Procedure for registration in the registers of medical device manufacturers and the register of Class I medical devices

The Agency for Medicinal Products and Medical Devices maintains:

a register of medical device manufacturers
a register of Class I medical devices

The procedure, method of registration and documentation for the registration of a manufacturer in the register of manufacturers; procedure, method of registration and documentation for the registration of a Class I medical device in the register of medical devices; and the content and notification method for the placing a medical device on the market are defined in 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).

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.

Register of 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.

Forms

The form for registration in the register of manufacturers, form for registration in the register of Class I medical devices and forms for notifications of placing on the Croatian market Class IIa, IIb and III medical devices and in vitro diagnostic medical devices are a component part 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). Forms suitable for electronic completion and a template of a list of medical devices can be found here.