Medical Device Registration and Approval in Serbia

General country-specific regulatory information is provided on this page for medical device registration and approval in Serbia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Serbia, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Serbia

REGULATORY AUTHORITY: Medical devices are regulated by the Medicines and Medical Devices Agency of Serbia (ALIMS).

CLASSIFICATION SYSTEM: Medical devices are classified according to the EU system of risk-based classification.

Medical Devices: Classes I, IIa, IIb and III.

IVD Devices: Similar to the EU – Annex II list A, List B, Self testing and all others.

TIMEFRAME: Approval takes up to 90 days after registration documentations are submitted.

Class I: The registration process takes about 90 days to complete.

Class II: The registration process takes about 90 days to complete.

Class III: The registration process takes about 90 days to complete.

IVD Devices: The registration process takes about 90 days to complete.

SPECIAL REQUIREMENTS:

Audits: There are no audit requirements.

Technical Local Tests: There are no local testing requirements.

Clinical Evaluation/studies: There are no requirements for Clinical Evaluations.

LOCAL FEES: It costs approx. $315 USD per registration.

Manufacturer registration: No manufacturer registration fees apply.

LICENSE VALIDITY: Licenses issued in Serbia are valid for five years.

LICENSE TRANSFER: Licenses can be transferred, but paperwork is required.

AUTHORIZED REPRESENTATIVE/LICENSE HOLDER: An authorized representative is required.

ADDITIONAL INFORMATION: The registration procedure for Medical Devices differs for those with CE-mark and those without.

Last updated on April 1, 2019.

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