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First-in-human trials · Georgia · Uzbekistan · Latin America
Beyond Georgia
An honest look at Georgia, Uzbekistan, and Latin America for first-in-human MedTech trials.
Country comparison
Reviewed 29 September 2026
Approvals · enrollment · FDA data acceptance
General information, not legal advice
September 29, 2026
6
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
The short answer
Georgia was the default answer for first-in-human MedTech trials for nearly a decade. That era is ending — not because of one published regulation, but because the operating environment around Georgian trials has changed. Here is how Georgia, Uzbekistan, and Latin America actually compare.
30–60 days
The regulatory startup window across Panama, Chile, Costa Rica, and El Salvador — the operational window, not the exception.
In this analysis
Why sponsors are leaving Georgia
Uzbekistan: paper vs. enrollment
Latin America: the structural case
Side-by-side comparison
How to evaluate any geography
References
Add this insight to your email
Copy a concise sponsor-ready paragraph based on the article.
For the better part of a decade, Georgia was the default answer to a hard question: where should a MedTech startup run its first-in-human trial? Fast ethics committees, experienced investigators, and a regulatory system built to say yes made Tbilisi the path of least resistance for early feasibility work.
That era is ending. Sponsors — and the CROs that built the Georgia playbook — are quietly moving on. In September 2026, a MedTech startup developing a peripheral vascular device told us it had been steered off the “usual go-to-Georgia route” and into Uzbekistan after what its team called “the changes in Georgia” — and its leadership’s plain-English conclusion was that “Georgia’s going away.” The most common fallback, Uzbekistan, is proving that an ethics approval and a promising pre-screen are not the same thing as a trial that enrolls.
This is an even-handed comparison of the three geographies sponsors are actually choosing between right now: Georgia, Uzbekistan, and Latin America. We run first-in-human medical device trials for a living, so we have a point of view — but the facts below are the facts.
Georgia: the former default, and why sponsors are leaving
Georgia earned its reputation honestly. Ethics review was fast, investigators were experienced with Western sponsors, and the regulatory framework was predictable. For years, “the usual go-to-Georgia route” was exactly that: usual.
What changed is harder to pin to a single published rule — and honesty requires saying so. Our research could not locate a primary source confirming a specific post-2024 RAMPA rule change aimed at medical-device trials, and the European Commission’s Georgia 2025 report states plainly that there has been “no progress on medical devices”[4] — Georgia still has no medical-device law, and its device-trial pathway still runs through ethics committees rather than a formal regulator authorization step. Public sources through 2026 still show Georgia as an active clinical-trial destination: RAMPA cleared a Phase 3 clinical-trial application in July 2025[3], and service providers continue to market Tbilisi trial capacity. What has unambiguously changed is the operating environment around the trials, and the changes are all documentable. Since 2024, Georgia’s political turn — a Georgian Foreign Agents Registration Act adopted April 1, 2025 (in force June 2025) carrying criminal penalties for unregistered foreign-agent activity[6], plus amendments requiring government consent for foreign grants (both criticized by the Council of Europe’s Venice Commission in October 2025 for lacking legal certainty and imposing disproportionate obligations)[7], the US pausing $95M in assistance and suspending the strategic partnership[8], and the EU freezing the accession process[9] — has raised the country-risk bar for US sponsors and the CROs advising them. Separately, a GDPR-grade Law on Personal Data Protection took effect on March 1, 2024, tightening the rules on health-data handling and on transfers of clinical data out of Georgia[5]. And the FDA has signaled it will discard foreign clinical data it cannot verify — including data from sites that deny inspection access or condition access on the FDA signing agreements attesting to geopolitical principles it will not sign[10]. Meanwhile, Clinical Accelerator, which ran its Georgia MedTech Summit in Tbilisi in September 2024, announced no public 2025 edition we could find[11], and now describes its footprint as spanning Eastern Europe and Central Asia. The honest conclusion: “the changes in Georgia” are cumulative, not a single regulation — which is exactly the question we’d put to Clinical Accelerator’s founder, Dr. Nikolai Nikitin, directly on the Global Trial Accelerators podcast.
The practical effect is what matters to a startup CEO: the geography that used to offer speed and certainty no longer reliably offers either, and sponsors who built their timelines around Georgia are being forced to re-qualify new countries mid-program — the most expensive moment to do it.
Uzbekistan: what looks good on paper vs. what enrolls
When Georgia started closing, many sponsors followed their CROs to Uzbekistan. On paper, the logic holds: ethics approval is obtainable, hospitals report deep patient pools, and pre-screening can look excellent.
