Why Panama Is Emerging as a Top Destination for First-in-Human Medical Device and Biopharma Trials

A comprehensive guide to why Panama has become one of bioaccess®'s preferred destinations for first-in-human medical device and biopharma trials — based on direct operational experience.

March 28, 2026

14

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

Panama

first-in-human

clinical trials

medical devices

regulatory

ethics committee

Latin America

brain-computer interface

neurotechnology

**Key Takeaways**

• • Panama's EC-driven pathway enables 3–5 month timelines from submission to first patient — among the fastest in Latin America
• • No separate national device authority approval is required for early feasibility studies
• • bioaccess® has conducted novel neurotechnology FIH trials in Panama, including brain-computer interface implantation
• • Same time zone as US East Coast with direct flights from major US cities — simplifying sponsor oversight
• • Bilingual medical community reduces communication barriers in protocol execution and monitoring

**Who Is This For?**

This guide is for medical device CEOs, VP Clinical/Regulatory Affairs, and biopharma startup founders evaluating Latin American countries for first-in-human or early feasibility studies — particularly those developing novel technologies that need a fast, flexible regulatory pathway with experienced clinical infrastructure.

Panama: The Quiet Leader in First-in-Human Device Trials

Panama has quietly emerged as one of the most startup-friendly jurisdictions in Latin America for first-in-human (FIH) clinical trials, particularly for novel medical devices and advanced biologics that may not yet have regulatory clearance anywhere in the world.

While Brazil and Colombia receive more attention in clinical research discussions — by virtue of their larger populations and established regulatory agencies (ANVISA and INVIMA, respectively) — Panama offers a combination of regulatory simplicity, geographic convenience, and investigator quality that makes it uniquely attractive for early-stage device companies running their first clinical study.

This guide explains Panama's regulatory framework, examines why startups increasingly choose Panama over larger Latin American markets, and shares bioaccess®'s direct operational experience conducting novel device FIH studies in the country.

Section 1: Panama's Regulatory Framework for Clinical Trials

Panama's clinical trial regulatory framework is fundamentally different from countries like Colombia (INVIMA) or Brazil (ANVISA/CONEP). For investigational device studies — particularly early feasibility and first-in-human studies — Panama employs an ethics-committee-driven pathway that does not require separate national device authority approval.

This distinction is critical: it means the primary decision-makers for whether your investigational device study can proceed are the institutional ethics committee and the Comité Nacional de Bioética de Investigación (CNBI) — not a national regulatory agency applying a standardized product classification and review checklist.

The CNBI Process

The Comité Nacional de Bioética de Investigación (CNBI) serves as Panama's national bioethics committee for research oversight. For clinical trials, the CNBI provides national-level ethical review and oversight, while institutional ethics committees at individual hospitals conduct site-specific review.

The CNBI review process evaluates:

• Scientific merit and study design adequacy for the proposed objectives
• Risk-benefit analysis for the study population, including informed consent adequacy
• Investigator qualifications and site infrastructure appropriateness
• Preclinical data sufficiency — evaluated as a coherent safety narrative, not a GLP checklist
• Patient protection measures, including monitoring plans and stopping rules

EC-Driven Pathway Advantages

The EC-driven pathway offers several distinct advantages for early feasibility and FIH studies:

• Single review pathway: No dual-track approval (national authority + ethics committee) as in Colombia or pre-2024 Brazil
• Faster cycle times: CNBI review typically completes within 4-8 weeks, compared to 6-14 months for INVIMA novel device review
• Regulatory flexibility: Ethics committees evaluate risk-benefit narratives rather than applying rigid product classification checklists
• Direct investigator engagement: The reviewing committee can directly query the principal investigator, accelerating question resolution

Section 2: Why Startups Choose Panama Over Larger LATAM Markets

The natural assumption for many US-based device companies is that larger markets — Brazil (200M+ population), Mexico (130M+), or Colombia (50M+) — should be the default choice for Latin American clinical trials. But for early feasibility and FIH studies, the decision criteria are fundamentally different from those driving pivotal trial site selection.

For FIH studies, what matters most is speed to first patient, regulatory predictability, and operational simplicity — not market size or patient recruitment volume. On these criteria, Panama frequently outperforms larger markets.

Faster Timelines: 3-5 Months to First Patient

Panama's EC-driven pathway enables total timelines of 3-5 months from initial submission to first patient enrollment. This compares favorably to:

Proximity to the US

Panama City is a 3-hour direct flight from Miami and shares the Eastern Time Zone (EST) — making it one of the most logistically convenient Latin American destinations for US-based sponsors. This proximity means:

• Sponsor medical monitors can visit sites without full-day travel commitments
• Real-time communication during business hours — no time zone coordination challenges
• Direct flights available from Miami, Houston, New York, and other major US cities
• Device shipping and importation logistics are streamlined through Panama's efficient customs infrastructure
• The Tocumen International Airport hub connects to virtually every major Latin American city

Bilingual Medical Community

Unlike most Latin American countries where clinical trial documentation must be fully translated and investigator communication requires interpreters, Panama's medical community has significantly higher English proficiency. Many specialists in Panama City have completed residency or fellowship training at US or UK medical centers.

