SRS Regulatory Translation Requirements: The Complete Guide for Drugs and Medical Devices in El Salvador

El Salvador is the only regulator in LATAM's core seven where the authority itself was replaced during the current filing cycle — the Superintendencia de Regulación Sanitaria (SRS) legally succeeded the Dirección Nacional de Medicamentos (DNM) on 7 August 2024 under Legislative Decree No. 891 and its June 2024 reforms, absorbing DNM's competencies plus registration functions previously exercised by the Ministerio de Salud, the Ministerio de Agricultura y Ganadería, and the Consejo Superior de Salud Pública (CSSP) (SRS Ley; Asamblea Legislativa). Every technical regulation — the Ley de Medicamentos (Decreto Legislativo No. 1008), the RTCA harmonized instruments, and the RTS 11.03.02:21 for medical devices — remains in force, but the authority receiving the dossier, signing resolutions, and running inspections is now the SRS. Existing DNM sanitary registrations remain valid; new filings, renewals, and clinical-trial submissions are decided by the SRS (LatinAlliance).

The second structural fact: El Salvador operates inside the Central American harmonized framework (RTCA), so a compliant El Salvador drug dossier is largely reusable in Guatemala, Honduras, Nicaragua, Costa Rica, and Panama through Mutual Recognition under RTCA 11.03.59:18 Anexo 2 (SRS RTCA). Its official-language footprint is also the narrowest in the region: castellano is mandatory only for device labelling, IFU/manuals of used or refurbished biomedical equipment, and clinical-trial protocols/ICFs; the ethics-committee manual (CNEIS) permits the original investigator's brochure in its source language with a Spanish summary, and the pharmaceutical registration guide reserves traducción oficial (sworn translation) for legal-administrative documents — Carta de Representación, apostilles, powers of attorney, foreign certificates of pharmaceutical product — not for technical evidence (Manual CNEIS; RTS 11.03.02:21).

For a Miami-based sponsor, El Salvador is best understood as a transition-risk jurisdiction stacked on top of a regional-recognition jurisdiction. Amavita's 7th QC gate — Document Currency carries dual weight here: the underlying foreign document must be current and it must be prepared for either the DNM legacy expedient or the SRS successor expedient — and increasingly, for onward mutual-recognition filings in Guatemala, Honduras, or Nicaragua.

Name: Superintendencia de Regulación Sanitaria (Superintendency of Health Regulation), SRS — successor authority to the Dirección Nacional de Medicamentos (DNM). The SRS is an autonomous public-law institution with technical character, its own legal personality and patrimony, and full financial, administrative, and budgetary autonomy (SRS Ley Art. 1).

Establishing statute: Ley de la Superintendencia de Regulación Sanitaria, Legislative Decree No. 891 of 30 November 2023, reformed by Legislative Decree No. 30 of 19 June 2024 (published in the Diario Oficial No. 129, Tomo 444, on 8 July 2024). The Ley entered into force on 7 August 2024. Article 39-A grants a 120-business-day dissolution period for the DNM to ensure uninterrupted continuity of pending files (SRS Ley Arts. 1, 3, 39-A, 46; LatinAlliance). The underlying substantive statute — the Ley de Medicamentos, Decreto Legislativo No. 1008 of 22 February 2012 (Diario Oficial No. 43, Tomo No. 394, 2 March 2012) — and its General Regulation (Decreto Legislativo No. 245, Diario Oficial No. 239, Tomo No. 397, 20 December 2012) remain the operative technical laws for medicines and medical devices (Ley de Medicamentos; RTS 11.03.02:21 §§7.2–7.3).

Scope: The SRS is the State authority responsible for regulating, monitoring and granting sanitary registration, registration recognition, marketing authorization and their modifications and renewals, and import, export and certification permits for pharmaceutical products, medicines, nutritional supplements, medical devices and equipment, other health technologies, cosmetics, hygienics, chemicals, foods, beverages, alcohol, tobacco, nicotine-release devices, and related products for human and veterinary use (SRS Ley Art. 3).

Website: https://www.srs.gob.sv

Headquarters address: Blv. Merliot y Av. Jayaque, Edif. SRS, Urb. Jardines del Volcán, Santa Tecla, La Libertad Sur, La Libertad. Phone: (+503) 2522-5000 (SRS).

