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  • 1.  License holder in India

    Posted 21-May-2020 07:18
    Hello All,

    Does anyone know the rules around who can hold device licenses in India?
    I've been receiving mixed messages - Some say it must be the importer, and multiple distributers can hold their own licenses. Others say an independent i.e 3rd party can hold the licenses and this can be separate from whoever is the distributer. 

    Appreciate the help!

    Many thanks,
    Holly

    ------------------------------
    Holly Cribbes
    Regulatoy Associate
    Dunfermline
    United Kingdom
    ------------------------------


  • 2.  RE: License holder in India

    Posted 22-May-2020 04:38
    Hello Holly,

    Different rules are applicablle, if anyone intends to manufacture device in India or get it imported and distributed in india. Also there have been major device rules change in 2017.
    Let me know specific query, I may suggest you accordingly.

    ------------------------------
    [Deepa] [Dasgupta, RAC] [Director]
    Director
    Hyderabad
    [India]
    ------------------------------



  • 3.  RE: License holder in India

    Posted 22-May-2020 10:49
    Hello Deepa,

    Many thanks for your reply. 

    The devices are manufactured in the UK, and imported into India. I'm looking to know who should be the licence holder. Can a 3rd party/ independent hold the licenses and then distributers can be appointed independent of the licence holder, or does the actual importer of the devices into India have to be the license holder?

    Appreciate your comments,
    Holly

    ------------------------------
    Holly Cribbes
    Regulatoy Associate
    Dunfermline
    United Kingdom
    ------------------------------



  • 4.  RE: License holder in India

    Posted 22-May-2020 12:00
    Hello holly,

    An authorised agent having licence to manufacture for sale or distribution or wholesale licence for sale or distribution under Indian rules, shall make an application for grant of import licence for medical device to the Central Licensing Authority through an identified online portal of the Ministry of Health and Family Welfare in the Central Government in certain Form (MD-14) for obtaining a licence.


    Hope it clarifies.


    Regards,

    Deepa Dasgupta, RAC

    Director- regulatory Affairs, 

    Hyderabad

    India