MEDICAL DEVICES DATABASE AND REPERTORY - NSIS REGISTRATION
As established by the DM 21 December 2009 outlining “Modifications and integrations of the decree of the Ministry of Health of 20 February 2007 governing “New conditions for the obligations provided for by Article 13 of the legislative decree of 24 February 1997, n. 46 and subsequent modifications, and for the registration of active implantable devices as well as for the registration in the repertory of medical devices”, all medical devices, placed on Italian market for first time starting from 1 May of 2007, must be register in the database of NSIS of Ministry of Health
The obligation to register in accordance with the new procedures applies to the following medical devices:
• class I, IIa, IIb and III devices;
• kits and assembled devices referred to in articles 12, paragraphs 2 and 3 of legislative decree 46/1997;
• active implantable devices.
Registering is mandatory for the following subjects:
a. medical device manufacturers, as defined by article 1, paragraph 2, letter f) of legislative decree 46 of 24 February 1997;
b. subjects referred to in Article 12, paragraphs 2 and 3 of legislative decree 46 of 24 February 1997;
c. other persons responsible for marketing of medical devices;
d. proxies properly appointed by the subjects referred to in letters a, b, c
All medical devices can be registered also in the Repertory of Medical Devices in order to make them accessible by Regions and Independent Provinces of Trento e Bolzano and by Health Districts for consultation and/or purchasing.
BYM!‘s professionals provide service in registering medical devises in the Database and in Repertory of Medical Devices of NSIS of Ministry of Health on behalf of Manufacturers or European Representatives (Mandatory) through delegation.