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Compassionate Use — CDSCO Permission

CDSCO may grant permission for the import and use of an unlicensed medical device on a compassionate use / named-patient basis where:

  • No licensed alternative is available in India;
  • The device is needed to treat a life-threatening or seriously debilitating condition;
  • The device is available overseas with regulatory approval.

Applications are submitted to the DCGI/CDSCO with supporting clinical justification and, where required, ethics committee approval.

Official source: Medical Devices Rules 2017; CDSCO