Current head of authority: Superintendente de Regulación Sanitaria — MSc. Noé Geovanni García Iraheta (appointed 31 January 2025) (Portal de Transparencia).

Adjacent bodies sharing responsibility. El Salvador's post-August-2024 architecture is intentionally centralized in the SRS. Two adjacent bodies retain jurisdiction over clinical research.

El Salvador's rule is the most surgically narrow of the Big 7 on Spanish translation of technical documents, and the most expansive on Spanish-language labelling and IFU.

Statutory anchor — RTS 11.03.02:21 §6.3.4.d (verbatim, medical devices):

"El etiquetado del empaque primario debe presentarse en idioma castellano o mediante simbología conforme a la norma ISO 15223-1, en su versión vigente."

The primary-package label must be in castellano or via ISO 15223-1 symbology, in its current version (RTS 11.03.02:21 §6.3.4.d).

Statutory anchor — RTS 11.03.02:21 §6.4.3.e (verbatim, used biomedical equipment):

"El fabricante debe suministrar al usuario los manuales de operación, instalación y mantenimiento en el idioma de origen y en castellano."

For used, remanufactured, or reconditioned biomedical equipment, the manufacturer must supply operation, installation, and maintenance manuals in both the source language and castellano (RTS 11.03.02:21 §6.4.3.e).

Statutory anchor — Manual CNEIS (verbatim, clinical trials):

"Si el original está escrito en otro idioma: debe presentarse el protocolo traducido al español; la versión en español debe incluir la fecha de edición; deben entregarse tres copias impresas y una copia electrónica de la versión en español."

Foreign-language protocols must be filed with a complete Spanish translation, three printed copies, one electronic copy, and the Spanish version must carry its own edition date (Manual CNEIS).

Two doctrinal facts embedded in the framework. First, castellano is a labelling and IFU rule, not a general dossier translation rule. RTS 11.03.02:21 explicitly does not state that all foreign technical documents in a medical-device registration dossier must be translated to Spanish, and the RTS on pharmacovigilance (RTS 11.02.02:16) is silent on any general Spanish-translation obligation (RTS 11.02.02:16 §§100–104). Second, for clinical trials, the ethics committee (CNEIS) applies a bifurcated rule: the investigator's brochure can remain in its original language accompanied by a Spanish summary, but the protocol and the ICF must be fully translated to Spanish and adapted to the reading level of the subject population — not literally translated (Manual CNEIS).

Drug labelling — RTCA 11.01.02:04 (verbatim requirement). The Central American Technical Regulation on drug labelling — RTCA 11.01.02:04 (Resolution 275-2011 COMIECO-LXI, modified by Resolution 340-2014) — governs labelling of pharmaceutical products marketed in El Salvador. Labelling must be in castellano; imported products' labels may include the source language in addition to castellano, but the Spanish text is the reference version for inspection and enforcement (SRS RTCA; Resolución 166-2006 modificatoria).

Drug registration dossier — RTCA 11.03.59:18. The Central American Technical Regulation Productos Farmacéuticos. Medicamentos para Uso Humano. Requisitos de Registro Sanitario (Resolution 446-2021 COMIECO-XCIV of 14 June 2021, in force) governs the sanitary-registration dossier composition and Mutual Recognition procedures across the six Central American member states. It is the substantive dossier standard applied by the SRS (SRS RTCA; Lexology summary).

Clinical-trial language table (medical devices — RTS 11.03.02:21 §§6.1–6.3.4; drugs — Manual CNEIS + Ley de Medicamentos Art. 66).

The regime is layered by document type, not by document age. Unlike Peru (two-year currency rule) or Colombia (INVIMA one-year rule for CFS), El Salvador's technical regulations do not impose a fixed calendar-day currency limit — but Salvadoran practice requires the underlying Certificate of Free Sale, CPP, and GMP certificate to be current and free of alerts, and the SRS may reject stale filings under Ley de Medicamentos general provisions on sanitary safety (RTS 11.03.02:21 §6.4.1).

