Most medtech startups choosing a first-in-human trial site in Latin America ask the wrong question. They ask "which country is fastest?" Speed is the wrong axis — structure is what matters.
October 6, 2026
9
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
The five countries that matter most for device first-in-human work in Latin America in 2026 differ in structure, not speed. Chile is the most ethics-led (single committee gate, no device registration today but a dated window to March 2028). Panama is the most codified (Executive Decree 21, statutory clocks, verified Nanochon implant precedent). Costa Rica is the most supervised (double CONIS gate, 2-year insurance tail, 3% budget canon). El Salvador is the most regulator-heavy (DNM technical review before ethics). Brazil is the heavyweight: 90-business-day DICD deadline discipline, plus a narrowly caveated academic pathway that dispenses ANVISA assent but forfeits the data for future Brazilian registration.
Most medtech startups choosing a first-in-human (FIH) trial site in Latin America ask the wrong question. They ask "which country is fastest?" The honest answer is that speed is the wrong axis. The five countries that matter most for device FIH work in 2026 — Chile, Panama, Costa Rica, El Salvador, and Brazil — differ in structure: who reviews, what gates exist, what happens after the trial, and what the data can be used for. Pick the structure that fits your strategy, and speed follows.
Here is the framework, country by country.
Chile: the most ethics-led
Chile's pathway is the simplest on paper: a first-in-human device study needs approval from an accredited ethics committee (comité ético-científico, CEC) — no health-authority protocol review, no device-agency authorization for the trial itself. That is not a loophole; it is the deliberate design of a system that trusts accredited committees.
The commercial aftermath is where Chile gets interesting. Today, Chile requires no sanitary registration for most medical devices — only four categories (contraceptives, gloves, needles, syringes) must register. Everything else enters through a registered importer of record, a registered warehouse, and a per-shipment Customs Destination Certificate. But that window is dated: Exempt Decree 25 (published March 19, 2026) moves 39 device types into mandatory registration in tranches, with implantables and high-risk devices due March 19, 2028. A permanent implant studied in Chile in 2026–2027 must be registered before that deadline — so the post-trial plan has a clock on it from day one.
Two practical notes. First, Chilean private clinics commonly quote in Unidad de Fomento (UF), an inflation-indexed unit — peso exchange-rate moves do not make UF-denominated fees cheaper in real terms. Second, a certificate of free sale is the near-absolute blocker for any early registration: you cannot get a U.S. Food and Drug Administration (FDA) Certificate to Foreign Government for a pre-clearance device, so the correct sequence is Chile FIH on a research import certificate, then U.S. or European clearance, then freeze the design, then file — registered before the March 2028 tranche.
Choose Chile when: you want the lightest review structure, credible private-clinic infrastructure, and a commercial market you can enter without registration — provided your post-trial timeline respects the 2028 clock. Our Chile registration window analysis covers the full mechanics.
Panama: the most codified
Panama runs device FIH under Executive Decree 21, with statutory review clocks: the ethics committee and the Ministry of Health (Ministerio de Salud, MINSA) each work against defined timelines. Just as important are the gates sponsors forget — a research import permit, a licensed principal investigator, and site authorization all sit on the critical path before enrollment.
Panama's strongest recent signal is precedent. In August 2026, MINSA authorized the Nanochon Chondrograft study — a 3D-printed knee-cartilage implant, first patient treated September 2, 2026 at The Panama Clinic (ClinicalTrials.gov identifier NCT07542184). That is the first verified orthopedic-implant FIH under the Decree 21 framework: proof the codified pathway actually produces first-in-human implant studies, not just paper approvals.
On the commercial side, Panama requires device registration (sanitary registration, or registro sanitario) under Law 419 of 2024 — there is no Chilean-style open window. And Panama is dollarized, which removes foreign-exchange (FX) risk from budgeting entirely.
Choose Panama when: you want codified timelines, a verified recent implant precedent, and zero currency risk — and you accept that commercial registration is a separate, mandatory track. See our Decree 21 precedent analysis for the full case.
Costa Rica: the most supervised
Costa Rica's framework (Law 9234 of 2014, implemented by Executive Decree 39061-S of 2015) runs a double gate: approval from a National Council for Health Research (Consejo Nacional de Investigación en Salud, CONIS)-accredited ethics committee plus mandatory inscription of the protocol with CONIS itself. The study cannot start until CONIS issues its registration letter — typically within 10 business days of a complete filing, with committee review running about two to four weeks in practice. There is no Ministry of Health protocol review beyond that.
