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  • 1.  India - CDSCO

    Posted 31-Mar-2020 10:29
    Does anyone have or know where I can find a template for:

    Central Drugs Standard Control Organization (CDSCO), essential safety and performance principles

    Much appreciated.

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    Valerie Followell
    Consultant
    Skokie IL
    United States
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  • 2.  RE: India - CDSCO

    Posted 01-Apr-2020 01:16
      |   view attached
    Hi Valerie, 

    I have attached an officially approved document released by the Govt. of India on the Essential principles of safety and performance of medical devices. i believe you can make your template based on these requirements. I am not sure if a template is available as yet. 

    Best regards
    Sathya

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    Sathya T N
    Regulatory Toxicologist
    ------------------------------

    Attachment(s)

    pdf
    05-10-18-Indiaprinciples.pdf   8.07 MB 1 version


  • 3.  RE: India - CDSCO

    Posted 01-Apr-2020 02:46
    I presume you are asking about the 2018 medical device guidance, though I would not say there is a "template." These summary points immediately below were taken from CDSCO as published in the draft for comment in August 2017 and subsequently approved by the DCG (India) on 19 April 2018. The full text version is found at the link from FDANews further below:

    Seven CDSCO Essential Principles
    The CDSCO's seven Essential Principles that would be applicable to all devices under the Medical Device Rules, 2017 include:

    • A device's manufacture and design will ensure that it performs as intended without compromising patient or user safety.
    • Device design and manufacturing solutions should conform to state-of-the-art safety and risk-reduction principles.
    • A device's design, production, and packaging should be suitable for its intended purpose under normal conditions of use.
    • The safety and performance of a device should not be compromised by the stresses that occur during normal use.
    • Transport and storage conditions should not adversely impact a device's characteristics or performance.
    • A manufacturer should minimize all "known and foreseeable risks, and any undesirable effects" to optimize the benefits of using the device under normal conditions.
    • A device requires clinical evidence appropriate for its particular intended use and classification to show compliance with essential principles.

    Along with the seven major principles for medical devices and IVDs listed above, the CDSCO document also addresses issues including chemical, physical, and biological properties; infection and contamination risk mitigation; combination products; and medical devices containing biological materials.

    FDANews kindly made available the full text copy of the approved document at https://www.fdanews.com/ext/resources/files/2018/05-10-18-Indiaprinciples.pdf?1525967416, although it should be findable on the CDSCO website as well. For the online application instructions, see: https://cdscomdonline.gov.in/NewMedDev/resources/app_srv/NMD/global/pdf/MD_User_Manual_Guidance.pdf

    Cdscomdonline remove preview
    View this on Cdscomdonline >

     

    Fdanews remove preview
    View this on Fdanews >

     

    If you are looking for the CDSCO device submissions checklist, it is one part (Form MD-3 is one of them, you have to choose between MD and IVD types) of a long series of forms, which you may still find at MD - Medical Devices
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    MD - Medical Devices
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    I hope this was helpful.

    Best regards,

    Jan

    ------------------------------
    Jan S. Peterson, MS, CCRA, RAC, ASQ CBA, ACRP-CP
    Consultant and
    VP of Regulatory Affairs and Quality
    Global Regulatory Partners, Inc.
    United States
    ------------------------------



  • 4.  RE: India - CDSCO

    Posted 01-Apr-2020 09:21
    Thanks Jan.  As I mentioned to Sathya the distributor in India was asking for the India version of an ERC.  This is helpful to know what is appropriate to provide.

    ------------------------------
    Valerie Followell
    Consultant
    Skokie IL
    United States
    ------------------------------



  • 5.  RE: India - CDSCO

    Posted 01-Apr-2020 11:58
    Hi Valerie,

    In case, your distributor is registering device for import license, EU ERC will suffice under 'device file'. Distributor as importer, don;t have to submit India version of an ERC.

    Hope it helps.

    Best Regards-
    Sharad

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    Sharad Mi. Shukla, RAC
    RA Leader
    GE Healthcare
    Bangalore, Karnataka
    India
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