*El Salvador reserves traducción oficial — sworn translation — for legal-administrative instruments, not technical evidence. The pharmaceutical registration guide C02-RS-01-UR_PF.GUI01 v06 (published by the DNM and inherited by the SRS Unidad de Registro de Productos Farmacéuticos) states in §5 that traducción oficial* is reserved for documents such as the Carta de Representación, apostilles, and foreign certificates of authority. Technical documents (clinical evaluation reports, risk-management reports, stability studies, validation reports) do not require sworn translation, though many are subject to castellano-labelling or IFU obligations under RTS 11.03.02:21 (DNM Guide C02-RS-01-UR_PF.GUI01 v06 §5).

Tier table.

Apostille sequencing. El Salvador acceded to the Hague Apostille Convention. Documents issued in a Hague-Convention country must be apostilled by that country's competent authority before entering El Salvador; documents from non-Hague countries require auténtica through El Salvador's diplomatic and consular representations (RREE). Salvadoran documents destined for foreign use are apostilled free of charge by the Ministerio de Relaciones Exteriores — the sole issuing authority — and take immediate effect in any Hague-Convention country without further consular processing (RREE).

The sequencing rule that trips foreign sponsors: the foreign document must be apostilled in its country of origin, then translated in El Salvador by an authorized official translator. Translating first and then apostilling the translation does not create an apostilled foreign document — it creates an apostilled Salvadoran translation, and the underlying foreign public document remains unauthenticated. Sponsors filing in El Salvador must apostille first, translate second, and file both together.

Amavita's 7th QC gate — Document Currency. El Salvador is the LATAM jurisdiction where currency risk is most operationally unpredictable, because two structural facts stack on top of each other. First, the SRS is still consolidating DNM legacy files under a 120-business-day dissolution rule (LatinAlliance) — an apostille or CFS obtained during the transition may face jurisdictional questions if presented to the successor unit. Second, RTS 11.03.02:21 does not specify calendar-day review timelines, meaning a dossier can sit in queue while its underlying foreign documents age. Amavita's Document Currency gate captures both: it timestamps every foreign document at apostille, at translation, and at filing, and re-issues a fresh translation within 48 hours if the sponsor's apostilled document is refreshed under the First-Pass Acceptance Program.

A preclinical package for a single drug or device program routinely runs 800–3,500 pages: pharmacology, PK/ADME, toxicology, safety pharmacology, biocompatibility (for devices), and their appendices. El Salvador operates within the Central American RTCA harmonized regime (RTCA 11.03.59:18 for drugs, RTCA 11.03.63:19 device references), and its language surface is the narrowest in LATAM — castellano is mandatory only for device labels (RTS 11.03.02:21 §6.3.4.d — or ISO 15223-1 symbology), used biomedical equipment IFU (§6.4.3.e), and clinical-trial protocols/ICFs (Manual CNEIS). The rest of the preclinical stack has significant flexibility.

D.1 Do we have to translate every page of the preclinical stack?

No. SRS/DNM's Amavita-verified position:

• Drugs under RTCA 11.03.59:18: Central American harmonized regime with Anexo 2 Mutual Recognition across Guatemala, Honduras, Nicaragua, Costa Rica, and Panama — a compliant SRS drug dossier becomes a regional launchpad. Preclinical modules follow CTD structure; Spanish is preferred but reviewers accept English technical annexes at the SRS level, with Spanish executive summaries.
• Devices under RTS 11.03.02:21: §6.3.4.d permits castellano OR ISO 15223-1 symbology on medical-device primary labels. §6.4.3.e requires bilingual manuals only for used biomedical equipment IFU. Sponsor-generated preclinical (biocompatibility, sterility, stability, risk analysis, electrical safety) is treated as technical documentation, not as traducción oficial-scoped material.
• Traducción oficial is reserved for legal-administrative documents under DNM Guide C02-RS-01-UR_PF.GUI01 v06 §5 — not for study-report bodies.
• Clinical trials under Manual CNEIS: Spanish protocol/ICF is mandatory; investigator's brochure accepted in source language with a Spanish summary.
• PAHO Level IV reliance: RTS §6.1.4(a) allows recognition of decisions from PAHO/WHO Level IV-certified agencies and high-surveillance agencies — the substrate for accepting foreign preclinical review letters with reduced translation burden.

D.2 If translation IS required — is it text-only or does it require desktop publishing (DTP)?

D.3 If translation is NOT required — what substitutes for it?