This bilingual capability reduces translation costs, accelerates protocol training, simplifies monitor-investigator communication, and minimizes the risk of miscommunication during critical study procedures.

Section 3: Real-World Experience — bioaccess® Case Studies in Panama

bioaccess® has direct operational experience conducting first-in-human studies in Panama involving some of the most complex device categories in clinical research:

**Case Highlight: Novel Brain-Computer Interface — Axoft**

bioaccess® conducted a first-in-human study of a novel brain-computer interface (BCI) device in Panama. This study involved the implantation of a soft, flexible neural interface designed to restore communication and motor function. The device represented a completely novel technology category with no predicate devices, no prior human clinical data, and R&D-grade preclinical testing.

Panama's EC-driven pathway enabled the study to proceed efficiently despite the device's novel nature. The country's regulatory framework evaluated the comprehensive risk-benefit narrative — including the investigator's expertise, the monitoring plan, and patient selection criteria — rather than requiring specific regulatory classifications or GLP certifications that didn't yet exist for this device category.

Beyond neurotechnology, bioaccess® has evaluated Panama as a site for orthopedic and musculoskeletal device FIH studies, leveraging the country's growing surgical specialty infrastructure and the increasing interest from US-trained Panamanian surgeons in participating as clinical investigators.

Section 4: Infrastructure and Investigator Quality

Panama City's hospital network has evolved significantly over the past decade, with several institutions now maintaining clinical research infrastructure suitable for device studies:

• Hospital Santo Tomás: Panama's largest public teaching hospital with subspecialty surgical capabilities and research infrastructure
• Hospital Nacional: Private hospital with US-standard facilities, advanced imaging, and surgical suites suitable for complex device procedures
• Instituto Oncológico Nacional: Specialized oncology center for oncology device and therapeutic studies
• Punta Pacífica Hospital (affiliated with Johns Hopkins Medicine International): US-standard private hospital with strong clinical research culture
• Growing network of private specialty clinics with GCP-trained investigators

A critical advantage: many Panamanian specialists, particularly in neurosurgery, cardiology, and orthopedics, have completed training at US medical centers — Harvard, Johns Hopkins, Cleveland Clinic, Mayo Clinic — and maintain active professional relationships with US institutions. This creates a cadre of investigators who understand both US regulatory expectations and Latin American clinical practice.

Section 5: Practical Considerations for Panama FIH Studies

For sponsors planning a first-in-human study in Panama, several practical considerations warrant attention:

Device Importation: Panama's customs infrastructure is among the most efficient in Latin America, reflecting the country's role as a major international trade hub (the Panama Canal, Colón Free Trade Zone). Investigational device importation for clinical studies is manageable with proper documentation — including the ethics committee approval letter, investigator's brochure, and importation permit. bioaccess® manages this process end-to-end.

Clinical Trial Insurance: Clinical trial insurance is required and available through regional providers experienced with investigational device studies. Premiums are typically $5,000–$15,000 depending on device risk classification and subject enrollment numbers.

Ethics Committee Submission Timeline: Sponsors should budget 4-8 weeks for ethics committee review (CNBI + institutional EC), plus 4-8 weeks for site preparation, investigator training, and patient screening. Total submission-to-first-patient timeline is typically 3-5 months.

Patient Recruitment Capacity: Panama City's metropolitan area (~2 million population) provides adequate recruitment capacity for early feasibility studies (typically 5-20 patients). For larger studies or rare disease indications, multi-site or multi-country designs may be necessary — bioaccess® routinely coordinates studies across Panama, El Salvador, and Brazil simultaneously.

Data Management and Monitoring: All bioaccess® studies in Panama use electronic data capture (EDC) systems with 21 CFR Part 11-compliant audit trails, remote monitoring capabilities, and real-time data access for sponsors. On-site monitoring visits are supplemented by centralized statistical monitoring to ensure data quality meets FDA submission standards.

Frequently Asked Questions

JM

Julio G. Martinez-Clark

CEO & Founder, bioaccess® · 15+ years leading clinical trials and device registrations across Latin America · Has personally overseen FIH studies in Panama, including novel neurotechnology implant trials. Direct operational experience with Panama's CNBI ethics review process.

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Ready to Run Your FIH Study in Panama?

Panama's combination of regulatory simplicity, geographic convenience, bilingual investigator quality, and demonstrated capability for complex novel device FIH studies makes it one of bioaccess®'s preferred destinations for early feasibility and first-in-human clinical trials.

Whether you're developing a novel neurotechnology device, an orthopedic implant, a cardiovascular device, or an advanced biologic therapy, Panama offers a fast, predictable pathway to your first clinical data — with FDA-acceptable GCP compliance built into every step.

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Related resources:

• Early Feasibility Device Trials in Latin America — /blog/early-feasibility-device-trials-latin-america-glp-gmp-sterility-requirements
• El Salvador FIH Trials — /blog/el-salvador-first-in-human-medical-device-clinical-trials
• Site Search & Selection — /site-search-selection
• First-in-Human CRO — /first-in-human-cro
• Clinical Trials in Panama — /clinical-trials-panama