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Medical devices are regulated by the Medicines and Medical Devices Agency of Serbia (ALIMS).
Medical devices are classified according to the EU system of risk-based classification into Classes I, IIa, IIb, III, and IV.
Approval takes up to 90 days after registration documentations are submitted.
Licenses issued in Serbia are valid for three years.
An authorized representative is required.
Last updated on March 17 2015.
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