El Salvador offers a rare combination of speed, cost efficiency, and clinical quality for medical device early feasibility and first-in-human studies.
March 21, 2026
4
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
El Salvador
First-in-Human
Clinical Trials
Medical Devices
Latin America
Regulatory
The short answer: El Salvador offers first-in-human medical device trials with 3–5 month approval timelines, a dollarized economy, and costs 60% lower than the US. Compare early feasibility CRO options in Latin America and what trials cost across the region.
Why El Salvador for FIH trials?
El Salvador has emerged as a compelling destination for medtech early feasibility studies (EFS) and first-in-human (FIH) clinical trials. With 6.5 million people, a 65% urban population — making it the most densely populated country in the Americas — and a dollarized economy since 2001, El Salvador offers unique advantages for U.S. medical device startups looking to generate their first clinical data efficiently.
**🇸🇻 Dollarized Economy = Zero Currency Risk**
El Salvador adopted the U.S. dollar as its official currency in 2001, eliminating exchange rate risk for American sponsors — a significant advantage over other Latin American trial destinations where currency fluctuations can impact budgets.
How fast and predictable is the regulatory framework?
The Superintendencia de Regulación Sanitaria (SRS) — established in August 2024 as El Salvador's National Regulatory Authority, replacing the former Dirección Nacional de Medicamentos (DNM) — oversees clinical trials in El Salvador. The SRS is known for its digitally forward approach, implementing a "one-stop shop" that digitizes roughly 550 types of procedures. What sets El Salvador apart is that the regulatory and ethics review processes run in parallel through a unified digital platform, rather than sequentially. Both the SRS regulatory approval and the CNEIS ethics committee review are submitted and processed simultaneously, dramatically reducing the total approval timeline.
Review Track
Authority
Timeline
Process
Regulatory Approval
SRS
30–60 days
⚡ Parallel
Ethics Review
CNEIS
Total
—
Concurrent review
**🚀 One of the Fastest Approval Pathways in Latin America**
El Salvador's unified digital platform enables simultaneous regulatory and ethics review — a parallel process that compresses what would be a 2–4 month sequential timeline in most countries into 30–60 days. This makes El Salvador one of the fastest clinical trial approval pathways in the entire Latin American region, and a compelling choice for sponsors who need speed without sacrificing regulatory rigor.
**⚡ Pre-Submission & Post-Submission Meetings Available**
The SRS is open to pre-submission meetings and post-submission meetings, allowing sponsors to align their submission strategy with regulatory expectations before filing — reducing the risk of delays or additional information requests.
What clinical infrastructure does El Salvador offer?
Despite its small size, El Salvador has invested significantly in its clinical and healthcare infrastructure, making it well-suited for early-stage medical device trials.
- Hospital El Salvador houses Latin America's largest radiological center with cutting-edge Siemens technology.
- 31 Ministry of Health hospitals provide a broad clinical network for patient recruitment.
- 11 Social Security Institute (ISSS) facilities supplement the research network with additional sites.
- Digital healthcare network connects 90% of hospitals, enabling efficient data collection and monitoring.
- ISO 15189-certified laboratories ensure analytical quality meets international standards.
- 98.5% GCP compliance rate with international standards — among the highest in the region.
**🏥 Hospital El Salvador — A Regional Reference Center**
Hospital El Salvador is not only the country's largest public hospital but also houses Latin America's largest radiological center, equipped with state-of-the-art Siemens imaging technology. This makes it particularly attractive for device trials requiring advanced imaging endpoints.
What are the cost advantages?
Cost efficiency is one of El Salvador's strongest value propositions for medical device clinical trials. Sponsors can expect significant savings without compromising data quality.
- 60% lower costs than the United States for clinical research — including site fees, investigator costs, and patient care.
- Mixed public-private funding model keeps institutional fees competitive.
- Product registration valid for 5 years, providing a long commercial runway post-trial.