What distinguishes Costa Rica is sponsor obligation. Trial insurance must cover participants for two years after their participation ends. Investigators need civil-liability coverage. The sponsor must provide the device free of charge after the trial to participants who need it. The investigational product must be manufactured under Good Manufacturing Practice (GMP). And then there is the canon: Article 60 of Law 9234 requires payment to CONIS of 3% of the total research budget at project registration — a levy on the budget itself, with the sponsor contract routed through the ethics committee so CONIS sees the full number. The exemptions (Article 61) explicitly do not cover for-profit sponsors: a commercial medtech company always pays. On a $1 million FIH, that is a $30,000 line item no other Latin American country imposes. The import permit for trial devices issues only after both ethics and CONIS gates clear. For commercial sale afterward, device registration with the Ministry of Health is required, valid five years.
Recent FIH precedent exists — ophthalmology device studies in San José — but the supervised character is the point: Costa Rica demands more of sponsors than any of the other four, in exchange for a tightly overseen trial.
Choose Costa Rica when: your study benefits from maximum oversight credibility, you can carry the insurance and post-trial provision obligations, and your budget tolerates colón-denominated line items.
El Salvador: the most regulator-heavy
El Salvador is the most regulator-forward of the five. Under its Medicines Law (Ley de Medicamentos, 2012), the National Directorate of Medicines (Dirección Nacional de Medicamentos, DNM) reviews the device first — a technical authorization, typically around 30 days, that examines the safety and the efficacy of the design itself — and only then does the national ethics board (Comité Nacional de Ética en Investigación en Salud, CNEIS) review, another ~30 days. The sequence is fixed: regulator, then ethics.
Trial devices enter under a DNM special import permit; commercial sale afterward requires device registration (five-year inscription with annual license renewal). Like Panama, El Salvador is dollarized — the U.S. dollar has been legal tender since 2001 — so budgeting carries no FX risk. With about 6.5 million people, it is the smallest of the five, but recent early-feasibility activity is real: the Horizon Surgical "Polaris" study (recruiting since September 2025, San Salvador) and a Seger gastrointestinal device study (completed, started February 2026).
Choose El Salvador when: you want the regulator's technical view of your design before ethics review, you value dollarized budgeting, and your study size fits a smaller population.
Brazil: the heavyweight with two tracks
Brazil is not the simplest option — it is the biggest, at 215 million-plus people, and its new clinical-trials law (Law 14,874, sanctioned May 28, 2024) gives it something none of the other four has: statutory deadline discipline. For registration-directed trials of Class III and IV devices, the investigation dossier (dossiê de investigação clínica de dispositivos médicos, DICD) faces a 90-business-day review cap at the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA), after which tacit approval applies. Ethics review has also improved markedly — median times fell from 59 to 36 business days between 2024 and 2026.
Brazil's second track is the one drawing attention, and it needs careful handling. In December 2025, ANVISA's health-products technology unit (Gerência-Geral de Tecnologia de Produtos para Saúde, GGTPS) responded to a protocol consultation stating that a study of strictly academic and scientific character (caráter estritamente acadêmico/científico) with no sanitary-registration purpose is dispensed from prior ANVISA assent (dispensado de anuência prévia) under Collegiate Board Resolution (Resolução da Diretoria Colegiada, RDC) 837/2023 — proceeding on ethics-committee review (Comitê de Ética em Pesquisa, CEP, and where applicable the national commission Comissão Nacional de Ética em Pesquisa, CONEP) alone.
Three caveats, stated plainly. First, ANVISA was explicit that data from such a trial cannot support a future Brazilian registration dossier — the agency treats it as if it does not exist for regulatory purposes. Second, the opinion was project-specific, not general guidance; it does not bind inspections, import controls, or future reviewers. Third, the "academic" characterization fits poorly with a sponsor-driven commercial FIH — a study initiated, funded, and data-owned by a company to advance a foreign filing strains the ordinary meaning of academic, and the pathway is materially stronger when a Brazilian institution genuinely leads as sponsor of record. Import clearance per shipment (RDC 172/2017) still applies regardless of track.
Choose Brazil when: you need scale and deadline discipline (the DICD track), or when your study can be genuinely structured as academic research with no Brazilian registration intent — understanding exactly what the data can and cannot do afterward.
The decision rules
Stop ranking these countries on speed. Rank them on fit:
- Lightest review, commercial window open (but dated): Chile.
- Codified clocks, verified implant precedent, dollarized: Panama.
- Maximum supervision, heaviest sponsor duties: Costa Rica.
- Regulator-first technical review, dollarized, compact: El Salvador.
- Scale and deadline discipline — or a genuinely academic track: Brazil.
The common thread: every one of these pathways rewards sponsors who design the trial for the structure they're entering — not the structure they wish existed. Know which gates apply, what the data can be used for, and what happens the day after the last patient visit. The country that answers those three questions cleanly is your country.
Deeper reads on the individual pieces: our Chile vs. Panama head-to-head, the certificate-of-free-sale trap that governs every post-trial registration plan, and the four-country speed comparison.
This article is for informational purposes and does not constitute legal advice. Regulatory pathways change; confirm current requirements with qualified counsel before acting.
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