Obtaining the Italian MoH database and Smartcard for Medical Devices

pkost

Trusted Information Resource
#1
The Italian MoH database has been in place for some time and there have been other threads on how to go about adding your product, unfortunately the links are now out of date and there was still confusion about how non Italian manufacturers could register.

I'm now in a situation where I may need to add some products

Is anyone able clarify how I (as a non Italian individual) would go about
1. Registering on the database
2. Obtaining the smartcard that is necessary


(I'm aware that I can use a consultant in Italy as a much easier solution....I would prefer not to)
 
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ca_moni

Starting to get Involved
#3
At this link
:)uhoh: link will follow in next post, I currently have only 9 post and cannot yet insert links )

you can find the instructions for foreign companies (in English) for gaining access to the Italian registration database.

Being Italy-based, I have unfortunately no info on the time required for the process (Italian companies obtain access to the database interface through a different channel )

Registration is due for devices pertaining to class IIa or higher.
Class I devices manufactured by foreign companies do not require registration, however, given the standard procurement practice by Italian public hospitals, having a registration number could make the invoicing process easier .

I hope this can help
 
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