Chapter V Clinical Investigation

This page summarises the key rules in this chapter of the Medical Devices Rules 2017 and links to the relevant primary source.

Official source: MDR 2017 — CDSCO

Chapter V establishes requirements for clinical investigations of medical devices, including approval from CDSCO and ethics committee clearance. Applications must include study protocol, investigator qualifications, informed consent forms, and safety monitoring plans. The process is governed by the New Drugs and Clinical Trials Rules 2019 for applicability to certain device investigations.