Skip to main content

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

Key Protocol Elements​

A clinical investigation protocol for medical devices must include:

  • Study objectives (primary and secondary endpoints)
  • Detailed device description and its intended use
  • Patient population definition, inclusion/exclusion criteria
  • Study design (e.g., RCT, single-arm, non-comparative)
  • Safety and efficacy assessment methods
  • Statistical analysis plan with justified sample size
  • Interim analysis rules (if applicable)
  • Safety monitoring and stopping rules
  • Data management and quality assurance procedures
  • Insurance/compensation arrangements for study participants
  • Timeline and milestones

CDSCO expects protocols to follow good clinical practice (GCP) principles. Protocols adapted from international studies should be justified for applicability to the Indian patient population.