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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 CDSCO through the SUGAM portal (sugam.cdsco.gov.in) or directly to the DCGI's office 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.