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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

Scope and Application of NDCT Rules 2019

While medical device clinical investigations are primarily governed by MDR 2017 (Chapter V, Rules 37–45), the New Drugs and Clinical Trials Rules 2019 (NDCT Rules) provide supplementary requirements in the following areas:

  • Ethics Committee recognition and composition standards (partially overlap with MDR requirements)
  • Adverse event reporting and safety monitoring during investigations
  • Records retention and data integrity requirements
  • Investigator qualifications and responsibilities

In case of conflict between MDR 2017 and NDCT Rules 2019, MDR 2017 is the primary governing framework for devices. However, where NDCT Rules impose stricter standards, those should be followed.