Medical devices are regulated by HALMED, the Croatian Agency for Medicinal Products and Medical Devices. CLASSIFICATION:
Classification follows the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV. LICENSE VALIDITY:
Licenses issued in Croatia are valid as long as the validity of the device’s CE mark. AUTHORIZED REPRESENTATIVE:
An authorized representative is required.
Last updated on March 15 2015.
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