New Italian device registration requirements
Donawa, M.
Medical Device Technology 19(3): 26; 28-31
2008
ISSN/ISBN: 1048-6690 PMID: 18557406 Document Number: 617797
A medical device manufacturer located outside Europe was informed by an Italian distributor that the European Authorised Representative must designate the distributor as the authorised entity when registering the manufacturer's devices in Italy in a new online data bank. This is incorrect. This article discusses the new requirements for registering medical devices in Italy, together with the steps in the registration process and common problems encountered.
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