Regulatory Open Forum

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  • 1.  Register products in the Italian FABBRICANTEDM = MANUFACTURERDM

    Posted 23-Oct-2023 11:36

    Hello,

    Has anyone successfully been able to register products in the Italian (MoH) :

    FABBRICANTEDM = MANUFACTURERDM

    I've received my User ID (mixxxxxx), updated my PW and can access the NSIS system, however I don't seem to have access to anything that is described in the User Manual, Medical Device Manufacturer Profile, Version 9.2, 04/11/2021.

    It seems like I'm missing a URL or something.

    Thanks for any insights.

    J



    ------------------------------
    John Hartigan
    VP, QA/RA
    Rochester MN
    United States
    ------------------------------



  • 2.  RE: Register products in the Italian FABBRICANTEDM = MANUFACTURERDM

    Posted 23-Oct-2023 18:00

    Hi John

    The system requires you to have pop-ups enabled in your browser. If you haven't, then clicking the links appears to have no action at all.



    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------



  • 3.  RE: Register products in the Italian FABBRICANTEDM = MANUFACTURERDM

    Posted 24-Oct-2023 05:59

    Hi John,

    it is not clear to me if you have access to NSIS system or you not able to enter.

    If you enter, it would be ideal if you could share the printscreen of what you can see when you access the NSIS system. I have access to NSIS system through an electronic signature device on behalf of many companies, not using username and password but in any case when you enter into the system, the first page should be the same regarldess of the way you enter. 

    If you do not have access, it is likely that Anne is right and you need to have pop-ups enabled in your browser.

    I'm aware that it is not an easy system even for Italian speakers



    ------------------------------
    Carlo d'Alessandro
    Director, Quality and Regulatory
    Roma
    Italy
    ------------------------------



  • 4.  RE: Register products in the Italian FABBRICANTEDM = MANUFACTURERDM

    Posted 24-Oct-2023 12:46

    Wow - thanks for the quick responses!

    1. Anne, I did ensure that pop-ups are enabled (it seems they were already), but added again just to be certain. This did not have any effect.
    2. Carlo, I have attached some of the screen-shots of what I encounter:
    What I see upon logging-in to NSIS
    Account details (all greyed-out)
    Request for manufacturer's access to DB ?
    Status of DM request?
    Status of DM (PW) request?

    Aside,  I did also locate the Italy - Local Network Group (LNG), and have been posting there as well.

    Many thanks,

    John



    ------------------------------
    John Hartigan
    VP, QA/RA
    Rochester MN
    United States
    ------------------------------



  • 5.  RE: Register products in the Italian FABBRICANTEDM = MANUFACTURERDM

    Posted 24-Oct-2023 21:52

    Hi John

    I see what you mean about the URL. Looks like you're in an account management section. Have you tried this one?

    https://nsis-ids.sanita.it/nidp/idff/sso



    ------------------------------
    Anne LeBlanc
    United States
    ------------------------------



  • 6.  RE: Register products in the Italian FABBRICANTEDM = MANUFACTURERDM

    Posted 25-Oct-2023 05:37

    Hi John,

    I already replied in the LXG - Italy to your post. It seems you are in the section where you manage your account. Try to enter through the link provided by Anne. After entering your credentials, you should be able to access the entire NSIS database. The NSIS database is not a straightforward system and so if you face any issues ...let us know. Good luck!



    ------------------------------
    Carlo d'Alessandro
    Director, Quality and Regulatory
    Roma
    Italy
    ------------------------------