El Salvador Medical Device Legal Framework: Four Layers of Law

1. Key takeaways

The legal sources for devices in El Salvador divide into four layers. Layer one is the medicines law, the Ley de Medicamentos (Decreto Legislativo No. 1008, 2012-03-02), together with its general regulation (Decreto Ejecutivo No. 245, 2012-12-20). Layer two is the institutional law, Decreto Legislativo No. 891 of 2023-12-04. Layer three consists of three Salvadoran technical regulations: RTS 11.03.02:21 as the main rule, RTS 11.03.03:22 on manufacturing practice and RTS 11.03.04:23 on technovigilance. Layer four is the SRS tariff schedule and its reliance policy. RTS 11.03.02:21 is the governing text for registration, while the other three layers answer three separate questions: where the power comes from, who exercises it, and how much is paid and whether evidence can be reused.

Reading the framework as a single statute is the most common analytical error. Each layer has its own issuing procedure, its own amendment cycle and its own publication record, so a citation that is correct today can be overtaken by a tariff revision or a policy version without any change to the technical regulation itself.

• The base is a medicines law, not a stand-alone medical device law.
• The institutional layer changed the executing body while the technical text still names the DNM.
• Three technical regulations apply cumulatively, not as alternatives: conduct, quality system and post-market vigilance.
• The 2025 tariff and the reliance policy are administration-level instruments and move faster than the RTS.
• Fees are quoted in US dollars, the lawful currency of El Salvador, and are exempt from IVA.

2. Legal basis

The four layers are published in different instruments and at different times. The table below records each one with its reference, publication data and the provision through which it enters a device file.

3. Expert insights

Insight one: the base is a medicines law, not a dedicated device law. El Salvador has no separate medical device statute, and device regulation hangs beneath the medicines law. That explains why so many terms in RTS 11.03.02:21, such as registration holder, responsible professional and establishment authorisation, are borrowed from the medicines system. For an applicant the practical effect is that the general procedural requirements of the medicines law apply as a fallback: where the RTS is silent, there is not an absence of rules but a return to the medicines law and its general regulation. A dossier that satisfies the RTS yet ignores the parent law is therefore only half compliant.

Insight two: the official text contains a numbering slip that matters when citing. Article 7.3 of RTS 11.03.02:21 cites the general regulation of the medicines law as “Decreto Legislativo No 245”, whereas the formal reference of that instrument is Decreto Ejecutivo No. 245, an executive decree rather than a legislative one. The error is a defect in the official text and does not affect validity, but citations in a file should follow the formal reference so that a reviewer has no reason to query the source. The same discipline applies to every cross-reference copied forward into a cover letter.

Insight three: the three technical regulations divide the field into conduct, system and aftermath. RTS 11.03.02:21 governs registration and circulation, RTS 11.03.03:22 governs the manufacturing quality system, and RTS 11.03.04:23 governs post-market vigilance. These are not three parallel options but three sets of obligations that one company carries at the same time: an importer needs an establishment authorisation under Article 6.2 of RTS 11.03.02:21, the establishment needs a quality system under RTS 11.03.03:22, and it also needs a vigilance contact under RTS 11.03.04:23. Missing any one of the three leaves the other two unable to carry the product to market.

Insight four: the tariff and the reliance policy are the new variables of 2025. The 2025 edition of the tariff was issued by the Consejo de la SRS, and its Article 5 states that matters not provided for in the schedule remain subject to the special price law for DNM services. The practical reading is that the basis can run on two tracks, and the operative figure is the current payment instruction (mandamiento de pago) issued by the SRS rather than any historical table. Budgets built from a previous schedule, or from a third-party quotation, should be treated as a practical estimate only.

4. Practical recommendations

• Write the four layers into the internal manual and mark the first page of every file with the basis relied on: RTS 11.03.02:21 (Acuerdo No. 14-2022), the medicines law (DL No. 1008) and the general regulation (DE No. 245).
• Cite the general regulation consistently as Decreto Ejecutivo No. 245, keeping the slip in Article 7.3 of the RTS clearly distinguished in internal notes.
• Keep a separate obligation register for each of the three technical regulations, covering circulation, quality system and vigilance, rather than merging them into a single table.
• Treat official fees as the current SRS payment instruction, using historical tables and third-party quotations for estimation only.
• Where reliance is claimed, cite the policy version 01.01.02.POL.20250508.01 in the application so the reviewer can locate the basis.
• Review the NORMATIVAS and LISTADOS sections of the SRS website every quarter, since both the technical regulations and the tariff can be updated on a rolling basis.

5. Verification checklist

• □ The first page of the file lists the four layers and their references
• □ The general regulation is cited as Decreto Ejecutivo No. 245
• □ Separate obligation registers exist for the three technical regulations
• □ The fee basis has been confirmed against the current SRS payment instruction
• □ The reliance application states the policy version number
• □ A quarterly review reminder for the SRS website is in place

Instruments cited: Ley de Medicamentos (Decreto Legislativo No. 1008, Diario Oficial No. 43, Tomo No. 394, 2012-03-02); Reglamento General de la Ley de Medicamentos (Decreto Ejecutivo No. 245, Diario Oficial No. 239, Tomo No. 397, 2012-12-20); Ley de la Superintendencia de Regulación Sanitaria (Decreto Legislativo No. 891, Diario Oficial No. 227, Tomo No. 441, 2023-12-04); RTS 11.03.02:21 (Acuerdo No. 14-2022, Diario Oficial No. 156, Tomo No. 436, 2022-08-23), Articles 7.2 and 7.3; RTS 11.03.03:22 (Acuerdo No. 13-2022, same journal); RTS 11.03.04:23 (Acuerdo No. DN.05.2024, Diario Oficial No. 68, Tomo No. 443, 2024-04-12); Tarifario de la SRS, 2025 edition; Política de Aplicación de Reliance (01.01.02.POL.20250508.01, Version No. 01, SRS website, 2025-05-08).

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