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Clinical Investigation

Clinical investigations for medical devices in India are governed by Chapter V of MDR 2017 (Rules 37–45) and the New Drugs and Clinical Trials Rules 2019.

When clinical data is required​

  • Novel devices without a reference authority approval;
  • Class C and D devices (may be required even with reference approval);
  • Devices where bridging is not sufficient.

CDSCO permission​

Form MD-24 (clinical investigation permission) or Form MD-28 (amendment) is submitted via SUGAM, along with a clinical investigation protocol reviewed and approved by a CDSCO-recognised Ethics Committee.

Official source: Medical Devices Rules 2017, Chapter V; ND&CT Rules 2019; CDSCO

Form MD-24 Submission Requirements and Timeline​

Form MD-24 requires:

  • Completed and signed Form MD-24
  • Clinical investigation protocol (EC-approved)
  • Investigator's CV and qualifications
  • Quality Overall Summary and technical documentation
  • Risk analysis
  • Insurance or indemnity details
  • For new drugs/devices: Reference authority approval (if available)

Submission is made via the CDSCO SUGAM portal. Expected review time is 30 days; CDSCO may issue deficiency letters requiring clarifications or additional data. Form MD-28 is used to amend an approved protocol (e.g., investigator change, protocol revision).