Six Additional Requirements for IVDs: Article 6.3.2.2

1. Key takeaways

Article 6.3.2.2 of RTS 11.03.02:21 adds six requirements for in vitro diagnostic devices (agentes de diagnóstico in vitro) on top of the twelve general items. The six are: a) the insert; b) the technical file supporting the shelf life or the stability of the product; c) the conditions for preservation, storage and transport; d) the qualitative and quantitative formulation expressed in units of measure, dosage, percentage or composition; e) the safety data sheet (ficha de seguridad); f) the validation report of the test, the assay or the product.

Because the article opens with the formula used throughout the regulation, meaning in addition to the requirements of article 6.3.2.1, the two lists are cumulative. An IVD dossier therefore contains twelve plus six, that is eighteen items, and the six additional documents are not an alternative route for diagnostic products but a supplement to the general file.

The six items also follow the reagent through its lifecycle rather than around its specification. The insert describes how the product is used, the stability file proves how long it remains usable, the storage and transport conditions state how it must be kept in the meantime, the formulation identifies what it contains, the safety data sheet describes the hazards of those contents, and the validation report demonstrates that the test performs as claimed. Read in that order, the six items form a coherent narrative that a reviewer can follow from the bench to the shelf.

• Six additional documents apply to every IVD, bringing the dossier to eighteen items.
• The insert must accompany the product and follow the applicable label fields.
• Stability and shelf-life data are a filing requirement, not only an internal study.
• Storage and transport conditions must be stated explicitly.
• The formulation must be expressed in units, dosage, percentage or composition.
• A validation report covering the test, the assay or the product is mandatory.

2. Legal basis

The additional IVD items sit in article 6.3.2.2 and interact with the labelling rules in article 6.3.4 d) and with the import threshold in article 6.4.1 c). The table records each provision and the practical consequence it carries for a diagnostic dossier.

3. Expert insights

First insight: the IVD additions focus on reagent characteristics rather than instrument characteristics. Among the six, stability under item b, storage and transport under item c, formulation under item d and the safety data sheet under item e are concerns specific to reagent products. Compared with article 6.3.2.3, which adds seven items for medical IT systems and asks about component diagrams, design and cybersecurity reports and version history, the difference between the two lists marks the division between reagents and software or systems in terms of review emphasis. An IVD that includes an instrument therefore needs to be examined against both lists before the index is fixed.

Second insight: the registration number field may move to the secondary packaging, which is a practical convenience for IVDs. Article 6.3.4 d), item 1 provides that the primary packaging should carry the registration number field, or otherwise the secondary packaging should carry it, as in the case of IVD reagents. Where the vial surface leaves little room, the registration number may therefore be printed only on the box. The declaration of in vitro diagnostic use or IVD under article 6.3.4 d), item 15, however, remains a mandatory element of the primary packaging and cannot be moved or omitted.

Third insight: the validation report under item f is the core of IVD review. The wording of the provision is informes de validación de la prueba, ensayo o del producto, listing the test, the assay and the product side by side. For an IVD this means analytical performance, covering precision, accuracy, limit of detection and linearity, together with clinical performance. This is a different level of requirement from the clinical evaluation study mentioned in article 6.3.2.5 i), and the two should not be treated as substitutes for one another.

A validation report that covers only analytical performance leaves the clinical claim on the label unsupported, while a report that covers only clinical performance leaves the laboratory unable to judge whether the assay behaves consistently between runs and between lots. Presenting both levels in one report, with the study design, the acceptance criteria and the results set out before the conclusion, is what allows the reviewer to see that the claim and the evidence were matched by design rather than joined afterwards.

Fourth insight: stability data determine whether the shelf-life threshold at import can be met. Article 6.4.1 c) requires that a device have a remaining shelf life of not less than six months at the time of import. IVD reagents commonly carry short expiry dates, so a stability package that supports only a shelf life within six months will block the product at the border even after approval. The stability file under item b is therefore not merely a registration document; it is a precondition of importability, and it should be designed with the distribution chain in mind rather than only with the registration file in mind.

4. Practical recommendations

• Build the IVD index on twelve plus six, that is eighteen items, and do not lose the additional list when the general list is complete.
• Write the insert in Spanish and cover the fields applicable under article 6.3.4 d).
• Move the registration number to the secondary packaging where space requires it, but keep the IVD declaration on the primary packaging.
• Cover both analytical performance and clinical performance in the validation report.
• Ensure stability data support a remaining shelf life of not less than six months at import.
• State the formulation by unit of measure, dosage, percentage or composition, and keep it consistent with the safety data sheet.

5. Verification checklist

• □ IVD dossier complete at eighteen items
• □ Insert in Spanish with all fields present
• □ IVD declaration printed on the primary packaging
• □ Validation report covers analytical and clinical levels
• □ Stability data support more than six months of remaining shelf life
• □ Formulation consistent with the safety data sheet

The regulations cited in this article are RTS 11.03.02:21, Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), articles 6.3.2.2 a)–f), 6.3.4 d) items 1 and 15, and 6.4.1 c).

Regulatory information verified as at 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Salvadoran market. Our team manages Ministry of Health (MINSAL) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com