The role of HALMED
Through its statutory activities, the Agency for Medicinal Products and Medical Devices is responsible, inter alia, for three crucial areas underpinning the care for health and safety of all users of medical devices: it keeps registers of medical devices marketed in the Republic of Croatia and of related economic subjects, it acts as a platform for the successful implementation of the vigilance system and it participates in the work of international bodies thus keeping us abreast with all recent regulations, interpretations of regulations and EU guidelines on medical devices.
Pursuant to Article 212 of the Medicinal Products Act (Official Gazette no. 76/13 and 90/14) the Agency carries out the following activities with regard to medical devices:
- performs the laboratory testing of medical devices
- provides expert advice from its scope of activities
- provides expert guidelines from its scope of activities
- maintains the register of medical device manufacturers, the register of medical devices and the register of medical device wholesalers
- analyses and evaluates adverse events in clinical trials of medical devices
- grants authorisation for the retail sale of medical devices in specialized retail sale outlets
- maintains the register of medical devices marketed in the Republic of Croatia
- monitors the vigilance and safety of medical devices
- carries out the procedure for classification of medical devices
- issues certificates of free sale of medical devices
- provides education and information about medical devices
- establishes international cooperation in the field of medical devices
- proposes harmonisation of regulations on medical devices with those of the European Union as well as with the regulations and guidelines of international institutions.
