Regulatory Open Forum

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  • 1.  Regulatory approval

    Posted 28-Sep-2021 05:48
    Hello to All,

    Good day to everyone!

    Anybody from Medical Device in India, I need guidance regarding all the regulatory guidelines needs to be implemented for the start up company, as I do not want to miss any of the regulations/ guidelines and have to start the process as early for the documentation and Certification and it will be grateful if anyone can also share the requirements for MDR17 certification. 

    Also, in June 2021 we have submit the list of item, turnover and MRP to CDSCO, I want to confirm the frequency of its submission? as I have checked it is written annually is tat correct?

    kindly enlighten me on the said queries.

    Regards
    Shivani




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    Shivani Chawda
    Quality Assurance Executive
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