Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
El Salvador's parallel regulatory and ethics review process enables a 30–60 day startup timeline — among the fastest in Latin America. With a dollarized economy, ~160% growth in clinical trial activity since 2020, and bioaccess®'s established site network, El Salvador is the ideal destination for sponsors seeking speed-to-first-patient at dramatically lower cost.
El Salvador has rapidly emerged as one of the most compelling destinations for first-in-human (FIH) and early feasibility studies (EFS) in Latin America. In August 2024, El Salvador established the Superintendencia de Regulación Sanitaria (SRS) as its new National Regulatory Authority, replacing the former Dirección Nacional de Medicamentos (DNM) and consolidating health regulation functions. The SRS's unified digital regulatory platform enables parallel submission to both the regulatory authority and the Comité Nacional de Ética de la Investigación en Salud (CNEIS), compressing what is typically a sequential process into a 30–60 day startup timeline.
Between 2020 and 2023, El Salvador saw approximately 160% growth in clinical trial activity, driven by progressive regulatory modernization and bioaccess®'s active investment in site development. The country's dollarized economy eliminates exchange rate risk for US-based sponsors, while operational costs run approximately 60% below comparable US programs.
bioaccess® has been executing clinical studies in El Salvador since its earliest operations, building relationships with key investigators and clinical sites in San Salvador. Notable sponsors who have conducted FIH studies through bioaccess® in El Salvador include Avantec Vascular (Sangria® drug-eluting stent), Ocumedex (Vizio™ ophthalmic device), Watershed Therapeutics (WT-03), and Horizon Surgical Systems (Polaris platform). The SRS's openness to pre-submission meetings further accelerates the regulatory pathway.
El Salvador's Superintendencia de Regulación Sanitaria (SRS), established in August 2024, serves as the National Regulatory Authority overseeing clinical investigation authorization. The SRS replaced the former DNM and consolidated regulation of pharmaceuticals, medical devices, nutritional supplements, food, cosmetics, and other health products. Known for its digitally forward approach, the SRS operates a 'one-stop shop' that digitizes roughly 550 types of procedures. Its parallel processing model — allowing concurrent regulatory and ethics submissions — eliminates the sequential delays common in larger markets. The SRS is also notably open to pre-submission meetings, allowing sponsors to resolve protocol questions before formal filing.
The Comité Nacional de Ética de la Investigación en Salud (CNEIS) provides centralized ethics review for clinical trials in El Salvador. Unlike countries with fragmented institutional ethics committees, CNEIS's centralized model ensures consistent review standards and predictable timelines. The parallel submission with the SRS via the unified digital platform means ethics and regulatory approvals can be obtained simultaneously within the 30–60 day window.
San Salvador's hospital network anchors El Salvador's clinical trial infrastructure, with Hospital El Salvador serving as a flagship site featuring modern radiological and surgical capabilities. bioaccess® has pre-qualified sites across the capital with investigators experienced in cardiovascular, ophthalmic, urological, and orthopedic device studies. The compact geography of greater San Salvador simplifies multi-site coordination and monitoring.
Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from El Salvador for IDE submissions, provided studies are conducted under ISO 14155 guidelines with proper SRS authorization and CNEIS ethics approval. bioaccess® designs all Salvadoran protocols with FDA submission requirements integrated from day one, including 98.5% GCP compliance rates across its El Salvador site network. (eligibility for FDA submission and review — not a guarantee of clearance or approval)
| Metric | El Salvador 🇸🇻 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Study start-up | 30–60 days (parallel SRS + CNEIS) | 6–12 months (IDE + IRB) | 3–6 months (per-country CA + EC) |
| Cost vs. US program | ~60% lower | Baseline | ~15–25% lower |
| Regulatory + ethics submission | Parallel (one digital platform) | Sequential | Sequential |
| FDA data acceptance | Eligible for submission/review — 21 CFR 812.28 (ISO 14155) | Native | Yes, with justification |
| Currency / FX risk | US dollar — zero FX risk | US dollar | Euro / local — FX exposure |
| Ethics review model | Centralized (CNEIS) | Local IRBs | Per-country ECs |
| GCP compliance (bioaccess® network) | 98.5% | — | — |
Ranges reflect bioaccess® first-in-human medical device studies. Actual costs and timelines vary by device complexity, therapeutic area, and monitoring requirements.
El Salvador offers one of the fastest study startups in Latin America — approximately 30–60 days from submission to first patient enrollment. This is enabled by a unified digital platform that allows parallel submission to the SRS (regulatory) and CNEIS (ethics), eliminating the sequential delays common in other LATAM markets.
The Superintendencia de Regulación Sanitaria (SRS) is El Salvador's National Regulatory Authority, established in August 2024. It replaced the former Dirección Nacional de Medicamentos (DNM) and consolidated regulation of pharmaceuticals, medical devices, food, cosmetics, and other health products under one digitally-forward institution that digitizes roughly 550 procedure types.
El Salvador offers approximately 60% cost savings compared to equivalent US clinical programs. The dollarized economy eliminates exchange rate risk, and lower operational costs (site fees, investigator costs, patient stipends) make it one of the most affordable FIH destinations in the Americas.
Yes. Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from El Salvador when studies are conducted under ISO 14155 guidelines with proper SRS authorization and CNEIS ethics approval. bioaccess® maintains 98.5% GCP compliance across its Salvadoran site network and designs all protocols for FDA submission from day one.
bioaccess® has executed FIH studies in El Salvador across multiple therapeutic areas, including cardiovascular (Avantec Vascular Sangria® drug-eluting stent), ophthalmology (Ocumedex Vizio™), urology (Watershed Therapeutics WT-03), and surgical robotics (Horizon Surgical Systems Polaris platform).
El Salvador offers among the fastest startups (30–60 days vs. 4–6 weeks in Colombia, 3–5 weeks in Panama) and the lowest costs (60% savings vs US). Colombia offers deeper investigator pools and INVIMA regulatory credibility, while Panama offers bilingual staff and US-dollar economy (which El Salvador also has). bioaccess® recommends the optimal country based on your specific device, therapeutic area, and timeline requirements.
Yes. El Salvador has seen ~160% growth in clinical trial activity between 2020 and 2023, and bioaccess® has been active in the country since its earliest operations. Hospital El Salvador features modern radiological capabilities, and bioaccess®'s pre-qualified investigators have executed successful FIH studies for multiple US-based medical device companies.
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