El Salvador's answer is the most flexible in the region for device preclinical because of the ISO 15223-1 symbology substitution at §6.3.4.d. Amavita's recommended format:

For drugs (RTCA 11.03.59:18 regional dossier):

1. Original English CTD Modules 3, 4, and 5 — accepted at SRS technical tier for the initial dossier body.
2. Full Spanish CTD Module 2 (Quality Overall Summary, Non-clinical Overview 2.4, Non-clinical Written & Tabulated Summaries 2.6, Clinical Overview 2.5, Clinical Summary 2.7). This is the operational Spanish deliverable that carries reviewer read-time.
3. Full Spanish CTD Module 1 — country wrapper, always Spanish.
4. RTCA Anexo 2 Mutual Recognition packet — if the sponsor plans to file across Central America, the SRS-approved Spanish Module 2 + Module 1 becomes the reusable regional artifact for Guatemala, Honduras, Nicaragua, Costa Rica, and Panama.

For devices (RTS 11.03.02:21):

1. Original English biocompatibility, sterility, stability, risk analysis, electrical-safety reports — accepted at SRS technical tier.
2. Per-study Spanish executive summary (1–3 pages) at the front of each technical report — method (ISO cite), test conditions, key results, pass/fail conclusion.
3. Consolidated Spanish technical summary cross-referencing every ISO report by study number and page.
4. ISO 15223-1 symbology on primary labels for the device label — elects symbology in place of castellano text under §6.3.4.d, eliminating one of the highest-volume DTP tasks in the dossier.
5. Castellano IFU for new equipment; bilingual IFU for used biomedical equipment per §6.4.3.e.

For clinical trials (Manual CNEIS):

1. Full Spanish protocol — mandatory.
2. Full Spanish ICF — mandatory, CNEIS-approved.
3. Investigator's Brochure in source language + Spanish summary — the operational escape valve for IB translation cost, unique to CNEIS in LATAM.

The two regulatory pathways trigger different translation obligations

Every LATAM regulator operates two related but separate regulatory pathways for a sponsor's product: (1) clinical-trial authorization, which is what allows the investigational product to enter a clinical study on the sponsor's timeline; and (2) market-access / sanitary registration, which is what allows the commercial product to be sold. These pathways trigger different translation obligations. The most common sponsor error is applying a market-access translation obligation (device IFU, primary label, secondary packaging) to a clinical-trial dossier where that obligation is not yet in force.

Pathway 1 — clinical-trial authorization

• Under Manual CNEIS, protocol and ICF must be full castellano and adapted to the subject's reading level.
• IB accepted in source language with a Spanish summary.
• Foreign health-authority letters as traducción oficial + apostille per DNM Guide C02-RS-01-UR_PF.GUI01 v06 §5.

Pathway 2 — market-access / sanitary registration

• Device primary label in castellano or ISO 15223-1 symbology per RTS 11.03.02:21 §6.3.4.d (DTP required if castellano text is elected; not required if symbology is elected).
• Device IFU / manuals: castellano for new equipment; source language and castellano for used, remanufactured, or reconditioned biomedical equipment per RTS §6.4.3.e (DTP required).
• Drug labelling in castellano per RTCA 11.03.59:18 (with Anexo 2 Mutual Recognition allowing a regional master + country overlays across CA-6).

For each document class in this guide's consolidated preclinical instruction table below, check which pathway it is scoped to before authorizing translation. A document that requires DTP-scope translation for market registration may require only text-flow translation — or no translation at all — for clinical-trial authorization.

D.4 Consolidated preclinical instruction table

D.5 Where the preclinical translation risk actually sits

The common defect is conflating traducción oficial scope with technical-document scope. Sponsors sometimes pay for traducción oficial of biocompatibility reports (unnecessary; SRS accepts them in English with Spanish summary) or file legal-administrative documents with only a sponsor-QA-signed translation (insufficient; DNM Guide C02-RS-01-UR_PF.GUI01 v06 §5 requires traducción oficial for legal-administrative documents). The device-label symbology option under §6.3.4.d is the single largest cost reducer in the SRS translation surface and is routinely under-elected.

D1. Drug market access — SRS pathway

Governing instruments.

