Obelis Launches the Croatian National Registration Service
As of June 18, 2013, all Medical Devices Class IIa, IIb, III, Active Implantable Medical Devices (AIMD) and In Vitro Diagnostic Medical Devices (IVD) marketed in Croatia must be registered with the Croatian Agency for Medicinal Products and Medical Devices (HALMED).
Manufacturers of Class I Medical Devices established outside Croatia are exempted from this requirement.
The aforementioned follows the promulgated Law on Medicinal Products, adopted by the Croatian Parliament during its session on June 14, 2013, and published in the Croatian Government Official Gazette, No.76/13.
Obelis, as a professional European Authorized Representative, can perform the registration procedure on behalf of Non-EU manufacturers. A registration application form is provided by HALMED and the file is submitted in an electronic format.
For more information, you can visit the following links:
- Medical Devices Act (Official Gazette No. 76/13) by the Croatian Parliament
- Agency for Medical Products and Medical Devices of Croatia
With more than 25 years of experience within the Medical Devices field, the Obelis team is available to answer any questions you may have about European directives and CE Marking and to guide you through the whole Croatian national registration procedure.
If you want to sell your devices in Croatia and require more information, do not hesitate to contact us!