Procedure for registration in the register of Class I medical devices
Class I medical devices are registered in the register of medical devices. Custom-made devices are not registered in the register of medical devices.
Applications for registration of a Class I medical device in the register of medical devices are submitted by medical device manufacturers having their registered place of business in the Republic of Croatia and by manufacturers’ authorised representatives having their registered place of business in the Republic of Croatia, who are registered in the register of medical device manufacturers.
The procedure for registering a medical device in the register of medical devices is initiated by a written application submitted to the Agency in Croatian language, not later than 15 days from the day of placing the medical device on the market.
The documentation to be submitted with the application is set out in Article 36 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).
Applications for registration of Class Is and Im medical devices are submitted separately, but devices covered by the same certificate of compliance may be grouped in one application.
