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 into Classes I, IIa, IIb, III, and IV. TIMEFRAME:
Approval takes up to 90 days after registration documentations are submitted. LICENSE VALIDITY:
Licenses issued in Serbia are valid for three years. AUTHORIZED REPRESENTATIVE:
An authorized representative is required.
Last updated on March 17 2015.
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