Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
Panama's streamlined regulatory process through MINSA (Ministerio de Salud), with ethics review through committees registered with the Comité Nacional de Bioética de la Investigación (CNBI), makes it one of the fastest pathways to first-in-human clinical data in the Americas. With a fully bilingual medical workforce, US-dollar economy, and strategic geographic location, Panama is a strong choice for sponsors that want speed and simplicity — and bioaccess® runs it as part of a multi-country FIH platform rather than a single-country shop.
Panama has emerged as a premier destination for first-in-human medical device studies, offering a combination of speed, cost efficiency, and operational simplicity that is unmatched in the region. MINSA's regulatory framework is designed for agility — ethics committee approvals typically complete in 3–5 weeks, and the overall regulatory pathway is significantly less bureaucratic than Brazil's ANVISA or Mexico's COFEPRIS.
Panama's medical workforce is fully bilingual (Spanish/English), with many physicians trained at US medical schools and residency programs. This eliminates the language barriers that can slow communication between sponsors and investigators in other LATAM markets. The country uses the US dollar as its official currency, eliminating exchange rate risk for US-based sponsors.
bioaccess® has been active in Panama since the early 2010s, executing FIH studies for clients including Newrotex (world's first silk nerve guide implant), Watershed Therapeutics, and multiple cardiovascular device companies. Panama City's modern hospital infrastructure, combined with experienced investigators and bioaccess®'s on-the-ground coordination, enables rapid study execution from protocol to first patient.
Panama's Ministry of Health (MINSA) oversees clinical investigations through the Dirección Nacional de Farmacia y Drogas. The regulatory pathway for medical device clinical trials is streamlined compared to larger LATAM markets. Sponsors submit a clinical investigation application with the protocol, investigator brochure, informed consent, and insurance documentation. bioaccess® manages the complete submission process and maintains direct relationships with MINSA reviewers.
Ethics review runs through institutional bioethics committees (Comités Institucionales de Bioética de la Investigación) registered with Panama's Comité Nacional de Bioética de la Investigación (CNBI). These committees provide some of the fastest review timelines in Latin America — typically 3–5 weeks for first-in-human device studies. All bioaccess® protocols run under ISO 14155 and the Declaration of Helsinki, and clinical data is eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis (not a guarantee of clearance or approval).
Panama's medical workforce is among the most internationally trained in Latin America — many physicians completed residencies or fellowships at US institutions, and English fluency is standard at major medical centers. On the operations side, bioaccess® clinical monitors and project managers are ACRP-certified. bioaccess® was founded in 2010 by two interventional cardiologists — one Harvard-trained — and has coordinated FIH device studies at JCI-accredited hospitals in Panama City ever since.
Panama City is a 3-hour direct flight from Miami and serves as a regional hub with connectivity to all of Central and South America. The country uses the US dollar as its official currency (Balboa is pegged 1:1), eliminating exchange rate risk for US-based sponsors. Panama's modern banking infrastructure and international business environment make financial transactions straightforward.
| Metric | Panama 🇵🇦 | United States 🇺🇸 | Europe (EU) 🇪🇺 |
|---|---|---|---|
| Regulatory/ethics approval | 3–5 weeks (MINSA + EC) | 6–12 months (IDE + IRB) | 3–6 months (per-country CA + EC) |
| Cost per patient | $12K–$22K | $40K–$75K | $35K–$60K |
| Separate IDE/IND for EFS | Not required | Required | Varies by country |
| 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 |
| English-language operations | Fully bilingual workforce | Native | Varies by country |
| Direct flight from Miami | ~3 hours | Domestic | 9–11 hours |
Ranges reflect bioaccess® first-in-human medical device studies. Actual costs and timelines vary by device complexity, therapeutic area, and monitoring requirements.
Panama-only specialist CROs are a perfectly good choice when Panama is already the settled jurisdiction for your device, patient population, and FDA plan. They offer deep local focus and CNBI-registered ethics-committee experience.
bioaccess® runs your Panama trial as part of a multi-country FIH platform — Panama plus 9 other Latin American markets, U.S. FDA regulatory anchoring (Pre-Sub, IDE, 510(k), De Novo, PMA, HDE, IND), a 12-month protocol-to-LPLV written guarantee, and a documented FIH-to-Fortune-500 track record (Mitralign→Edwards, ClarVista→Alcon, ForSight VISION5→Allergan/AbbVie). If country choice is part of the strategy, that optionality de-risks site selection and enrollment.
See the full bioaccess® vs First In Humans comparison.
Panama offers some of the fastest regulatory timelines in Latin America. Ethics committee approval typically takes 3–5 weeks, and MINSA regulatory clearance can be obtained concurrently. Total time from protocol submission to first patient enrollment averages 6–8 weeks with bioaccess® coordination.
Per-patient costs in Panama range from $12,000–$22,000, making it the most cost-effective clinical trial destination in Latin America. A 10-patient FIH study typically costs $200K–$300K. The US-dollar economy eliminates exchange rate risk that can inflate costs in other LATAM markets.
Yes. Panama has one of the highest rates of English fluency in Latin America, particularly in the medical and professional sectors. Many physicians at major medical centers completed residencies or fellowships in the United States. This enables direct sponsor-investigator communication without translation delays.
bioaccess® has executed FIH studies in Panama across neurotechnology (Newrotex silk nerve guide — world's first human implant), urology (Watershed Therapeutics), cardiovascular devices, and spine/orthopedic technologies. Panama's investigator network includes experienced surgeons across these therapeutic areas.
Yes. Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review from Panamanian studies conducted under ISO 14155 guidelines with proper ethics committee and MINSA oversight. bioaccess® designs all Panamanian protocols with FDA submission requirements built in from day one. (eligibility for FDA submission and review — not a guarantee of clearance or approval)
Panama offers faster ethics approval (3–5 weeks vs. 4–6 weeks), lower per-patient costs ($12K–$22K vs. $15K–$25K), and bilingual staff. Colombia offers a larger site network, INVIMA Level 4 regulatory credibility, and deeper investigator pools in certain therapeutic areas. bioaccess® recommends the optimal country based on your specific device and requirements.
It depends on how settled your country choice is. If Panama is clearly right for your device, patient population, and FDA plan, a Panama-focused specialist with CNBI-registered ethics-committee experience is a natural fit. If country choice is still part of the strategy — Panama, but also Colombia, Mexico, Chile, and other Latin American markets — bioaccess® gives you a documented multi-country platform with U.S. regulatory anchoring under one FIH-only partner, so you're not locked into a single jurisdiction before the regulatory-fit review.
Last reviewed: July 2026
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