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

Expand this section as follows:

When Clinical Data Required

Clinical investigations are mandated in these scenarios:

  1. Novel Devices Without Reference Authority Approval

    • No approved equivalent device exists in USA, EU, Japan, or other reference jurisdictions
    • CDSCO requires clinical evidence of safety and performance

  2. Class C and D Devices

    • Clinical data is typically required regardless of reference approval status
    • Reference approval may reduce data requirements but does not eliminate them
    • Exception: Extensive post-market surveillance data may support waiver requests

  3. Devices Where Bridging is Insufficient

    • Design modifications significantly alter device performance or safety profile
    • Intended use differs materially from reference-approved indications
    • Target patient population has distinct demographic or genetic characteristics
    • Reference clinical data is limited, outdated, or does not address specific safety concerns

Class A and B devices: Clinical investigations are typically not required if adequate technical documentation and reference approval (where available) support the regulatory submission.