Croazia

The information on this page is valid and current as of october 2020. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page. Disclaimer


 

Regulatory Authority:
Agency for Medicinal Products and Medical Devices (HALMED).

Classification:
Class I, Class IIa, Class IIb, Class III.

Quality system:
In compliance with ISO 13485:2016 technical standard.

Procedure:
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.

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Applicant:
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.

Validity:
It depends on the validity of the CE mark.

Labeling 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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