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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 CDSCO through the SUGAM portal (sugam.cdsco.gov.in) or directly to the DCGI/CDSCO with supporting clinical justification, ethics committee approval (where required), and manufacturer authorization letters.

Official source: Medical Devices Rules 2017; CDSCO

Applications should be submitted to the DCGI's office through the SUGAM portal (sugam.cdsco.gov.in) or by direct submission, including: (1) completed application form; (2) clinical case summary and justification; (3) proof that no licensed alternative exists in India; (4) overseas regulatory approval documentation; (5) ethics committee approval or waiver; (6) manufacturer's letter of support; (7) device specifications and safety data. Approval timelines typically range from 2–4 weeks depending on completeness of submission. Contact the CDSCO Medical Devices Division for specific guidance on your case.