The Twelve General Dossier Requirements: Article 6.3.2.1 Explained

1. Key takeaways

Article 6.3.2.1 of RTS 11.03.02:21 sets out the twelve general requirements, lettered a to l, that form the documentary base of every device registration dossier in El Salvador. The list is drafted as a closed set: a) the number of a paid payment order; b) the device registration form; c) the free sale certificate (CVL); d) the GMP certificate; e) the quality control specification applicable to the device; f) the manufacturing or maquila contract, where applicable; g) the device technical datasheet; h) the device technical information; i) a mock-up of the primary packaging label; j) a mock-up of the secondary packaging label; k) the risk management report; l) the safety and health alert report.

Two structural features matter from the first reading. The payment receipt appears as item a, ahead of every technical document, which places payment before any examination of content. The closing paragraph of the same article then adds a condition that covers the dossier as a whole: every official or legal document issued abroad must be legalised in accordance with national rules.

• a) Number of the paid payment order (número de mandamiento de pago cancelado), the proof that the fee has already been settled.
• b) Device registration form, the structured data sheet that identifies the product, the manufacturer and the representative.
• c) Free sale certificate (Certificado de Venta Libre, CVL), issued by the authority of the country of origin.
• d) GMP certificate (BPM certificate), confirming that the manufacturing site works to good manufacturing practice.
• e) Quality control specification applicable to the device, the benchmark used later for laboratory testing.
• f) Manufacturing or maquila contract, required only where the device is produced by a third party.
• g) Device technical datasheet (ficha técnica), the standardised summary of the product.
• h) Device technical information (información técnica), the supporting evidence behind the summary.
• i) Mock-up of the primary packaging label (proyecto de etiqueta), one separate artwork.
• j) Mock-up of the secondary packaging label, a second separate artwork.
• k) Risk management report, covering identification, evaluation, control and monitoring of risk.
• l) Safety and health alert report, disclosing the product safety record and any existing alert.

2. Legal basis

The twelve items sit in a technical regulation issued by the Salvadoran health regulator and are complemented by four incremental lists and by the current fee schedule. The table below records the instruments, their references and the provisions that carry each requirement, so that a dossier can be mapped provision by provision.

3. Expert insights

First insight: the twelve items are a baseline, and the four category lists are increments. Article 6.3.2.1 is followed by article 6.3.2.2, which adds six items for IVDs, article 6.3.2.3, which adds seven items for medical IT systems, article 6.3.2.4, which adds nine items for medical antiseptics and disinfectants, and article 6.3.2.5, which adds nine items for other devices. Each of these provisions opens with the phrase además de los requisitos en el numeral 6.3.2.1, meaning in addition to the requirements of article 6.3.2.1. An IVD dossier is therefore twelve plus six, that is eighteen items, and not a choice between two alternative sets. Reading the articles as alternatives is one of the most common planning errors, because the incremental list is short and easy to overlook when the twelve-item baseline looks complete.

Second insight: item a places payment inside the document list, which makes payment a condition of acceptance. Article 6.3.2.1 a) asks for the number of a payment order that has been paid, not a promise to pay. Read together with article 4 of the fee schedule, under which a payment remains valid for twelve months, the interval between settlement and submission has to stay inside one year, and the payment number has to be entered in the application form. A dossier filed with an expired payment number fails at the counter, before any reviewer looks at the technical content.

Third insight: items i and j ask for artwork, not for a written description of the label design. The provision uses the term proyecto de etiqueta, a mock-up or draft artwork, and it requires one for the primary packaging and a second for the secondary packaging. Read with the field lists in article 6.3.4 d) and e), the primary packaging carries sixteen fields, while the secondary packaging takes fields 2, 3, 6 to 12 and 15 from that list and adds the pack content. A mock-up that omits fields, or that shows them only in a written table, does not satisfy the requirement, because the reviewer is checking whether the printed artwork can physically display every mandatory field.

Fourth insight: items k and l move risk management and vigilance forward to the pre-market stage. The risk management report required by article 6.3.2.1 k) corresponds to the principle in article 5.2.1 b). The safety and health alert report required by item l) obliges the applicant to state the safety situation of the product and any existing alert at the moment of filing. This forms a complete causal chain with article 6.3.6 a), under which a product subject to an international health alert is not approved: the applicant must declare at filing, and concealment becomes a ground for refusal rather than a matter discovered later.

4. Practical recommendations

• Build the dossier index on the baseline plus increment logic: eighteen items for an IVD, nineteen for a medical IT system, twenty-one for an antiseptic or disinfectant and twenty-one for other devices.
• Pay the fee and obtain the payment number before submission, and place the twelve-month validity of that payment into the project schedule.
• Prepare label artwork against the field lists in article 6.3.4 d) and e), with one artwork for primary packaging and one for secondary packaging.
• Declare existing alerts truthfully in the safety and health alert report instead of relying on the hope that they will not be found.
• Complete legalisation of foreign documents before submission, so that the file is not returned during acceptance review.
• Keep the technical datasheet and the technical information as separate documents: the first is a specification summary, the second is the supporting technical argument.

5. Verification checklist

• □ Dossier index built on baseline plus increments
• □ Payment number obtained and still inside its twelve-month validity
• □ Primary and secondary packaging label artwork both complete
• □ Safety and health alert report truthfully completed
• □ Foreign documents legalised
• □ Technical datasheet and technical information prepared separately

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 6.3.2.1 to 6.3.2.5, 6.3.4 d) and e), 6.3.6 a) and 5.2.1 b); and the Tarifario de la Superintendencia de Regulación Sanitaria (2025 edition, published on the SRS website in 2025-10), articles 3.1.1 and 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