• Ley de Medicamentos — Decreto Legislativo No. 1008 (2 March 2012) (Ley de Medicamentos)
• Reglamento General de la Ley de Medicamentos — Decreto Legislativo No. 245 (20 December 2012)
• RTCA 11.03.59:18 — Productos Farmacéuticos. Medicamentos para Uso Humano. Requisitos de Registro Sanitario (Resolution 446-2021 COMIECO-XCIV, in force) (SRS RTCA)
• RTCA 11.01.02:04 — Etiquetado de Productos Farmacéuticos para Uso Humano
• RTCA 11.03.42:07 — Buenas Prácticas de Manufactura para la Industria Farmacéutica
• RTS 11.02.02:16 — Farmacovigilancia
• DNM guide C02-RS-01-UR_PF.GUI01 v06 — Requisitos para Registro Sanitario Farmacéutico (procedural guide inherited by the SRS Unidad de Registro de Productos Farmacéuticos)

Registration modalities under RTCA 11.03.59:18.

Language and translation stack.

• Product labelling: castellano — mandatory under RTCA 11.01.02:04.
• Insert / prospecto: castellano — mandatory under RTCA 11.01.02:04.
• *Foreign CPP, CFS, GMP certificate: apostilled + traducción oficial*** — required under DNM Guide C02-RS-01-UR_PF.GUI01 v06 §5.
• *Carta de Representación from foreign manufacturer to Salvadoran importer: apostilled + traducción oficial.*
• Stability studies, analytical validation, technical file: castellano recommended but the RTCA does not mandate sworn translation.

Fees under Ley Especial de Precios (LEPS-DNM, in force from 1 January 2024 — inherited by the SRS).

Reliance / recognition. Under RTS 11.03.02:21 §6.1.4(a), the SRS (formerly DNM) may recognize and use decisions, requirements, reports, or information issued by health authorities of countries whose drug regulatory agencies have been certified as level IV by PAHO/WHO*, and may recognize clinical trials authorized by high-surveillance agencies and by PAHO/WHO* (IMDRF — SRS El Salvador presentation). This reliance clause is one of the broadest in Central America and is often decisive for Latin-American filings by U.S., E.U., and Japanese sponsors.

D2. Drug regulatory submissions

Base dossier (RTCA 11.03.59:18 + DNM/SRS procedural guide).

1. Mandamiento de pago (proof of paid fees under LEPS-DNM)
2. Registration form
3. Certificate of Free Sale (CFS) — apostilled + traducción oficial
4. Certificate of Pharmaceutical Product (CPP) — apostilled + traducción oficial
5. Good Manufacturing Practices certificate — apostilled + traducción oficial
6. Manufacturing contract (if applicable)
7. Product technical file (quality, stability, bioequivalence when applicable)
8. Primary-package label proof — castellano
9. Secondary-package label proof — castellano
10. Insert / prospecto — castellano
11. Carta de Representación (foreign manufacturer → Salvadoran importer) — apostilled + traducción oficial
12. Analytical validation report
13. Stability study
14. Sample of finished product for quality control by SRS laboratory (where applicable)

Post-registration modifications. The SRS's 2025 regulatory agenda (AR-SRS-005) commits to publishing a Guía para trámites de modificaciones jurídicas posteriores al registro sanitario de productos regulados por la SRS in September 2025, and AR-SRS-002 covers device-specific post-registration modifications (SRS Agenda 2025). Until publication, DNM legacy procedures continue.

Renewal cadence. Sanitary registrations are valid for 5 years, must be renewed 6 months before expiry or up to 3 months after expiry — after which suspension and cancellation proceedings begin (RTS 11.03.02:21 §6.3.1.f). Annual fees (anualidad) must be paid to keep the registration active (RTS 11.03.02:21 §6.3.1.g).

Pharmacovigilance obligations. Under RTS 11.02.02:16 (Acuerdo 1529, in force from 17 October 2016), sanitary-registration holders must:

• Cooperate with the Centro Nacional de Farmacovigilancia (CNFV, dependent on MINSAL) (RTS 11.02.02:16 §6.2)
• Submit Informes Periódicos de Seguridad (IPS/PSUR/PBRER) when required as a condition of marketing authorization (SRS trámite IPS/PSUR/PBRER)
• Notify serious adverse reactions (RAM Graves) per the Lineamientos Técnicos de Farmacovigilancia (Acuerdo Ejecutivo AE-3111 of 22 December 2025) (Lineamientos FV 2025)
• Hold and demonstrate compliance with a Certificate of Good Pharmacovigilance Practices when required by the SRS (RTS 11.02.02:16 §6.3.6)
• File Plan de Gestión de Riesgos (Risk Management Plan) for new medicines (SRS trámite PGR)

D3. Drug clinical trials

Authorization architecture. El Salvador applies a dual-authorization model: ethics review by the CNEIS (national) or an accredited local CEIC/CEIS, and regulatory authorization by the SRS (formerly DNM). Ley de Medicamentos Art. 66 is the primary statutory anchor (Manual CNEIS).

