General country-specific regulatory information is provided on this page. Become a LICENSALE.COM
user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.
Medical devices are regulated by HALMED, the Croatian Agency for Medicinal Products and Medical Devices.
Classification follows the EU model of risk-based classification into Classes I, IIa, IIb, III, and IV.
Licenses issued in Croatia are valid as long as the validity of the device’s CE mark.
An authorized representative is required.
Last updated on March 15 2015.
Interested in obtaining fast market approval for your medical device or IVD in Croatia? REQUEST A FREE QUOTE>