Three IVD Risk Categories under NT-40 in Guatemala

1. Key takeaways

In Guatemala, in vitro diagnostic reagents are classified into three tiers by sanitary risk (riesgo sanitario): Categoría I, low risk, covering culture media, staining materials, diluents, buffers and lysis solutions, and wash solutions; Categoría II, medium risk, covering molecular biology, endocrinology, toxicology and pharmacology, blood biochemistry, haematology, immunology, microbiology, faecal and parasitology testing, coagulation, blood gases, urine analysis, immunohaematology screening cells, and self-testing and self-monitoring assays; and Categoría III, high risk, covering donor and transplantation screening, immunological compatibility, and the diagnosis of highly communicable diseases including rapid tests. The legal basis is Article 3 of NT 40 Versión 3-2015, which lists 4 + 13 + 3 detailed entries across the three tiers. The tier assigned to a reagent drives the depth of the dossier and the attention the file will receive, so the classification exercise deserves the same rigour as the technical documentation itself, and it should be completed and recorded before the application form is drafted.

2. Legal basis

The classification scheme rests on the following provisions of NT 40 Versión 3-2015.

3. Expert insights

Insight one: the classification criterion is the impact of the result, not technical complexity. Article 3 states at the outset that the classification «se basa en el riesgo sanitario, teniendo en cuenta el conocimiento, entrenamiento, tecnología, análisis e impacto del resultado». Among these factors, the «impacto del resultado» — the impact of the result — is the core one. All three entries of Category III point to situations in which an incorrect result directly endangers other persons or public safety: an error in transfusion screening endangers the recipient of the blood, an error in transplantation matching endangers the recipient of the organ or tissue, and an error in communicable disease diagnosis endangers the public. A technically simple product can therefore sit in the highest tier, while a technically sophisticated product with no direct safety consequence sits lower.

Insight two: rapid tests are expressly pulled into Category III. Article 3.3.3 adds «incluyendo pruebas rápidas» — including rapid tests — immediately after the reference to the diagnosis of highly communicable diseases. This means that a product with a technologically simple format and a low operating threshold is still managed at the highest tier as long as its intended use falls within the diagnosis of those diseases. A lateral flow strip for such a target cannot be filed as Category I on the strength of its simple format; the use, not the form, decides the tier.

Insight three: Category II is the residual tier. Article 3.2 defines its scope as reagents that do not belong to Category I or Category III, and then lists thirteen fields. Those thirteen fields are an illustrative enumeration, not an exhaustive set of conditions. A reagent that appears nowhere in the enumerated list, yet also does not fall within Category I or Category III, lands in Category II. This residual construction makes the classification order of operations important: check the highest tier first, then the lowest, and only then apply the residual rule.

Insight four: the three reagent tiers do not intersect with the four device classes. Devices use Clase I to IV, determined by intended use crossed with sterility, while reagents use Categoría I to III, determined by sanitary risk. The two schemes use different words in the official texts and are judged on different axes. Mapping a reagent onto the device logic, for example by treating «Category I» as equivalent to an external, non-sterile Class I device, is a classic misclassification that can place a product in the wrong tier and distort the entire submission.

4. Practical recommendations

• Classify reagents under the three tiers of Article 3: first check whether the product hits one of the three Category III entries, then whether it falls within the four Category I entries, and assign everything else to Category II.
• Judge rapid test products by their intended use against Article 3.3.3, and never downgrade them by product format.
• Treat products outside the enumerated lists as Category II under the residual rule, and record the reasoning in the classification report.
• In the classification report, distinguish between the word Categoría for reagents and Clase for devices, and do not mix them.
• Keep the classification conclusion consistent across the application form, the labelling and the instructions for use.

5. Verification checklist

• □ The three Category III entries of Article 3.3 have been checked one by one
• □ The four Category I entries of Article 3.1 have been checked one by one
• □ Products matching neither have been assigned to Category II with the reasoning on record
• □ Rapid test products have been assessed by intended use rather than by format
• □ The classification report distinguishes Categoría from Clase
• □ The classification conclusion is consistent in all three places (application form, labelling, instructions for use)

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