General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Georgia and is not affiliated with any contract research organization (CRO) named or linked here.
Georgia, the country in the South Caucasus, has become a recognized destination for first-in-human (FIH) and early feasibility studies (EFS) of medical devices, especially cardiovascular devices. If you are a U.S. or European MedTech founder searching for “first-in-human medical device trial Georgia”, this page covers the pathway as public sources describe it, what Georgia does well, and how a Latin American FIH compares.
The device-trial pathway in Georgia
Georgia adopted a technical regulation for clinical research of medical devices on 3 October 2023 (Government Resolution No. 386). According to a published summary by a Georgia-based CRO:
- The regulation references the Declaration of Helsinki, International Council for Harmonisation (ICH) good clinical practice (GCP), and ISO 14155:2020, the international GCP standard for device investigations.
- A trial needs a registration certificate from the national agency that regulates medical and pharmaceutical activities, plus a positive opinion from the local independent ethics committee of each participating institution.
- The sponsor needs a legal representative registered in Georgia.
- The dossier includes the protocol and the informed consent form (ICF) with notarized Georgian translations, the case report form (CRF), proof that the risk and liability of the trial are covered, manufacturing-standard documentation for the device, and written consent from each institution’s director and clinical lead.
- The same summary says the registration certificate is published on the ministry and agency websites within 20 working days of the application.
What is published about timelines
CROs that work in Georgia publish short clocks. One says clinical-trial approval takes less than two months, with local ethics review of 3–4 weeks followed by 3–5 weeks at the regulator. Another says local ethics approvals can come within 7 days and regulator approval within 30 calendar days when there are no questions. These timelines come from the CROs themselves, and some describe the general pathway rather than devices specifically. Ask for a written, device-specific calendar.
Standards and U.S. data acceptance
The U.S. Food and Drug Administration (FDA) accepts data from outside the United States for devices under 21 CFR 812.28 if the study is well designed and well conducted under GCP. That includes independent ethics committee review and informed consent, and FDA must be able to validate the data, by onsite inspection if it decides one is needed. The data can support an investigational device exemption (IDE), a 510(k), a De Novo request, or a premarket approval (PMA). Because Georgia’s device regulation references ISO 14155, it lines up with what FDA expects. Acceptance still depends on how each study is run.
Patients, sites and device experience
- Population: about 3.8 million (World Bank, 2024).
- ClinicalTrials.gov (28 September 2026): 90 interventional device records list a site in Georgia, and 14 of them have “device feasibility” as their primary purpose. Among the Eastern European, Central Asian and Latin American countries we compare, only Brazil has more records of that kind.
- Clinical Accelerator, a device CRO focused on the region, has a Georgia country lead and holds its annual Georgia MedTech Innovation Summit in Tbilisi. See our comparison page.
Recruitment reality: in a country of about 3.8 million, patients for a narrow indication tend to be concentrated in a few referral centers. Strict inclusion criteria can shrink the eligible pool quickly, and dynamics at a single hospital can affect enrollment. This is true of any small country, including Panama in Latin America. Ask for screening data from the named sites for your exact criteria.
Logistics from the United States
- Time zone: Tbilisi is on UTC+4 (Coordinated Universal Time plus four hours), 8–9 hours ahead of U.S. Eastern time depending on the season.
- Language: Georgian for submissions and consent documents.
- Local presence: a Georgia-registered legal representative is required.
- Check the U.S. Department of State travel advisory before you plan monitoring visits.
Genuine strengths
Georgia has a recent, device-specific rulebook tied to ISO 14155, short published approval clocks, a notable number of device feasibility studies relative to its size, and an experienced cardiovascular trial community. For structural heart and heart failure devices in particular, it is a credible choice.
How Latin America compares
- Same FDA rule: 21 CFR 812.28 applies in both regions.
- Time zone: Panama and Bogotá are 0–1 hour from U.S. Eastern, and Santiago and São Paulo 1–2 hours.
- Scale: Brazil (about 212 million people) and Mexico (about 131 million) give access to larger pools. Brazil has 1,170 interventional device records on ClinicalTrials.gov.
- 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 (Brazil’s health regulatory agency) plus ethics review.
- Continuity: bioaccess® is based in Miami, and its sister organization Amavita Research Services runs a Miami site for device and early feasibility studies.
- Trade-offs: Spanish or Portuguese documents, import permits, and regulators with differing predictability.
Other country guides: Uzbekistan · Kazakhstan · Armenia · Moldova · Ukraine · Serbia
Frequently asked questions
Does Georgia have specific rules for medical device clinical trials?
Yes. Government Resolution No. 386 of 3 October 2023 set out a technical regulation for clinical research of medical devices. A published summary says it references ISO 14155:2020 and ICH GCP.
Who approves a device trial in Georgia?
The national agency that regulates medical and pharmaceutical activities issues a registration certificate. The local ethics committee of each participating institution must give a positive opinion first.
How long does approval take in Georgia?
CROs working in Georgia publish timelines of under two months. There is no single official device-specific figure, so ask for a written calendar.
Will the FDA accept first-in-human data from Georgia?
It can. Under 21 CFR 812.28, FDA accepts data from outside the United States when the study follows GCP and FDA can validate the data. The decision is made case by case.
Do I need a local entity in Georgia?
A published summary of the 2023 regulation says a legal representative registered in Georgia is required.
Next step
Comparing Georgia with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.