Regulatory Authority

Agency for Medicinal Products and Medical Devices (HALMED).


I, IIa, IIb, III

Quality system

ISO 13485:2016

All Medical Devices are subject to registration.

In the case of a non-European Manufacturer, an Authorized Representative or Representative must be appointed.
Normally, CE marking is required.
All devices must be registered with the Croatian Authority. The Authorized Representative/Representative must notify the competent Authority within 15 days of placing the device on the market by submitting the required documentation based on the risk class of the device to be registered.


Authorized Representative or Representative.

Timeframe and fees

Timeframe: 2-3 months.
There is a total fee of HRK 225 for accessing the register of Medical Devices.


It depends on the validity of the CE mark.

Labelling and documentation language

The information on the label and the instructions for use must be in Croatian.
For devices intended for use by health professionals, it is possible to provide this information in another European language, provided that this is evidenced in a declaration by the health professional/user.

Useful information

The Croatian Regulatory Authority’s website is complete and constantly updated in both Croatian and English.
Like all the Countries of the European Union, Croatia will also adopt the New Regulation (EU) 2017/745 on Medical Devices. It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.

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