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 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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  • info@arazygroup.com
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  • Canada V6H 3R9

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