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  • 1.  INDIAN Authorized Agents

    Posted 08-Jan-2022 04:46
    Hi, in order to get a medical device registered in India under a voluntary registration scheme, can anyone advise if
    1) an Indian authorized agent can function as only the "registrant", helping a foreign company (located outside of India) register their medical device and get a registration number without being an importer, ie. the "registrant" and importer are different parties? or the party registering the product has to be the importer (same party)? 
    2) are the documents for application of a voluntary registration number the same as that for the import license? 
    2) can there be multiple importers from different parts of India applying for the import license of one medical device at the same time? 
    3) can a distributor be an importer holding the import license to the medical product? 

    Thanks in advance to those able to help answer the questions!
    Regards,
    Therese

    ------------------------------
    Hong-May Sim
    Singapore
    Singapore
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  • 2.  RE: INDIAN Authorized Agents

    Posted 09-Jan-2022 23:03
      |   view attached
    Hi Therese,

    I would like to answer your questions. Here the first thing is that only those products are going to register under Voluntary Registration (VR) which was not already been regulated in India. 
    1. Yes, the product registrant and importer should be the same. 
    2. No, the documents required are minimum for VR. Only ISO 13485 and FSC/CFS/CFG is required with product description.
    3. Yes, they can.
    4. Yes
    This was a voluntary registration process (now we are in a mandatory regime from October 1st, 2021) where Indian Regulators want to prepare a database for their records, to understand all the non-regulated devices. From September 2023 you need an Import license for Class A and B Devices while from September 2024 you need Import License for Class C and D Devices. 

    Feel free to contact me for any further details.

    Regards
    Priyank Srivastava (Mr.)

    ------------------------------
    Priyank Srivastava
    Mr.
    Ghaziabad
    India
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    Attachment(s)

    pdf
    Gsr102eRegistration of certain medical devices.pdf   1.16 MB 1 version
    Original Message


  • 3.  RE: INDIAN Authorized Agents

    Posted 10-Jan-2022 20:56
    Hi Therese:

    The simpler answer is yes for most of your questions; allow me to address them one by one:

    1. Yes, the registering party does not need to be the same as the importer party
    2. Yes, for the most part but depending upon the Device classification (per India's rules), there are additional requirements that ought to be met, one of which is the Plant Master file (similar to Taiwan's QSD process if you are familiar with it).
    3. I am not 100% sure it is possible to have multiple import licenses for the same medical device
    4. Yes, distributors can act as importers as well. 

    If you need expert advice I will recommend the following firm, they are reliable, knowledgeable and easy to work with: 

    Good luck!

    Claudia



    Original Message


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