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Registration in Database and Repertory of Italian Ministry of Health
Manufacturers or persons responsible for the marketing of custom-made devices must register in the Database of the Ministry
The article 13 of legislative decree 46 of 24 February 1997, and subsequent revisions (corresponding to the article 14 of the MDD 93/42/CEE), obliges the Manufacturer of Medical Devices to register and transmit data requested by these articles solely in electronic format, by means of access to the portal of the Ministry of health.
In addition to the system of product registration in the database, Provisions in the 2003 Financial Law (Law 266/2002) introduced an additional system or registration, for those devices being purchased by the National Health Service, in a Repertory of Medical Devices
It has been considered necessary to include this second tool (the Repertory) within the first (the database), given that it was necessary to gather a subset of information from the wider set of data related to all devices marketed in Italy in order to enable the subjects concerned to register both tools with a single step.
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