacological claim
• □ Absorbable materials are covered by a citation of the exclusion wording
• □ Dressings and surgical materials are included in the registration planning
• □ Components, parts and accessories are all listed

Regulatory information verified as of 29 October 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