Foreign companies too can enter Medical Devices directly into the Database and the Repertoire using the online functions available both in Italian and English; for this purpose the following steps have to be performed:

  1. Foreign company's legal representative detects the individual (whether Italian or not) or the company to delegate for entering data.

  2. The legal representative underwrites a specific notification written on headed paper aimed at transmitting the Ministry of Health , the data of the delegate for entering and updating medical devices data. Such notification, underwritten by the Company's legal representative, along with a copy of her/his piece of identification, must be sent to:

    Ministero della Salute
    Direzione Generale dei dispositivi medici e del servizio farmaceutico
    Ufficio 3
    Viale Giorgio Ribotta, 5
    00144 Roma

    • If the delegate is an individual (whether Italian or not), a written notification according to the facsimile individual's delegation (doc, 47 KB), has to be sent

    • If the delegate is a Company, it will be sent a notification made according to this facsimile: company's delegation (doc, 47 KB)
  3. If the delegate is an Italian company, it will follow the procedures provided for the Italian companies: AZIENDE ITALIANE

     
  4. If the delegate is an individual (whether Italian or not), she/he will have to be holder of an electronic signature certificate issued by one of the certification providers, according to Directive 1999/93/CE. Format of signed data must be PKCS #7 standard compliant.

  5. Following the receipt and verification of the notification under point 2), if the delegate is an individual, the Ministry of Labour, Health and Social Policy will register her/him as a user of the NSIS Security System providing her/him with a DM Manufacturer profile. The user will receive a first e-mail containing his/her user ID (like mixxxxx where xxxxx are numbers) and password to access the system for the very first time; a second e-mail confirming her/him DM Manufacturer profile for the Medical Device application will then follow.

  6. At the end of this procedure, the user will be able to use the functions for managing those medical devices for which she/he has a delegation within the database. The operative instructions are reported in the User manual - DM Manufacturer profile Version 8.4 13/04/2016 (pdf, 8 Mb). Ask technical assistance by sending a message to the following address: servicedesk@almavivaitalia.it or calling the phone number +39 06 64515014





File mass uploading of data

Alternatively, file mass uploading of data is also possible to allow the notification of more devices at the same time through the transmission of an xml file electronically signed according to Data and Flow Check document (pdf, 2 MB) Version 5.1, 16 July 2013, annexes (zip, 162 KB) and formatted XML schema (xml).


To be enabled to data transmission, the following steps must be followed.&

  1. The legal representative of the appointing company underwrites a specific notification written on headed paper - specific notification (doc, 43 KB) - aimed at transmitting the Ministry of Health, the data of the individual delegated for transmitting the medical devices data via mass uploading. Such notification, along with a copy of the legal representative's piece of identification, must be transmitted to: 

    Ministero della Salute
    Direzione Generale dei farmaci e dei dispositivi medici
    Ufficio III
    Via Giorgio Ribotta, 5
    00144 Roma


    If the appointing company wishes to operate for other companies, in different position, such notification will also contain their delegations, signed by their respective legal representatives along with a copy of their piece of identification.

  2. Following the receipt and verification of the notification under point 1), the Ministry of Health will register the delegated individual as a user of the NSIS Security System providing her/him with an XML_Manufacturer profile. To operate the delegated individual has to obtain an electronic signature certificate issued by one of the certification providers, according to Directive 1999/93/CE. Format of signed data must be PKCS #7 standard compliant.

  3. The user will receive a first e-mail containing her/him user ID (like mixxxxx where xxxxx are numbers) and password to access the system for the very first time; a second e-mail confirming her/him XML_Manufacturer profile for the Medical Device application will then followThe user will be contancted by Servicedesk@almavivaitalia.it for the necessary verification and she/he will then be informed as soon as it will be possible to sign using her/his electronic signature certificate.

  4. At the end of this procedure, before transmitting data the user has first to associate her/his user ID to both the appointing company and any other possible delegating company. After that, the user will have to electronically sign her/his association with these companies.

  5. On completion of this procedure, required exclusively before sending the very first data transmission, the user will be allowed to send data massively through the XML file.

  6. The user will then be able to check the elaboration result of those files sent to the Database, and then consult the rejects containing the detail of the error found. All of these operative procedures have been reported in the Data and Flow Check document (v. 2.4 of 10 December 2008).

Data di pubblicazione: 30 aprile 2007, ultimo aggiornamento 7 giugno 2016

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