- Dollarized economy eliminates currency exchange risk entirely.
💰 Bottom Line
For a typical early feasibility study enrolling 5–15 patients, El Salvador can deliver 60% cost savings compared to an equivalent U.S. study — while maintaining GCP-compliant data quality that is accepted by the FDA, CE marking bodies, and other international regulators.
Why should MedTech startups consider El Salvador?
El Salvador is particularly well-suited for early-stage medical device companies that need to generate their first human clinical data quickly and efficiently.
- Ideal for small patient populations (5–15 patients) typical of EFS and FIH studies.
- 96% of trial data accepted by international regulatory bodies including the FDA.
- Growing investigator community with increasing clinical research experience.
- Safety monitoring infrastructure with live adverse event tracking.
- Perfect for early feasibility and first-in-human studies where speed, cost, and quality are the three critical variables.
**🎯 The Sweet Spot for FIH Studies**
El Salvador's combination of ~30-day parallel regulatory timelines, 60% cost savings, and 98.5% GCP compliance makes it one of the most efficient destinations in Latin America for first-in-human medical device studies — especially for startups with limited budgets and aggressive timelines.
Who is already choosing El Salvador?
El Salvador is attracting a growing number of medtech and pharmaceutical companies for clinical research. From early-stage startups to global pharma leaders, sponsors are choosing the country for its streamlined regulatory pathway, skilled investigators, and cost-effective operations.
bioaccess® Clients
Avantec Vascular
Sangria® peripheral venous thrombectomy catheter
First-in-Human study
Ocumedex
Vizio™ aqueous microshunt for refractory glaucoma
Watershed Therapeutics
WT-03 Gemcitabine Intravesical System for non-muscle invasive bladder cancer
Other Notable Sponsors Active in El Salvador
Aurion Biotech
Horizon Surgical Systems
Hoffmann-La Roche
Merck Sharp & Dohme (MSD)
Novo Nordisk
Janssen Research & Development
Eli Lilly
Gilead Sciences
Novavax
Boehringer Ingelheim
Amgen
Note: Horizon Surgical Systems (Polaris surgical platform) operates as an independent sponsor and is not a bioaccess® client.
**📈 Clinical Trial Activity Is Surging**
According to ClinicalTrials.gov, El Salvador has seen a dramatic increase in new clinical studies — from approximately 5 new trials initiated in 2020 to 13 in 2023, representing a ~160% increase in just three years. This upward trend reflects growing global confidence in the country's clinical research capabilities.
How can bioaccess® help?
bioaccess® operates across 11 Latin American countries, including El Salvador. Our team matches each clinical program with the optimal country and site based on regulatory timelines, patient availability, investigator expertise, and cost structure.
Whether El Salvador is the right fit for your program — or whether another Latin American country better matches your specific device, indication, and regulatory strategy — we'll help you make that determination based on data, not guesswork.
Frequently asked questions
How fast is regulatory approval for FIH trials in El Salvador?
+
El Salvador offers approval timelines of 3–5 months from submission to first patient enrollment for first-in-human medical device trials — among the fastest in Latin America.
How much do FIH trials cost in El Salvador compared to the US?
First-in-human medical device trials in El Salvador cost approximately 60% less than equivalent US studies, driven by lower site costs, a dollarized economy that eliminates currency risk, and streamlined regulatory processes.
Does El Salvador use the US dollar?
Yes. El Salvador adopted the US dollar as legal tender, which eliminates currency fluctuation risk for US sponsors budgeting and contracting clinical trials.
Is clinical data from El Salvador accepted by FDA?
Yes. Under 21 CFR 812.28, FDA accepts clinical data from foreign sites provided the study was conducted under GCP (ISO 14155), the data is valid, and subjects were adequately protected.
Ready to Explore El Salvador for Your FIH Study?
Let's discuss your device, your regulatory strategy, and whether El Salvador is the right destination for your first-in-human clinical trial.
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