Consider a recent, real-world example. A MedTech startup developing a peripheral vascular device asked Uzbek sites to send six months of hospital patient data — a stack of archived, anonymized CT scans — to confirm the right population existed. The scans looked good. Eighteen months later, ethics approval came through. The trial launched.
Twelve weeks later, exactly one patient matching the device’s true indication had been identified. The pre-screened population and the enrolling population turned out to be two different things, and hospital dynamics the sponsor couldn’t see from abroad compounded the shortfall.
This is not an indictment of Uzbekistan, and it is not an indictment of any single CRO. It is a structural warning about a specific failure mode: paper feasibility without operational verification. A stack of CT scans from a hospital’s archive tells you what walked through the door historically. It does not tell you whether the right patients will walk through the door during your enrollment window, whether referral patterns will hold, or whether the investigator who signed the feasibility questionnaire controls the cath lab schedule.
The question to ask about any new geography is not “can we get ethics approval?” — it is “who has verified, on the ground, that our exact inclusion criteria will be met, by this investigator, at this hospital, in the next 90 days?”
Latin America: the structural case
Latin America answers that question differently because the model is built around it. The lead first-in-human markets (Panama, El Salvador, Chile, and Costa Rica) combine predictable statutory timelines with a site-selection process designed to prevent paper-feasibility failure.
Across these four countries, regulatory startup runs on two distinct, rapid archetypes rather than a sequential ministerial backlog:
1. Pure ethics committee approval — zero ministry bottleneck
Chile: Governed by Ley 20.120 and Decreto 114. Accredited Comités Éticos Científicos (CECs) operate under a mandatory 45-calendar-day statutory review clock. Under Chilean law, a favorable resolution from an accredited CEC is legally sufficient to start the trial at that clinical site; MINSAL does not evaluate research protocols. For medical devices, studies fall outside ANAMED’s centralized pharma IND review, and the Instituto de Salud Pública (ISP) simply verifies CEC approval to issue an investigational import clearance.
Costa Rica: Under CONIS oversight, approval from an accredited institutional CEC directly authorizes trial initiation at the site. The Ministry of Health does not conduct a redundant central protocol evaluation, keeping the entire startup focused on site-level ethics review within 30 to 45 days.
2. Centralized parallel review — simultaneous ethics and regulatory authority
Panama: Decreto Ejecutivo 21/2026 establishes a parallel review framework. Sponsors submit simultaneously to accredited Comités de Bioética de la Investigación (CBIs, which operate on a 20-business-day review clock) and to MINSA through the RESEGIS digital platform. This eliminates 60 to 90 days of sequential delay and yields study clearances in 30 to 45 days.
El Salvador: The regulatory authority (Superintendencia de Regulación Sanitaria, or SRS) and the national ethics committee (Comité Nacional de Ética de la Investigación en Salud, or CNEIS) review concurrently through the unified digital platform (SRS-CNEIS-ES). CNEIS plenary review runs 4 to 6 weeks, resulting in total clearance within 30 to 60 days.
In all four jurisdictions, 30 to 60 days is the operational window, not the exception. Every program runs under ISO 14155 and ICH GCP, with data packages built for FDA acceptance under 21 CFR 812.28 from day one.
Site selection is a 60-day discipline, not a questionnaire. The process that prevents paper-feasibility failures has five stages: a detailed feasibility questionnaire customized to the study’s exact inclusion criteria, a scoring matrix across candidate sites, interviews with the sponsor present, and then physical site visits — the CRO’s team and the sponsor’s team touring facilities together, meeting hospital owners, and sitting down with ethics committee leadership. Thirty to sixty days go into investigator selection alone, because selecting the wrong investigator at the wrong facility is what kills enrollment.
Your team scrubs in. For first cases, sponsor teams — physicians, proctors, biomedical engineers — routinely scrub in alongside local teams. That is not a courtesy; it is how procedural knowledge transfers and how first-patient risk is managed.
Twenty years of first-in-human medical device work, and nothing else. No vaccines, no pharma pivots — the entire operating model, from the feasibility questionnaire to the monitoring plan, is built for one thing: getting a novel device into its first human patients safely and fast. In peripheral vascular disease specifically, that includes programs like Avantec Vascular/Nipro’s peripheral studies across Colombia, El Salvador, and Mexico.
