Two countries come up every time. Both are stable, both have credible private hospitals, both have moved faster than the region's giants. Yet nobody has ever compared them head-to-head — until now.
October 6, 2026
8
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
Chile and Panama differ in structure, not speed. Chile is ethics-led: one accredited committee (CEC) plus the establishment director's authorization, no ISP trial authorization for devices. Panama is codified: Executive Decree 21 routes trials through a CNBI-accredited Type II committee on a 20-business-day clock with parallel MINSA technical review. Neither demands efficacy data before FIH. The sharpest divergence is commercial: Chile lets you sell without registration today (dated window to March 2028); Panama requires a registro sanitario.
Ask a medtech founder where to run a first-in-human (FIH) device trial in Latin America and two countries come up every time: Chile and Panama. Both are stable, both have credible private hospitals, both have moved faster than the region's giants. Yet nobody has ever compared them head-to-head.
Here is the comparison — and the first thing to understand is that the real difference between them isn't speed. It's structure.
Two different machines
Chile is ethics-led. Under Law 20.120 and Supreme Decree (Decreto Supremo, DS) 114/2010, a clinical investigation is reviewed by an accredited ethics committee (comité ético-científico, CEC) — the committee of the health-service territory where the research is performed, or one engaged through a formal agreement (convenio). The director of the establishment where the research happens then authorizes the study following the committee's favorable report (Law 20.120, Article 10). In current practice, no trial authorization is issued by the ISP (Instituto de Salud Pública, the Public Health Institute) for device studies. One gate, one committee, one institutional signature.
Panama is codified. Law 84 of 2019, implemented by Executive Decree 21 (April 23, 2026), routes device trials through an ethics committee accredited by the National Bioethics Research Commission (Comité Nacional de Bioética de la Investigación, CNBI) at the Type II level — on statutory clocks: 20 business days for ordinary review, 10 for expedited. Alongside the ethics review runs a technical review by MINSA (Ministerio de Salud, the Ministry of Health). Written clocks are a genuine advantage. The honest qualification: the decree is roughly six months old. "Codified" also means lightly tested — including committee re-accreditation under the new regime.
So the structural choice is this: Chile's simpler single-gate machine, built on practice, versus Panama's written clocks, built on a brand-new decree. Neither is the wrong answer. They fail in different ways, which is what the rest of this post is about.
The gates founders forget
Founders fixate on the ethics clock and miss the gates that actually determine the timeline. Three of them matter in both countries.
Device import. In Chile, the ISP import authorization for the investigational device is a current requirement — not a post-2028 consequence of the registration reform — and it belongs on the critical path with the ethics submission, not after it. In Panama, importation needs its own importation permit supported by the ethics approval letter and the investigator's brochure, with a designated importer of record. In both countries, the device does not simply walk through customs because the trial was approved.
Insurance and liability. Panama requires clinical-trial insurance in the submission package. Chile goes further: mandatory participant insurance, a sponsor liability regime for trial-related harm with an extended limitation period, and post-trial continued-access obligations under Law 20.850. For a permanent implant, the liability tail — not product supply — is the planning issue. In both countries, insurance placement starts with site contracting, not after ethics approval.
The parallel authorization. Panama requires registration in RESEGIS, the national research registry. Chile requires the establishment director's express authorization after the committee's favorable report. Neither is difficult; both are forgotten until they block first-patient-in.
The preclinical bar: the same safety case
Neither country demands a demonstration of efficacy before a first-in-human feasibility study. Panama's committee applies a safety-case and risk-benefit standard under Article 50 of Decree 21 — ISO (International Organization for Standardization) 10993 biocompatibility testing, bench performance, sterility and endotoxin testing, an ISO 14971 risk-management file, and the investigator's brochure — plus a credible scientific rationale for anticipated benefit. Chile's committees judge scientific validity and risk-benefit the same way, consistent with the draft good-clinical-practice guidance for device investigations from ANDIM (Departamento Agencia Nacional de Dispositivos Médicos, ISP's device agency). Generating efficacy evidence is understood to be the purpose of the study itself.
We have written the Panama preclinical position up in full — including the closest real-world precedent of what a committee actually accepted — as a companion read: Does Panama Require Efficacy Data or a Large-Animal Study Before a First-in-Human Device Trial?
After the trial: the commercial fork
This is where the two countries diverge hardest, and where most comparisons stop too early.
Chile is currently the only major Latin American market where a medical device can be sold commercially without a sanitary registration (registro sanitario): only four device types require ISP registration today, and everything else enters through a registered importer plus a per-shipment import certificate. That window is dated — Exempt Decree 25 (March 2026) brings 39 device types into mandatory registration, with high-risk implantables due March 19, 2028 — and the decree's transitory article creates a voluntary bridge to obtain the full registration early. The full mechanics, including why the early path is a post-clearance play rather than a pre-trial one, are in our companion post: Chile's Device Registration Window.
Panama requires a device registro sanitario for commercial sale under its medicines-and-devices framework (Ley 419 of 2024, which replaced Ley 1 of 2001). There is no equivalent window.
If your strategy includes generating revenue in the trial country after the study, Chile's window is a structural advantage no other major regional market offers. If your commercial plan is U.S. and Europe first, it matters less.
Cost: dollarized simplicity vs. peso reality
Panama is dollarized — budgeting is budgeting. Chile floats (about 973 pesos per dollar in early October 2026), which gives it a modest, FX-sensitive edge on local labor and facility costs. Two caveats keep it modest: Chilean private clinics quote in UF (Unidad de Fomento, an inflation-indexed unit), so peso moves do not cheapen UF-denominated fees in real terms; and the largest trial line items — the device, monitoring, insurance, central labs — are dollar-denominated in both countries. The peso's ±10–15% annual swings can erase the edge mid-study. Treat cost as a tiebreaker, not a decision driver.
The decision framework
Choose Chile when the simpler ethics-led machine matters more than written clocks; when your indication needs a deeper, older patient pool (19.9 million people, median age 38.4, versus Panama's 4.6 million at median 31.6); and when a post-trial commercial window without registration has strategic value. Accept in exchange: a practice-based (not statutory) timeline, the territorial-committee constraint, and an import authorization that must run in parallel from day one.
Choose Panama when statutory clocks and a demonstrated precedent matter more: the Nanochon Chondrograft authorization — MINSA, August 14, 2026, first patient September 2, 2026, at The Panama Clinic (ClinicalTrials.gov identifier NCT07542184) — is the first verified orthopedic-implant FIH under Decree 21, and it is documented end to end. (The same clinic's earlier Axoft first-in-human ran under the prior regime — site experience, not Decree 21 precedent.) Accept in exchange: a six-month-old decree, a MINSA technical track coupled to the ethics decision, and a registration requirement standing between trial and market. Our Decree 21 precedent analysis walks through the case in full.
One honest note: for a 10-to-30-patient early feasibility cohort, neither country is pool-limited. The binding constraints are site capability, referral flow, and ethics throughput — not raw prevalence. Pick the machine whose failure modes you would rather manage.
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