Wholesale and import
The wholesale of medical devices may be performed by:
- legal and natural persons having their registered place of business in the Republic of Croatia who are registered in the Agency’s register of medical device wholesalers,
- legal and natural persons having their place of business registered in the European Union who meet the requirements relating to wholesale of medical devices in the Member State in which they have their place of business,
- manufacturers of medical devices for those medical devices that they manufacture and which meet all the requirements stipulated by the Act.
Wholesalers engaged in the import of medical devices from third countries must:
- ensure that the manufacturer has carried out the appropriate conformity assessment
procedure relating to the imported medical device, - ensure that the manufacturer has prepared the proper technical documentation on the imported medical device,
- identify the contact name and the contact permanent address on the device, packaging or in the technical documentation attached to the device concerned,
- be in the possession of the declaration of conformity at the point of import and, if necessary, keep available for inspection other relevant documentation certifying the conformity of the medical device concerned.
The wholesaler that repackages or rebrands a medical device, puts it on the market in the Republic of Croatia under its own name or makes changes which mean that the device is no longer covered by the original CE mark, is regarded as the manufacturer of the medical device and is subject to all provisions relating to medical device manufacturers, including the obligation to carry out a new conformity assessment of the medical device. However, this does not apply to activities of translation of instructions for use and labelling to Croatian language and supplying the instructions with the device in a way that does not influence the device within the packaging in an unfavourable manner, all in order to fulfil the language requirements prescribed in the Republic of Croatia.
The requirements and necessary documentation and data for registration of wholesalers of medical devices are set out in the Ordinance on Good Practice in the Wholesale Distribution of Medical Devices and on the Conditions for Registration in the Register of Wholesale Distributors of Medical Devices (Official Gazette, no. 125/13).
The necessary form for registration in the register of wholesalers in a form suitable for electronic completion may be found here.
