General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Armenia and is not affiliated with any company named here.
Armenia appears on the coverage maps of some device contract research organizations (CROs), including Clinical Accelerator’s. If you are a MedTech founder weighing Armenia for a first-in-human (FIH) or early feasibility study (EFS), this page explains how device trials are regulated according to public sources, what Armenia offers, and how a Latin American start compares.
How device trials are regulated in Armenia
- Device trials fall under a Eurasian Economic Union rule. Armenia is a member of the Eurasian Economic Union (EAEU). A 2024 Chambers Global Practice Guide chapter by an Armenian law firm says device clinical trials are governed by Decision No. 29 of the Council of the Eurasian Economic Commission (12 February 2016). It also says that, although national law gives the government authority in this area, there were no national government decisions specifically on device clinical trials when the guide was written.
- Who does the expert work: since Government Decision No. 1795-N (24 November 2022), expert evaluations and inspections for medical devices have been carried out by the Center of Drug and Medical Technology Expertise under the Ministry of Health, according to the center’s own website. The center’s remit includes reviewing clinical-trial protocols and monitoring ongoing trials.
- How medicines trials are authorized (for context): the Ministry of Health grants permission based on a positive expert opinion from the center and a positive opinion from the Ethics Committee for Clinical Trials. That process is set by Government Decree No. 168-N (28 February 2019). A 2022 law firm overview says the Ministry issues its order within two working days of receiving the ethics committee’s conclusion. Confirm with local counsel whether and how this sequence is applied to devices.
Practical takeaway: Armenia’s device-trial pathway relies on the regional EAEU rule rather than a detailed national device regulation. That is not necessarily a problem, but it means a sponsor should get a written regulatory opinion on the exact filing route before committing.
What is published about timelines
Apart from the two-working-day step for the Ministry order in the medicines process, we found no official end-to-end device timeline. Ask for 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. Run the study to ISO 14155, the international GCP standard for device investigations, whatever the local minimum.
Patients, sites and device experience
- Population: about 3.0 million (World Bank, 2024).
- ClinicalTrials.gov (28 September 2026): 36 interventional device records list a site in Armenia, and 2 have “device feasibility” as their primary purpose.
- Clinical Accelerator includes Armenia on its coverage map. See our regional comparison.
Recruitment reality: in a country of about 3 million, patients for a narrow indication are concentrated in a small number of hospitals. Strict inclusion criteria can shrink the eligible pool quickly, and one center’s priorities can set the pace of enrollment. The same caution applies to small Latin American countries. Ask for site-level screening data.
Logistics from the United States
- Time zone: Yerevan is on UTC+4 (Coordinated Universal Time plus four hours), 8–9 hours ahead of U.S. Eastern time.
- Language: Armenian. Confirm the translation requirements for the protocol and informed consent form (ICF).
- Check the U.S. Department of State travel advisory and current routings.
Genuine strengths
Armenia offers an established regulatory expert center with a trial-monitoring remit, EAEU-level harmonization, and a compact system where investigators and regulators are reachable. For a sponsor with a well-connected local partner and a device that fits the national referral centers, it can work.
How Latin America compares
- Same FDA rule: 21 CFR 812.28.
- Device-specific rules: Brazil regulates device investigations under ANVISA (Agência Nacional de Vigilância Sanitária) RDC 837/2023. 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.
- Scale: Brazil, Mexico and Argentina together have more than 380 million people (World Bank, 2024).
- 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 and investigational import permits.
Other country guides: Georgia · Uzbekistan · Kazakhstan · Moldova · Ukraine · Serbia
Frequently asked questions
What rule governs device clinical trials in Armenia?
A 2024 practice guide says device trials fall under Eurasian Economic Commission Council Decision No. 29 (2016), and that there were no specific national government decisions on device trials at the time.
Which Armenian body reviews device matters?
The Center of Drug and Medical Technology Expertise under the Ministry of Health carries out expert evaluations for medical devices. The Ministry of Health issues clinical-trial permissions.
Is there a national ethics committee?
Yes. For medicines, Armenia has an Ethics Committee for Clinical Trials whose positive opinion is required alongside the expert opinion. Confirm how this applies to devices.
Will the FDA accept data from Armenia?
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
Comparing Armenia with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.