The Italian Ministry of Health (MOH) has introduced new registration procedures for medical devices in Italy.  The new registration procedures have been introduced in two phases.   All medical devices introduced in Italy after May 1, 2007 must be registered according to the new procedures before medical devices can be sold in Italy. 

Companies that had registered medical devices with the MOH prior to May 1, 2007 under the previous system must re-register under the new procedures before December 31, 2008. Recently, the deadline date for registration has been extended to December 31, 2009.

U.S. companies should start the registration process now.

The following MOH website link provides information on the new registration procedures:

http://www.ministerosalute.it/dispositivi/paginainterna.jsp?id=395&menu=registrazione