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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

Clinical Data Waiver and Bridging Criteria​

Clinical Data Waivers

CDSCO may waive clinical investigation requirements if:

  • The device is approved and marketed in a reference authority jurisdiction (USA, EU, Japan, etc.)
  • The reference approval includes adequate clinical data demonstrating safety and effectiveness
  • The device specifications and intended use are identical to the reference-approved device
  • No new patient populations or use cases are proposed

Bridging Studies

A bridging study may be acceptable instead of a full clinical investigation if:

  • Reference approval exists but with limited clinical data
  • Genetic or demographic differences between study populations are minimal
  • The device has undergone minor design changes not affecting safety/performance
  • Adequate post-market surveillance data from the reference jurisdiction is available

CDSCO will not accept bridging or waivers for Class C and D devices without robust justification and supporting evidence.