The comparison, side by side
Georgia
Uzbekistan
Latin America (Panama, El Salvador, Chile, Costa Rica)
Ethics / regulatory approval
Fast historically; country-risk environment shifting
Obtainable, but timelines less predictable
30 to 45 days (Panama, Chile, Costa Rica); 30 to 60 days (El Salvador)
Review model
Centralized, previously streamlined
Hospital-dependent dynamics
Dual rapid models: pure accredited CEC/IRB approval without ministry evaluation (Chile, Costa Rica) or concurrent parallel MOH + IRB review (Panama, El Salvador)
Feasibility verification
Historically strong investigator base
Archive data can mislead; verify on the ground
5-stage qualification incl. physical site visits with sponsor
Recruitment reliability
Declining as environment shifts
High variance; hospital dynamics hard to diligence remotely
Treatment-naïve populations; sponsor present for selection
FDA data acceptance
Accepted under standard OUS pathways
Built for 21 CFR 812.28 / ISO 14155 from protocol design
Cost per procedure
Moderate
Low
Low (~$5,000 vs. ~$50,000 US reference)
Sponsor oversight model
Varies by CRO
Sponsor team scrubs in for first cases (routine practice)
How to evaluate any geography (including ours)
Don’t take our word for it — or anyone’s. Ask these questions before committing to a country, a CRO, and a site:
- Show me the last six months of patients matching our exact inclusion criteria — not the disease area in general, our criteria specifically.
- Who physically visited the site, and when? A questionnaire returned by email is not diligence.
- Does the investigator control the schedule? Meet the hospital owners and the cath lab gatekeepers, not just the PI.
- What happens at week 12 if enrollment is at 10% of plan? Get the contingency in writing before you start.
- Is the data package being built for our FDA strategy from day one? Retrofitting FDA acceptability onto a foreign dataset is where programs go to die quietly.
The cheapest first-in-human trial is not the one with the lowest per-patient cost. It is the one that enrolls.
bioaccess® is The First-in-Human CRO, running first-in-human and early feasibility medical device trials across Latin America for 20 years. Book a meeting to talk through your program’s geography decision.
References
- Clinical Accelerator — company profile: “The Sponsor-Aligned CRO for First-in-Human and Early Feasibility Trials,” operating in Eastern Europe and Central Asia.
- ICH GCP clinical trials registry — Clinical Accelerator-sponsored trials in Georgia and Uzbekistan (VisCardia, Medlumics, Abbott Medical Devices).
- Moleculin Biotech press release, July 9, 2025 — Georgia’s Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) approved the Clinical Trial Application for the Phase 2B/3 MIRACLE trial; first patient in Georgia expected by end of August 2025.
- European Commission, Georgia 2025 Report (SWD(2025) 757 final, November 4, 2025) — “There has been no progress on medical devices.”
- DLA Piper, Data Protection Laws of the World — Georgia: the Law on Personal Data Protection was adopted on June 14, 2023, replacing the 2011 law; its main provisions entered into force on March 1, 2024, aligning Georgian data protection with GDPR principles.
- ICNL brief, April 2025 — Georgia’s Foreign Agents Registration Act was adopted by Parliament on April 1, 2025 and signed by the President on April 2; it requires individuals and entities acting at the request of a foreign principal to register as “foreign agents,” and introduces criminal penalties for violations.
- Council of Europe, Venice Commission opinion (adopted October 15, 2025) on Georgia’s Law on registration of foreign agents (GEOFARA) and amendments to the Law on Grants — obligations lack clarity and precision, are disproportionate; Anti-Corruption Bureau entrusted with excessively wide discretion.
- Interfax — US paused $95M+ in assistance to Georgia’s government on July 31, 2024, after the foreign-agents law (Secretary Blinken: “anti-democratic actions”).
- Congressional Research Service, September 2024 — EU leaders in June 2024 declared Georgia’s course “de facto leading to a halt of the accession process.”
- The FDAGroup Insider — the FDA will throw out foreign clinical trial data it cannot verify; if a foreign site denies access, or conditions inspections on signing agreements attesting to geopolitical principles unrelated to the inspection, the FDA will not sign and the data will be excluded.
- Clinical Accelerator — Georgia MedTech Summit, Tbilisi, September 20–22, 2024 (company-organized; no public 2025 edition found as of September 2026); company profile now describes operations across Eastern Europe and Central Asia.
- bioaccess® — “The Australian R&D Rebate Math, Honestly: Australia vs Latin America for First-in-Human & Early-Phase Trials.”
This country comparison reflects sources reviewed as of 29 September 2026. Regulatory practice changes; verify the current official text before making a filing decision. General information only, not legal advice.
Choose the geography that enrolls.
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