General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Uzbekistan and is not affiliated with any company named here.
Uzbekistan is newer to device trials and is drawing attention from MedTech sponsors. ClinicalTrials.gov already lists device studies with Uzbek sites that are explicitly labelled first-in-human (FIH), such as NCT07811024 and NCT06700226. If you searched for “clinical trials Uzbekistan medical device”, this page covers the new rules, what the country offers, and how a Latin American FIH compares.
The 2026 device-trial regulation
The Minister of Health approved a Regulation on the procedure for conducting clinical trials of medical equipment. It was registered by the Ministry of Justice on 7 January 2026 (No. 3746) and published in the state language, Uzbek. According to the legal news service Norma.uz, it entered into force on 26 February 2026. Summaries by Norma.uz and a Tashkent law firm describe these main points:
- Exemptions from clinical trials for registration: Class I (low-risk) devices, in vitro diagnostics prequalified by the World Health Organization (WHO) or registered with WHO support, devices already clinically tested in Uzbekistan, and, per the law firm, some devices with a proven record of safe use.
- Who decides: an Expert Council of the Ministry of Health decides whether a trial is required, on the recommendation of the Center for the Safety of Pharmaceutical Products.
- Minimum size: trials under the regulation must enroll at least 20 subjects, scaled to the device’s risk class, and multi-center designs are possible for higher-risk devices.
- Parallel review: under the medical device registration rules adopted in November 2025, laboratory testing and specialized expert review run at the same time. An independent expert checks the clinical site, the trial design and the assessment methods.
- Ethics: a trial cannot start without a positive opinion from the designated ethics committee. Written informed consent is required.
- Sponsor duties: providing the device, insuring subjects, monitoring and auditing, and reporting adverse events.
An important caveat for FIH planning: the regulation is written around state registration in Uzbekistan. How it applies to a foreign sponsor’s small FIH protocol that is not aimed at Uzbek registration, including the 20-subject minimum, is something to confirm in writing with local regulatory counsel before you commit.
What is published about timelines
We found no official end-to-end timeline for device trials under the 2026 regulation. Because the rules are new, treat any quoted clock as an estimate until you have a written, study-specific calendar.
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 is well designed and well conducted under good clinical practice (GCP), with independent ethics review and informed consent, and FDA can validate the data. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Plan to run to ISO 14155, the international GCP standard for device investigations, whatever the local minimum requires.
Patients, sites and device experience
- Population: about 36.4 million (World Bank, 2024).
- ClinicalTrials.gov (28 September 2026): 23 interventional device records list an Uzbek site, and 3 have “device feasibility” as their primary purpose. The footprint is small but growing.
- Clinical Accelerator lists Uzbekistan on its coverage map and names a country lead there. See our comparison page.
Recruitment reality: a large national population does not mean a large eligible pool at the sites you will actually use. Strict inclusion criteria and referral patterns concentrated in a few hospitals can slow enrollment. Ask for site-level screening numbers for your criteria.
Logistics from the United States
- Time zone: Tashkent is on UTC+5 (Coordinated Universal Time plus five hours), 9–10 hours ahead of U.S. Eastern time.
- Language: the regulation is published in Uzbek. Confirm the translation requirements for the protocol and informed consent form (ICF).
- Check the U.S. Department of State travel advisory and current flight routings before you plan visits.
Genuine strengths
Uzbekistan has a sizeable population, a brand-new device-trial rulebook with defined exemptions and a parallel-review design, and FIH device studies already on ClinicalTrials.gov. For sponsors who want an emerging geography with engaged investigators, it is worth evaluating.
How Latin America compares
- Same FDA rule: 21 CFR 812.28.
- Established pathways: Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária) regulates device investigations under RDC 837/2023, and our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
- Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination.
- Time zone: 0–2 hours from U.S. Eastern, compared with 9–10 for Tashkent.
- U.S. continuity: bioaccess® is headquartered in Miami, and 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.
Other country guides: Georgia · Kazakhstan · Armenia · Moldova · Ukraine · Serbia
Frequently asked questions
Does Uzbekistan have rules for medical device clinical trials?
Yes. A Ministry of Health regulation on clinical trials of medical equipment was registered on 7 January 2026 (No. 3746) and took effect on 26 February 2026.
Who decides whether a device trial is needed in Uzbekistan?
An Expert Council of the Ministry of Health decides, on the recommendation of the Center for the Safety of Pharmaceutical Products. A positive ethics committee opinion is required before the trial starts.
Is there a minimum number of patients?
Published summaries say trials under the regulation must enroll at least 20 subjects. Confirm how this applies to a small FIH protocol that is not aimed at Uzbek registration.
Will the FDA accept data from Uzbekistan?
It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate. The decision is made case by case.
Next step
Weighing Uzbekistan against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.