Information to holders of the medical device registration about the changes related to Croatia’s accession to the EU
03.01.2013
The Agency for Medicinal Products and Medical Devices (HALMED) informs all the holders of the medical device registration, that from 1 June 2013, HALMED will cease to accept applications for registration of medical device manufacturers from legal entities in the Republic of Croatia who represent manufacturers with headquarters in the EU or EEA, as well as manufacturers with headquarters outside the EU or EEA territory, that already have an authorised representative in the EU/EEA.
More so, HALMED will cease to accept applications for notification of the risk class I of medical devices into the registry.
