The retail of medical devices is carried out by legal and natural persons who, in accordance with a separate law, have been authorised to carry out pharmacy activities and specialised retail stores selling medical devices which have been licensed by HALMED for the retail of medical devices.
Specialised retail stores may only sell those medical devices that meet all the requirements set out in the Medical Devices Act (Official Gazette, no. 76/13) and are suitable for such sale taking into account their intended purpose, or the circumstances in while the medical devices are envisaged for use. Specialised retail stores may only sell medical products in the manufacturer’s original packaging. As an exception, Article 49 of the Act stipulates that certain medical devices may also be sold outside pharmacies and specialised retail stores. The list of medical devices that may be sold outside pharmacies and specialised retail stores can be found here.
The requirements that must be met by natural and legal persons to carry out the retail sale of medical devices in specialised retail stores selling medical devices and the necessary documents and data for the issue of an authorisation to perform these activities are set out in the Ordinance on the Conditions for the Retail Sale and Issue of Authorisations to Specialised Outlets for the Retail Sale of Medical Devices (Official Gazette, no. 133/13). An authorisation for retail sale issued to a specialised store may also include the sale of medical devices via the Internet.
Legal and natural persons performing pharmacy activities in the Republic of Croatia who offer medical devices for sale remotely via the Internet must submit the following data to the Agency:
- the name and the permanent address of the point of sale from which it is engaged in the sales of medical devices,
- the date on which the sales activities started,
- the address of the web site used for the Internet sales and all relevant information necessary for the identification of the web site.
(3) The web site referred to in paragraph 2 of this Article used for the sale of medical devices must contain the following data:
- the name and the address of the company,
- the address of the point of sale of the medical devices,
- the name and surname of the owner or the relevant responsible person,
- the contact information of the Agency,
- the link to the web site of the Agency accompanied with the data on legal and natural persons engaged in the Internet sales of medical devices.