Filing dossier for CNEIS review. Per the Manual CNEIS:

• Carta de intención
• Center authorization (signed by health-center authority)
• Full protocol in original language + Spanish translation (3 hard + 1 electronic copy)
• ICF in original + Spanish (adapted to subject reading level, ≤2 pages, plain language, tested for comprehension)
• Investigator's brochure (original + Spanish summary)
• Product information
• GCP training certifications
• Health insurance certificate for participants — original + Spanish translation certified by translator + statement of coverage mechanism in El Salvador
• Principal investigator CV + co-investigator CVs
• Evidence of GCP training
• Sponsor-investigator payment documentation
• Proof of arancel payment when applicable
• Annex 2 checklist + drug evaluation form

CNEIS review timelines.

• Full pleno evaluation (studies with more than minimal risk): reviewers submit written evaluations electronically within 4 to 6 weeks (Manual CNEIS)
• Expedited evaluation (minimal-risk studies, minor amendments): reviewers submit within 7 days
• Studies whose sole purpose is to evaluate a specific program (not generalizable knowledge) do not require ethics review

Decision categories.

• Aprobado sin restricciones (ASR)
• Falta Información (FI) — approved with observations and requested amendments
• No aprobado (PRT / RCT) — rejected for technical or ethical reasons

SRS regulatory authorization (post-DNM). RTS 11.03.02:21 §6.1 grants the SRS (via its Unidad de Ensayos Clínicos) authority to:

• Authorize the clinical trial itself
• Authorize substantial amendments before implementation
• Authorize importation of the investigational product
• Inspect trial sites
• Suspend or halt trials for clinical, technical, or legal reasons
• Recognize clinical trials authorized by high-surveillance agencies and by PAHO/WHO (§6.1.4.a)

SRS 2025 regulatory agenda commitments (still in adoption pipeline as of August 2026 — status varies by item):

• AR-SRS-009 — Guía de Buenas Prácticas Clínicas (adoption target: June 2025)
• AR-SRS-012 — Regulación de ensayos clínicos (adoption target: July 2025)

These will supersede legacy DNM guidance once formally in force (SRS Agenda Regulatoria 2025). El Salvador is also currently debating a comprehensive Ley de Ensayos Clínicos, with the Comisión de Salud of the Asamblea Legislativa having approved a project in 2025 (El Salvador — Comisión de Salud).

Adverse-event reporting. Adverse events during a clinical trial must be reported to both the CNEIS/CEIC and the SRS during the investigation and until the period stipulated in the protocol (RTS 11.03.02:21 §6.1.1.h). Serious adverse reactions in commercialized drugs are notified under the Lineamientos Técnicos de Farmacovigilancia (2025).

E1. Device market access — SRS pathway

Governing instruments.

• Ley de Medicamentos — Decreto Legislativo No. 1008
• RTS 11.03.02:21 — Dispositivos Médicos. Requisitos para la Regulación Sanitaria de Dispositivos Médicos (in force 6 months after publication, per §10) (RTS 11.03.02:21)
• RTS 11.03.03:22 — Dispositivos Médicos. Buenas Prácticas de Manufactura de Dispositivos Médicos y su guía de verificación (based on ISO 13485:2016) (IMDRF — SRS)
• RTS 11.03.04:23 — Vigilancia Poscomercialización de Dispositivos Médicos. Tecnovigilancia

Classification (RTS 11.03.02:21 §6.3.1.a). Four risk classes, harmonized with GHTF and IMDRF principles.

Nature-based additional categories: IVDs, antiseptics/disinfectants for medical-hospital use, Software as Medical Device (SaMD), other devices.

E2. Device regulatory submissions

Base dossier (RTS 11.03.02:21 §6.3.2.1).

