First-in-Human Trials in Central Asia, and When Latin America Is the Faster Second Geography

Where Central Asia FIH device trials actually run today, what ClinicalTrials.gov shows by country, and how Latin America compares as a second geography.

General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

U.S. and Israeli device companies are running first-in-human (FIH) studies in Uzbekistan and Kazakhstan, and in the nearby Caucasus. This page sums up what the public registry shows country by country.

Country snapshot (ClinicalTrials.gov)

Industry-sponsored studies with a site in each country and a start date in 2021 or later (ClinicalTrials.gov API v2, pulled 25 October 2026):

  • Uzbekistan: 36. See our Uzbekistan guide.
  • Kazakhstan: 24, mostly large pharma. See our Kazakhstan guide.
  • Kyrgyzstan, Tajikistan, Turkmenistan: no industry-sponsored studies listed on ClinicalTrials.gov in that window. That does not mean no trials run there; it means none are registered on that registry.
  • Nearby: Armenia 52.

Who facilitates these studies

The registry rarely names a CRO. In Uzbekistan, the only CRO named as a collaborator on industry device studies we found is Clinical Accelerator, on four studies (e.g. NCT07811024, NCT05592392).

One FIH, two regions

Atlanta-based Nyra Medical announced that its CARLEN first-in-human mitral study is running at centers in the Republic of Georgia, Paraguay and Uzbekistan (PR Newswire, 22 October 2025). Latin America and Central Asia are not either/or: a sponsor can enroll in both under one protocol.

Standards and U.S. data acceptance

The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.

How Latin America compares

  • Same FDA rule: 21 CFR 812.28.
  • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
  • Time zone: 0–2 hours from U.S. Eastern.
  • U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
  • Trade-offs: Spanish or Portuguese documents and investigational import permits.

More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Georgia · Armenia · Clinical Accelerator comparison · Vantage Clinical comparison

Frequently asked questions

Which Central Asian countries host industry device trials?

On ClinicalTrials.gov, Uzbekistan and Kazakhstan do; Kyrgyzstan, Tajikistan and Turkmenistan had no industry-sponsored studies listed with a 2021-or-later start as of 25 October 2026.

Will the FDA accept FIH data from Central Asia or Latin America?

It can, under 21 CFR 812.28, if the study follows GCP and FDA can validate the data. The decision is case by case.

Can one FIH run in Central Asia and Latin America?

Yes. Nyra Medical's CARLEN FIH runs in Georgia, Paraguay and Uzbekistan, per its 22 October 2025 press release.

Next step

Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.

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