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.
Other Europe (non-EU) Countries:
Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Switzerland, Turkey, Ukraine
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