Why El Salvador Is Emerging as a Smart Destination for First-in-Human Medical Device Trials

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

Introduction

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.

Regulatory Framework: Fast and Predictable

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.

Clinical Infrastructure That Delivers

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.

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 MedTech Startups Should 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's 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 bioaccess® Can 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.

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.

Book a Meeting

Global Trial Accelerators

Regulatory updates & clinical trial insights for Latin America.

Subscribe

Stay ahead with clinical trial insights for Latin America — delivered to your inbox.

Browse & Subscribe