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 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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