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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

Add the following section after 'CDSCO permission':

CDSCO-Recognised Ethics Committees

Not all institutional ethics committees are recognised by CDSCO for device clinical investigations. An ethics committee must be:

  • Registered with CDSCO (list available on CDSCO website)
  • Constitute at least 5 members including lay representatives
  • Have prior experience reviewing medical device protocols

Typical EC review timelines range from 4–8 weeks depending on protocol complexity. It is advisable to select an experienced, CDSCO-recognised EC early in the planning phase.