IVD-Specific Documentation Requirements

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, spreads the documentation requirements for in vitro diagnostic devices (IVDs) across three places: Article 32, item 6 (at the risk classification stage) requires six items — the technical datasheet (ficha técnica), the insert (inserto), storage conditions, storage and transport conditions, the safety data sheet (hoja de seguridad), and the qualitative and quantitative formulation expressed in measurement units, percentages or ingredients, with CAS numbers; Article 43, Section 2 (at the registration stage) requires six items — technical datasheet, insert, technical documentation supporting shelf life or stability, storage and transport conditions, safety data sheet, and qualitative and quantitative formulation (by measurement unit, dosage, percentage or ingredient); and Article 44, item 3 (from Class IIA) adds the validation report of the test, assay or product. The GRZAN regulatory team notes: the IVD lists at the classification and registration stages are not identical — the registration stage adds the stability document; as a practical estimate, prepare the full set once to the registration standard and reuse it at classification, saving one round of supplements.

2. Legal basis

The table below maps each IVD requirement to its provision and key point.

3. Expert insights

Insight 1: the two lists differ by exactly one item — the stability document. Article 32, item 6 (classification), lists condiciones de conservación and almacenamiento y transporte side by side; Article 43, Section 2 (registration), replaces the former with documento técnico que respalde la vida útil o estabilidad. In other words, the registration stage demands evidence of stability, not merely a statement of storage conditions. Preparing the full set once to the registration standard is the simplest approach.

Insight 2: the safety data sheet maps to chemical management, not clinical evidence. Article 32, item 6 e), and Article 43, Section 2 e), both require the hoja de seguridad (safety data sheet, SDS). For IVDs containing chemical reagents, this document is the basis for transport, storage and emergency handling, and it sits on the same logical chain as Article 18, which requires a separate transport licence for IVDs needing special transport conditions.

Insight 3: the validation report is added from Class IIA. Article 44, item 3, requires IVDs to submit informes para la validación de la prueba, ensayo o del producto — reports for the validation of the test, assay or product. This is an important dividing line: Class I IVDs need no validation report; Class IIA and above do. When planning IVD products, classify under Article 29 first, then decide whether validation studies are needed.

Insight 4: the IVD qualitative and quantitative formulation must carry CAS numbers. Article 32, item 6 f), requires the formulation con su número CAS — with its CAS number — echoing the CAS number field in Article 32, item 1 o). For multi-component reagents this means a CAS number for every chemical component, not only the main ingredient.

Insight 5: the primary label must carry a dedicated IVD use statement. Article 84, Section 1 o), requires the IVD primary label to include the declaración de uso de diagnóstico in vitro o IVD. This is a mandatory label field triggered by the product category, operating in the same way as the sterile symbol triggering ISO documentation (Article 43, item 13): whatever appears on the label must have a corresponding supporting document or statement.

4. Practical recommendations

• Prepare the IVD set once to the six-item registration standard and reuse it at the classification stage.
• Prepare stability evidence as a formal technical document, not merely a statement of storage conditions.
• For IVDs containing chemical reagents, complete the safety data sheet in step with the transport licence application.
• Schedule validation studies early for Class IIA and above; do not schedule them for Class I.
• Provide a CAS number for every component of multi-component reagents, not only the main ingredient.
• Add the IVD use statement field to the primary label and update the insert at the same time.

5. Verification checklist

• □ The IVD documentation set is complete once, to the six-item registration standard
• □ Stability evidence has been prepared as a formal technical document
• □ IVDs containing chemical reagents have a safety data sheet in place
• □ Validation studies are scheduled by class (from IIA)
• □ CAS numbers are provided for every component of multi-component reagents
• □ The primary label includes the IVD use statement field

Related reading: [Article 21 — The sixteen Class I dossier items](/honduras-medical-device-registration/class-i-dossier-sixteen-requirements/) | [Article 22 — What Class IIA adds](/honduras-medical-device-registration/class-iia-iso-13485-and-software/) | [Article 34 — The transport licence](/honduras-medical-device-registration/transport-licence-article-18/)

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 Honduran market. Our team manages Secretariat of Health (SESAL) registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com