When a device sponsor asks where to run a first-in-human study, the honest answer starts with clocks — the actual review gates in each country, not the marketing. Here are the four that move fastest right now, compared gate by gate.
October 5, 2026
10
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
The four fastest countries for first-in-human device trials in Latin America right now are Panama, Chile, Costa Rica, and El Salvador. Panama runs a 20-business-day ethics clock with a 30-day cap under its 2026 decree; Chile runs an accredited ethics committee (about 25 days in practice) with no ISP trial authorization; Costa Rica runs a 30-calendar-day ethics review plus a supervisory national registry; El Salvador claims a 15–20 business-day joint regulatory response on the region's youngest framework. Realistic startup from complete submission: 4–10 weeks across all four.
Why these four
Speed in first-in-human work is a function of review gates: how many there are, whether they run in sequence or in parallel, and whether the clocks are published or aspirational. These four countries share the structural features that make FIH fast — accredited ethics committees as the primary scientific-ethical gate, no multi-layer ministry protocol review, and a defined path for importing the investigational device. They differ in maturity, and the differences matter. Each section below states the gate, the clock, and the caveat.
Panama: the new operating rulebook
Panama went from principles to an operating rulebook on April 23, 2026, when Decreto Ejecutivo No. 21 implemented Titles III and IV of Ley 84 of 2019. Review runs through a CNBI-accredited ethics committee on statutory clocks: 20 business days for ordinary review, 10 business days expedited, with a 30-business-day total cap.
- High-risk track: a permanent implantable device routes to a Tipo II-accredited committee with parallel MINSA technical review — ethics plus the ministry's device channel, not ethics alone.
- Registry: RESEGIS national registration plus institutional conformity from the hospital.
- Preclinical bar: no mandated animal model or functional study — the committee applies scientific-validity and risk-benefit criteria. See our Panama FIH preclinical requirements analysis.
Realistic startup: 6–10 weeks from complete submission (estimate), with the investigational device imported under the research exception while the device regulation is finalized.
Chile: ethics-committee-led, no ISP trial authorization
Chile is ethics-committee-led: an accredited comité ético-científico approves the Plan de Investigación Clínica, and no ISP authorization is required for the trial — there is no health-ministry protocol review either. (ISP's device agency ANDIM published a 2025 draft guide for a provisional-use authorization of investigational devices, notified to the WTO in June 2026; it carries no adoption or entry-into-force date and is not currently in force.)
- Ethics clock: a 45-day legal ceiling; in practice, accredited committees move faster — La Serena's CEC averages about 25 total days for initial reviews on twice-weekly sessions.
- Watch item, not a gate: the ANDIM draft guide proposes a one-year provisional-use authorization with prior ISP approval for amendments — but as a notified draft with no entry-into-force date, it is not a current requirement. The 2028 decree horizon below is the real change to plan around.
- Horizon note: a new decree arriving around 2028 will tighten requirements for high-risk, technically complex products. For novel devices, the current window is open but narrowing.
Realistic startup: 4–8 weeks from complete submission (estimate), driven by the CEC review.
Costa Rica: ethics approval plus a supervisory registry
Costa Rica has run biomedical research under Ley 9234 (2014) and its regulation for over a decade — the most mature framework of the four. An accredited comité ético científico (CEC) is the primary gate, and every CEC-approved protocol must then be inscribed with CONIS, the national health-research council.
- Ethics clock: 30 calendar days for full-committee review from a complete submission (published benchmark from the CCSS regulation), 15 days expedited.
- CONIS is not a rubber stamp: inscription follows CEC approval, and if CONIS issues a precautionary measure that is not resolved, the study may not start or continue. File the inscription immediately; do not treat CEC approval as the final word.
- Structural advantage for devices: the CEC approval letter is the sole requirement for the Ministry of Health's import authorization of the investigational device — no separate import dossier.
- Insurance tail: budget for the longer reading — the law requires coverage through 2 years after the research ends; the regulation extends participant coverage to 3 years after participation.
Realistic startup: 6–10 weeks from complete submission (estimate): ~30 days CEC review plus CONIS inscription running after approval.
El Salvador: the fastest claimed clock, the youngest framework
El Salvador is the high-upside, higher-variance entry on this list. The former DNM became the autonomous Superintendencia de Regulación Sanitaria (SRS) in August 2024, and the SRS now authorizes device trials jointly with the national ethics committee CNEIS through a shared digital submission platform with parallel review.
- Claimed clock: 15–20 business days for a joint regulatory response — the fastest figure in the region, but an industry claim (site-network operator), not an official published timeline. Treat it as the target, not the guarantee.
- The law is not enacted: the dedicated clinical-trials bill received a favorable committee opinion in 2025, but plenary passage has not been verified. The framework rests on SRS authority, CNEIS, and general device regulations.
- Site base: 8 SRS-authorized research centers — a smaller footprint than the other three countries.
Realistic startup: 4–8 weeks from complete submission (estimate), built on the claimed joint-response clock plus site contracting.
Side by side
| Panama | Chile | Costa Rica | El Salvador | |
|---|---|---|---|---|
| Ethics body | CNBI-accredited committee (Tipo II for high-risk) | Accredited CEC | Accredited CEC | CNEIS (national) |
| Regulator gate | Parallel MINSA technical review (high-risk track) | None for the trial (ANDIM draft not in force) | CONIS inscription after CEC (can block) | Joint SRS + CNEIS authorization (parallel) |
| Published ethics clock | 20 business days / 30-day cap | 45-day ceiling; ~25 days in practice | 30 calendar days | 15–20 business days (industry claim) |
| Dedicated trials law | Ley 84 + Decreto 21/2026 | Ley 20.120 + DS 114/2010 | Ley 9234 + regulation (2014/2015) | Bill not enacted |
| Device import | Research exception (regulation pending) | Via ISP/ANDIM dossier | CEC letter suffices | SRS authorization |
| Realistic startup* | 6–10 weeks | 4–8 weeks | 6–10 weeks | 4–8 weeks |
*Estimates from complete submission, not statutory clocks. Variance sits in site contracting, import logistics, and reviewer questions — not in the published timelines.
The honest caveats
A ranking without caveats is marketing. Four, stated plainly:
- El Salvador's speed comes with the thinnest legal floor. The 15–20-day figure is the fastest claimed clock in the region and the least official. Sponsors comfortable with a young framework get speed; sponsors that need enacted-law certainty should weight Panama or Costa Rica.
- Chile's gate is the CEC — for now. No ISP trial authorization is currently required; the ANDIM provisional-use guide remains a notified draft. The 2028 decree for high-risk products is the change to plan around, not a hidden current gate.
- Costa Rica's second gate can block. CONIS inscription after CEC approval carries real supervisory power. The country's maturity is its strength; the two-step sequence is its cost.
- Clocks start at complete submission. Every timeline above assumes a complete, Spanish-language dossier. The most common delay in the region is not the committee — it is the sponsor's package.
Our position, stated plainly: bioaccess advises on U.S. EFS versus Latin America FIH strategy from Miami and executes first-in-human trials across 19 Latin American and Caribbean countries. We tell sponsors honestly which geography their program needs — including when the answer is "not the fastest clock, the most certain one" — rather than selling one answer.
Frequently asked questions
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