Procedure for registration in the register of medical device manufacturers
Natural and legal persons having their registered place of business in the Republic of Croatia who carry out activities of manufacturing Class I, IIa, IIb, III medical devices, in vitro diagnostic medical devices, active implantable medical devices and custom-made devices are registered in the register of medical device manufacturers, as are, for manufacturers established in third countries, their representatives having their registered place of business in the Republic of Croatia and authorised to represent the manufacturer in the European Union, i.e. authorised representatives.
The procedure for registering manufacturers and authorised representatives in the register of medical device manufacturers is initiated by a written application submitted to the Agency in Croatian language, not later than 15 days from the day of commencing activities.
The documentation to be submitted with the application is set out in Article 12 of the Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, No. 84/13).
On the basis of the completed application, the Agency will adopt a decision approving the registration of manufacturers and authorised representatives in the register of medical device manufacturers.
