Medical Device Clinical Trials in Serbia: Agency and Ethics Approval, Real Strengths, and How Latin America Compares

General information, not legal or regulatory advice. Sources were checked on 28 September 2026. bioaccess® does not run studies in Serbia and is not affiliated with any company named here.

Serbia is a non-EU country in the Western Balkans with a long clinical-trial history, and it appears on the coverage maps of some device contract research organizations (CROs), including Clinical Accelerator’s. If you are a MedTech founder weighing Serbia for a first-in-human (FIH) or early feasibility study (EFS), this page covers the pathway as the Serbian regulator publishes it, what Serbia offers, and how a Latin American start compares.

The pathway, from the regulator’s website

Serbia’s Medicines and Medical Devices Agency (ALIMS) says clinical trials of medical devices require two things:

1. an authorization, or for lower-risk studies a certificate of registration, issued by ALIMS, and
2. a positive opinion from the Ethics Committee of Serbia (ECS),

both under the Law on Medical Devices (Official Gazette of the Republic of Serbia No. 105/2017) and its implementing regulations. ALIMS states that the agency application and the ECS application are submitted through the Agency at the same time.

Authorization is required before starting investigations of:

• Class IIa devices intended for long-term use or that are invasive,
• Class IIb devices,
• Class III devices, and
• active implantable medical devices (AIMD).

Registration, which is a notification route, applies to post-market non-interventional studies, Class I devices, Class IIa devices that are not long-term or invasive, and performance studies of in vitro diagnostics. Academic (non-commercial) device trials follow whichever route applies.

Most FIH devices are Class IIb, Class III or implantable, so expect the authorization route.

What is published about timelines

The ALIMS device clinical-trials page does not state a review clock. Some legal guides cite statutory review deadlines, but check the current law and 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.

Patients, sites and device experience

• Population: about 6.6 million (World Bank, 2024).
• ClinicalTrials.gov (28 September 2026): 1,855 records of all types list a site in Serbia. Of these, 97 are interventional device records, and 3 have “device feasibility” as their primary purpose.
• Clinical Accelerator includes Serbia on its coverage map. See our regional comparison.

Recruitment reality: Serbia’s broad trial experience helps, but in a country of about 6.6 million, a narrow indication will draw on a handful of tertiary centers. Strict inclusion criteria can shrink the eligible pool quickly. Ask for site-level screening numbers.

Logistics from the United States

• Time zone: Belgrade is on UTC+1 (Coordinated Universal Time plus one hour) in winter and UTC+2 in summer, about 6 hours ahead of U.S. Eastern time. That is the closest of the Eastern European and Central Asian countries covered in our guides.
• Language: Serbian. 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

Serbia offers a clear, published split between authorization and registration by device class, a single national ethics committee filed at the same time as the agency application, deep trial experience relative to its size, and a European time zone.

How Latin America compares

• Same FDA rule: 21 CFR 812.28.
• Similar structures: Brazil also files ethics and regulatory reviews in parallel. ANVISA (Agência Nacional de Vigilância Sanitária) reviews novel devices at the same time as ethics, and our Brazil hub publishes 6–10 weeks combined.
• Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination. Argentina’s ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) regulates device clinical investigations under Disposition 969/1997. See our Argentina hub.
• Time zone: 0–2 hours from U.S. Eastern, compared with about 6 for Belgrade.
• 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 · Armenia · Moldova · Ukraine

Frequently asked questions

Who approves a device clinical trial in Serbia?

ALIMS, the Medicines and Medical Devices Agency of Serbia, issues the authorization or registration. The Ethics Committee of Serbia must give a positive opinion.

Are the agency and ethics applications filed separately?

No. ALIMS says both are submitted through the Agency at the same time.

Which devices need full authorization?

Class IIa devices for long-term use or that are invasive, Class IIb, Class III and active implantable devices. Lower-risk studies use a registration route.

Will the FDA accept data from Serbia?

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 Serbia with a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®.