In Croatia, the governmental body responsible for regulating medical devices is the Agency for Medicinal Products and Medical Devices (HALMED). Devices are categorized into the following classes based on the risk they pose toward on the human body: Class I, Class IIa, Class IIb, and Class III, with each one being associated with a higher level of risk than the one before it.

 

After becoming a part of the European Union in 2013, Croatia’s regulations for medical devices coincide with the EU’s medical device regulations. Before registering a device in Croatia, a conformity assessment must be performed by a Notified Body. All devices must comply with all requirements to receive a proper CE Marking. CE Markings are valid for five years.

 

Manufacturers that do not have a tangible presence within the European Union must appoint an Authorized Representative to register their medical devices in Croatia. This Representative will be responsible for submitting all documentation required for product registration in Croatia to HALMED (required application documents can be found here under Article 12). All documents and device labels must be translated to Croatian.

Croatian forms for registration

In Croatia, Class I devices and Class IIa/IIb/III devices require different registration forms. The list of forms required for each have recently been updated under the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, no. 84/13). More information on which forms are required can be found here.

 

All Class I devices must be registered with the European Competent Authority (CA) in the country in which the manufacturer is located. If the manufacturer is located outside of the European Union, its Authorized Representative must register with the Croatia’s CA.

How long does registration process take?

The registration process typically lasts about 1-9 months, depending on the complexity and classification of the device.

 

Sources:

http://www.halmed.hr/en/Medicinski-proizvodi/Upute-za-podnositelje-zahtjeva-41/Postupak-upisa-u-ocevidnik-i-obavijesti-o-medicinskim-proizvodima/

http://www.mvep.hr/files/file/dokumenti/prevodenje/zakoni/zakon-o-medicinskim-proizvodima-nn-76-13-eng.pdf

https://2016.export.gov/industry/health/healthcareresourceguide/eg_main_092232.asp#P21_1023

https://www.who.int/medical_devices/countries/regulations/hrv.pdf?ua=1


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