1. Mandamiento de pago
2. Device registration form
3. Certificate of Free Sale (CFS) — apostilled + traducción oficial recommended per DNM legacy guide
4. GMP certificate — apostilled + traducción oficial recommended
5. Quality-control specifications for the device
6. Manufacturing / maquila contract (if applicable)
7. Device technical sheet
8. Technical information of the medical device
9. Primary-package label proof — castellano or ISO 15223-1 symbology
10. Secondary-package label proof — castellano or ISO 15223-1 symbology
11. Risk-management report
12. Safety report and sanitary alerts report

Category-specific additions (RTS 11.03.02:21 §6.3.2.2–.5).

• IVDs (§6.3.2.2): IFU/insert, shelf-life/stability technical document, storage/transport conditions, cuali-cuantitative formula, safety data sheet, validation reports
• SaMD (§6.3.2.3): Components/accessories diagram, technical design report, cybersecurity/storage/communication report, verification-and-validation testing report, version history (resolved and unresolved anomalies/errors), obsolescence timeline, clinical-evaluation studies when applicable
• Antiseptics / disinfectants (§6.3.2.4): Insert, shelf-life, storage/transport, cuali-cuantitative formula, sterilization certificate (when applicable), container-closure document, MINSAL alcohol registration document, MINSAL alcohol quota document, effectiveness validation
• Other devices (§6.3.2.5): Components/accessories diagram (when applicable), insert (when applicable), shelf-life, storage/transport, cuali-cuantitative formula (when applicable), sterilization certificate (when applicable), drug-manufacturer GMP (for combination devices), safety data sheet (when applicable), clinical-evaluation studies

Language and translation stack — devices.

• Labels: castellano or ISO 15223-1 symbology (RTS §6.3.4.d)
• IFU / manuals for used, remanufactured, or reconditioned biomedical equipment: castellano + source language (RTS §6.4.3.e)
• Technical documents (design reports, cybersecurity reports, validation, clinical evaluation): no explicit Spanish translation requirement in the RTS
• *Foreign legal-administrative documents (CFS, GMP, manufacturing contracts, powers of attorney): must be legalized per national norms (RTS §6.3.2.1); Salvadoran practice — inherited from DNM Guide C02-RS-01-UR_PF.GUI01 v06 §5 — requires apostille + traducción oficial***

Validity, renewal, anualidad (RTS §§6.3.1.f–g).

• Validity: 5 years
• Renewal window: 6 months before expiry to 3 months after expiry
• Annual fee (anualidad) required to keep registration active
• Suspension + cancellation if renewal window closes without payment

Import requirements (RTS §6.4.1).

• Active sanitary registration
• Solvent anualidad
• Valid renewal
• Registered and solvent-anualidad importer
• Minimum 6 months to expiry for the imported product
• Absence of active sanitary alerts
• Original + copy of factura signed and stamped by Profesional Responsable and importing establishment
• Certificate of batch-release analysis available for sanitary inspection

Special import (RTS §6.4.2). Applies to devices for scientific research (with CNEIS-approved protocol + SRS favorable opinion), OPS/OMS procurements, personal or business use, product samples, diplomatic use, national health system use, donations, and public-health emergencies.

Essential principles of safety and performance (RTS §§5.2.1–5.2.2, aligned with WHO framework). The SRS may verify manufacturer compliance before, during, and after market introduction through technical documentation, sanitary inspections, or other evaluations deemed necessary (IMDRF — SRS El Salvador).

Post-market surveillance — tecnovigilancia (RTS 11.03.04:23). Every establishment must designate a Referente de Tecnovigilancia responsible for identification, registration, evaluation, management, follow-up, and timely disclosure of adverse events and incidents (RTS 11.03.02:21 §3.36, §6.2.1.b).

E3. Device clinical trials

The clinical-trial framework for medical devices operates under the same dual-authorization model (CNEIS ethics + SRS regulatory) with device-specific additions in RTS 11.03.02:21 §§6.1.1–6.1.3. Key sponsor obligations:

• Provide attestations of compliance with a quality-management system for device production (typically ISO 13485)
• Provide handling, storage, and disposal specifications
• Provide the investigator's brochure and protocol
• Declare quantities of investigational product and auxiliary products with justification tied to intervention type and patient number
• Notify deviations, adverse events, and incidents during the study
• At study end, notify for supervision of disposal of remaining, returned, or expired product
• Maintain inventory-control documentation
• Destroy investigational product per SRS procedures

The SRS's Unidad de Ensayos Clínicos is the successor operational unit; its 2025 regulatory agenda commitments (AR-SRS-009, AR-SRS-012) apply to both drugs and devices (SRS Agenda Regulatoria 2025).

