Schedule 6 Clinical Investigation

This page provides an overview of this Schedule of the Medical Devices Rules 2017 and links to the official text.

Official source: MDR 2017 — CDSCO

Schedule 6 of the Medical Devices Rules 2017 sets out requirements for clinical investigations of medical devices in India. Key elements include: protocol development and ethical approval, investigator qualifications, informed consent procedures, adverse event monitoring and reporting, data integrity and record-keeping, clinical data analysis, and reporting timelines. Clinical investigations may be required for higher-risk devices, new technologies, or when non-clinical evidence is insufficient to demonstrate safety and performance.