General country-specific regulatory information is provided on this page for medical device registration and approval in Croatia.
We review our Regulatory Information frequently; please check back often for updates
REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Croatia, 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 and III.
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.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
Any person who places medical devices classified as Class IIa, IIb and III, in vitro diagnostic medical devices and active implantable medical devices on the market of the Republic of Croatia shall notify the Agency thereof within a time period not exceeding 15 days from the day on which these products are placed on the market.
For detailed device-specific compliance information for each market, including Croatia, to expedite the preparation of your medical device or IVD registration application.
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