Nine Additional Requirements for Other Devices: Article 6.3.2.5

1. Key takeaways

Article 6.3.2.5 of RTS 11.03.02:21 adds nine requirements for devices other than IVDs, medical IT systems and medical antiseptics or disinfectants, on top of the twelve general items: a) a description or diagram of the main components and accessories, where applicable; b) the insert, where applicable; c) the validation file supporting the shelf life of the device; d) the conditions for preservation, storage and transport; e) the qualitative and quantitative formulation, where applicable; f) the sterilisation certificate, where applicable; g) the GMP of the drug manufacturer, where applicable; h) the safety data sheet, where applicable; i) the clinical evaluation study. The total is twelve plus nine, that is twenty-one items.

This is the residual category, and it covers the great majority of ordinary devices, including many single-use consumables and surgical instruments. Because the list is residual, applicants often assume it is the lightest of the four; in reality three of its nine items carry no conditional wording, and one of those three is the item that takes longest to prepare.

The residual character also means that a product can be moved into this list by a decision taken elsewhere. A device that includes software but is not filed as a medical IT system, or a device that is not classified as an IVD, is assessed against these nine items rather than against the lists in articles 6.3.2.2 or 6.3.2.3. Confirming the classification first is therefore cheaper than confirming it after the dossier has been drafted.

• Nine additional documents apply to other devices, for a total of twenty-one items.
• Three items are unconditional: shelf-life validation, storage and transport conditions, clinical evaluation.
• Six items are conditional on the characteristics of the product.
• Clinical evaluation is mandatory here, unlike the equivalent item in the IT system list.
• The drug manufacturer GMP item identifies combination products with a medicinal component.
• Shelf-life validation determines whether the six-month import threshold can be met.

2. Legal basis

The residual list is anchored in article 6.3.2.5, with supporting provisions in the device definition, the import rules and the reference standards listed in the regulation. The table sets out each provision and the obligation it creates.

3. Expert insights

First insight: only three of the nine items lack the where applicable formula, and those three are the rigid core. Shelf-life validation under c, storage and transport conditions under d and clinical evaluation under i carry no waiver, while the remaining six, namely a, b, e, f, g and h, all end with cuando aplique. Splitting the list into a rigid group of three and a conditional group of six gives a fast test of whether a dossier is complete, and it also prevents over-investment in conditional documents that the product does not actually require. Reviewers tend to start with the rigid group, because those three items cannot be argued away by product characteristics.

Second insight: clinical evaluation under item i is mandatory for other devices, and this is the most commonly underestimated item. Compare article 6.3.2.3 g), where clinical evaluation for a medical IT system is qualified by where applicable, with article 6.3.2.5 i), which contains no such qualifier. Ordinary devices entering through the other-device route, including many single-use consumables and surgical instruments, must therefore supply a clinical evaluation study. The preparation period for this item is usually the longest in the entire dossier, because it depends on literature appraisal or on clinical data that the manufacturer may not yet hold in a form suitable for submission.

A clinical evaluation study also tends to expose gaps that are invisible in a specification. Where the clinical evidence is thin, the usual answer is a literature route built on an equivalence argument, which in turn requires technical, biological and clinical comparability to be shown rather than asserted. Starting that work at the dossier planning stage is what keeps the item from becoming the critical path at the end.

Third insight: the drug manufacturer GMP under item g is the identifier of a combination product. The item is written as BPM del fabricante del medicamento, the GMP of the manufacturer of the medicinal substance, and it corresponds to the combination product situation described in the final paragraph of article 3.14, where a device performs its function by pharmacological, immunological or metabolic means. Where the product contains a medicinal component, the file needs the GMP certificate of the drug manufacturer in addition to the device GMP certificate required by article 6.3.2.1 d). The two certificates cover different sites and cannot be interchanged.

Fourth insight: shelf-life validation under item c directly determines importability under article 6.4.1 c). Article 6.4.1 c) requires a remaining shelf life of not less than six months at the time of import. Where the validation under item c supports only a short shelf life, the product is systematically obstructed at the import stage regardless of how smoothly registration proceeded. For products labelled with no expiry date, as with some non-sterile instruments, the reasoning behind that determination should be stated in item c, so that the file is not assessed against a six-month threshold that does not fit the product.

4. Practical recommendations

• Split the nine items into the rigid three and the conditional six, and secure the rigid items first.
• Start the clinical evaluation study early, since it is mandatory under article 6.3.2.5 i) and has the longest lead time.
• For a combination product with a medicinal component, file the drug manufacturer GMP alongside the device GMP.
• Use shelf-life validation to support the six-month import threshold directly, and claim the longest demonstrable period.
• For a product without a stated shelf life, explain the basis for that determination in writing under item c.
• Assess each conditional document, including insert, formulation, sterilisation certificate and safety data sheet, against the actual characteristics of the product.

5. Verification checklist

• □ Rigid three items, namely shelf life, storage and transport, and clinical evaluation, satisfied
• □ Clinical evaluation study started early
• □ Drug manufacturer GMP filed separately for products with a medicinal component
• □ Shelf-life validation supports the six-month import threshold
• □ Basis for a no-expiry determination stated in writing
• □ Conditional documents assessed item by item

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 3.14, 6.3.2.5 a)–i), 6.3.2.3 g), 6.4.1 c) and 8.4.

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