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DCGI-ICMR Guidelines: Manufacturer, supplier of

    https://medicaldialogues.in/news/industry/medical-devices/dcgi-icmr-guidelines-manufacturer-supplier-of-covid-19-diagnostic-kits-can-directly-apply-for-dcgi-approval-details-66540
    As per the guidelines, the manufacturers and suppliers of US Food and Drug Administration (USFDA) approved RT-PCR kits, RNA extraction kits and viral transport medium (VTM), rapid antibody test, ELISA and CLIA kits can directly apply for DCGI …

Medical device & diagnostics - Central Drugs Standard …

    https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/Medical-Device-Diagnostics/
    6.Grant of license to Import investigational medical device by Government …

Latest Circulars, Notices & Guidelines: …

    https://thehealthmaster.com/2021/04/18/latest-circulars-notices-guidelines-cdsco-dcgi/
    DCGI-notice-dt-16-03-2022-Classification-of-Medical-Device-pertaining-to-General-Hospital-Orthopaedic-instruments-under-the-provisions-of-Medical-Devices …

Regulations Needed to be Followed for Selling Medical Device

    https://www.iiprd.com/medical-devices-compliances-and-regulations-in-india/
    Medical devices and IVDs are controlled by the Drug Controller General of India (DCGI), which is part of the Ministry of Health and Family Welfare’s Central Drugs …



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