General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Ukraine and is not affiliated with any company named here.
Ukraine has one of the larger clinical-trial footprints in Eastern Europe, and some device contract research organizations (CROs), including Clinical Accelerator, list it on their coverage maps. If you are a MedTech founder weighing Ukraine for a first-in-human (FIH) or early feasibility study (EFS) in 2026, this page sets out the public facts: the country’s trial experience, the operating environment, a device-regulation transition that is under way, and how a Latin American start compares.
Operating environment: martial law
Ukraine has been under martial law since 24 February 2022, introduced by Presidential Decree No. 64/2022. The official legislation portal shows the decree still in force, with a current version dated 25 July 2026. Any sponsor considering Ukraine should build this into site selection, monitoring plans, insurance, investigational device logistics and contingency planning. Also check the U.S. Department of State travel advisory. None of this reflects on Ukrainian investigators. It is simply part of planning responsibly.
The device regulatory framework and its transition
- Current framework: medical devices are regulated by technical regulations adopted by the Cabinet of Ministers in 2013. These are Resolution No. 753 for medical devices and Resolution No. 755 for active implantable devices.
- New technical regulation: on 10 June 2026, the Cabinet of Ministers adopted Resolution No. 759, a new Technical Regulation on Medical Devices that replaces the 2013 regulations. The official portal lists its entry into force on 18 December 2026, but the regulation itself applies from 31 December 2030, with transition provisions.
- Clinical investigations: the implementation plan attached to Resolution No. 759 includes approving a new procedure for conducting clinical investigations, along with an electronic clinical-investigation system inside a national medical device database due by December 2029.
- Market surveillance: Resolution No. 759 names the State Service of Ukraine on Medicines and Drugs Control as the market-surveillance authority for medical devices.
Practical takeaway: device clinical-investigation rules in Ukraine are moving toward a new framework. Get a written opinion from Ukrainian regulatory counsel on the exact filing route and ethics requirements that apply to your study today.
What is published about timelines
We found no official, device-specific end-to-end timeline for the current framework in the sources above. Ask for a written calendar and a contingency plan.
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. That includes onsite inspection if FDA decides one is needed, so factor in the practicality of inspections. The data can support an investigational device exemption (IDE), 510(k), De Novo or premarket approval (PMA) submission. Run the study to ISO 14155, the international GCP standard for device investigations.
Patients, sites and device experience
- Population: about 37.9 million (World Bank, 2024).
- ClinicalTrials.gov (28 September 2026): 2,721 records of all types list a site in Ukraine. Of these, 54 are interventional device records, and none has “device feasibility” as its primary purpose.
- ClinicalTrials.gov also lists a device study with a Ukrainian site that names Clinical Accelerator as a collaborator (NCT03484780). See our regional comparison.
Recruitment reality: trial experience is broad, but conditions can change quickly in wartime, and strict inclusion criteria shrink eligible pools anywhere. Ask for current, site-level screening data and a documented backup-site plan.
Logistics from the United States
- Time zone: Kyiv is on UTC+2 (Coordinated Universal Time plus two hours) in winter and UTC+3 in summer, about 7 hours ahead of U.S. Eastern time.
- Language: Ukrainian. Confirm the translation requirements for the protocol and informed consent form (ICF).
- Check the U.S. Department of State travel advisory before you plan any travel.
Genuine strengths
Ukraine has a large population, extensive international trial experience on ClinicalTrials.gov, experienced investigators, and a device framework being modernized along European lines.
How Latin America compares
- Same FDA rule: 21 CFR 812.28.
- Operating environment: the Latin American countries we work in are not under martial law. Check travel advisories for any country you choose, in either region.
- 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 (Agência Nacional de Vigilância Sanitária) plus ethics review.
- Scale: Brazil (about 212 million people) and Mexico (about 131 million), with 1,170 and 244 interventional device records respectively on ClinicalTrials.gov.
- Time zone: 0–2 hours from U.S. Eastern.
- 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, investigational import permits, and regulators with differing predictability.
Other country guides: Georgia · Uzbekistan · Kazakhstan · Armenia · Moldova · Serbia
Frequently asked questions
Are device clinical trials still possible in Ukraine?
ClinicalTrials.gov continues to list studies with Ukrainian sites. Martial law has been in force since February 2022, so plan carefully for logistics, monitoring and contingencies, and take current regulatory advice.
What regulation governs medical devices in Ukraine?
For now, the 2013 technical regulations (Cabinet Resolutions No. 753 and No. 755). A new Technical Regulation, Resolution No. 759 of 10 June 2026, applies from 31 December 2030.
Will there be a new procedure for device clinical investigations?
Yes. The implementation plan for Resolution No. 759 includes approving a new procedure for conducting clinical investigations.
Will the FDA accept data from Ukraine?
It can. Under 21 CFR 812.28, FDA accepts data from outside the United States from studies run under GCP that it can validate, including by onsite inspection if needed. The decision is made case by case.
Next step
Need a Latin American option alongside or instead of Ukraine? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.
Leave a Reply