On the placing on the market of medical devices
The placing on the market of medical devices in the Republic of Croatia is regulated by the Medical Devices Act (Official Gazette, no. 76/13), 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) and 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).
The following terms are defined in the Act, among others:
- Wholesale of medical devices means purchase of medical devices and their resale to natural or legal persons with a view to performing their professional and registered activity, including purchase, receipt, storage, resale and delivery, with an exception of the delivery to the end user - sole customer.
- Retail of medical devices means ordering, storage, dispensing and resale of the medical device to the end user - intended for use by a sole customer.
- Import of a medical device means the wholesale of a medical device which has been imported from third counties to the territory of the European Union.
- Good practice in the wholesale of medical devices involves storage and transport standards relating to the wholesale of medical devices particularly ensuring the organisation, implementation and control of storage in line with the statutory requirements, as well as the transport of medical devices to wholesale users.
The Act adopted the acquis communautaire of the European Union and stipulates that medical devices may be placed on the market and begin to be used if they meet the essential requirements, if they have a certificate of compliance and if bear the CE marking.