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India Will Require All Lower-Risk Class A Devices to be Registered Online

  • 1.  India Will Require All Lower-Risk Class A Devices to be Registered Online

    Posted 09-Nov-2022 16:26
    By this past October, device manufacturers and importers of Class A medical devices are required to register their products via an online portal. The manufacturer or importer will also need to confirm that their device meets the requirements of the essential principles checklist and is non-sterile and non-measuring. Information on the Class A device to be uploaded onto the online system includes the generic name, brand name, intended use, shelf life, etc. After self-certifying with the online system, a registration number will be issued. In addition, the manufacturer or importer will need to keep good records of the manufacture, import, sales, and distribution of such products or risk suspension or cancelation of their registration number.

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    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda, MD
    www.pacificbridgemedical.com
    contact@pacificbridgemedical.com
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