Amavita's six defect classes mapped onto El Salvador's statutory surfaces. Each rejection pattern below is a live SRS/DNM-legacy failure mode observed in Salvadoran filings.

The single most consequential timing rule for foreign sponsors is not stated in calendar days. RTS 11.03.02:21 is deliberately silent on review windows; the SRS operates on procedural queues, and completeness of the initial submission — including the correct apostille-then-translate sequencing — is the primary lever a sponsor controls.

2023 — Legislative Decree No. 891. Ley de la Superintendencia de Regulación Sanitaria approved by the Asamblea Legislativa in November 2023, establishing the SRS as the successor autonomous authority (SRS Ley; Asamblea Legislativa).

2023 (December) — Ley Especial de Precios (LEPS-DNM). Sets fees for DNM/SRS services, in force from 1 January 2024 with gradual implementation. Introduces exemptions for public institutions, orphan drugs, and patient-requested unavailable products (LEPS-DNM; SRS press).

2024 (June 19) — Legislative Decree No. 30, reform to Ley SRS. Amends the SRS creation law: shifts entry into force from 9 August 2024 to 7 August 2024; introduces Article 39-A granting a 120-business-day dissolution period for the DNM to ensure uninterrupted continuity of pending procedures; reduces the four planned intendencias to two — Intendencia de Vigilancia and Intendencia de Registro e Inscripciones (Diario Oficial No. 129, T. 444, 8 July 2024; LatinAlliance; Salud y Fármacos).

2024 (August 7) — SRS begins operations. SRS legally succeeds DNM and absorbs registration functions of MINSAL, MAG, and CSSP (Dinero SV; SRS).

2024 (September) — SRS budget approved. Asamblea Legislativa approves USD 7,269,060 budget for SRS covering August–December 2024 — a 48.2% reduction from DNM's prior USD 14.03M annual budget (Diario Co Latino; La Prensa Gráfica).

2025 (January 31) — First Superintendente appointed. MSc. Noé Geovanni García Iraheta (previously Director Nacional de Medicamentos) named as first Superintendente de Regulación Sanitaria (Portal de Transparencia).

2025 (March 24) — SRS Regulatory Agenda published. Includes commitments to publish 15 new regulations covering GCP, clinical-trial regulation, pharmacovigilance, cosmetovigilance, biological products, food registration, and post-registration modifications (SRS Agenda Regulatoria 2025).

2025 — Clinical Trials Law project. Comisión de Salud of the Asamblea Legislativa approves a project for a comprehensive Ley de Ensayos Clínicos, still pending plenary approval as of August 2026 (El Salvador — Comisión de Salud).

2025 (December 22) — Lineamientos Técnicos de Farmacovigilancia updated. Acuerdo Ejecutivo AE-3111 issued, updating spontaneous notification instruments and RAM classification procedures (Lineamientos FV).

2026 (April) — RTS 11.02.05:25 approved. Publication in Diario Oficial extends the RTS series covering pharmaceutical products (Jurisprudencia).

• Central American regulator overview: Global regulators post — paste-ready content
• Preclinical translation across 9 LATAM regulators (includes El Salvador section): Preclinical translation requirements — 9 LATAM regulators
• Sworn vs certified vs simple translation across LATAM: Sworn vs certified translation — regulatory submissions
• Spanish ICF readability standard: INFLESZ threshold — Spanish ICF readability
• RFI anatomy across LATAM regulators: RFI anatomy — six LATAM regulator rejections
• One-protocol-change amendment cascade: Amendment cascade — LATAM translation stack
• Three-band framework for LATAM translation: Three bands of LATAM regulatory translation
• Translation QC for regulatory dossiers: Translation QC — regulatory dossiers
• Costly translation mistakes across LATAM: Costly translation mistakes — regulatory submissions
• Platform vs traditional translation for LATAM regulators: Regulatory language infrastructure vs traditional translation