15 July 2009 : Deadline Extension of Italian Medical Device Registration

Published 15 Jul 2009

The Italian Ministry of Health had previously published an initial extension from the 31st December 2008 with a deadline on the 30th April 2009; which has now been further extended until December 31st 2009 by the Italian Ministry of Health for device registration for Medical Devices of ALL CLASSES (including Class I).

Here is the link to the announcement on the MoH website (in Italian language):
http://www.ministerosalute.it/dispositivi/newsDispo.jsp?id=669&lingua=italiano

Please remember:

1. Placing your medical device in Italy without completing the appropriate registration procedures is unproductive – it is only a matter of a few months.
2. The Registration proceedings require time in advance for completion due to the complexity of the process.
3. This registration does NOT need to be repeated every year (1 time action) – only prior to market entry!
4. Devices already circulating in the Italian market have a higher risk of control!
5. The registration of your device is your Property – do not allow commercial entities to register your devices (e.g. distributors) – you will lose control over your devices and free distribution.
6. Obelis as your appointed E.A.R is the right regulatory entity to complete the registration on your behalf (using the “smart card”, obtained from the Italian Authorities).

Click here to get your medical devices registered in Italy

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