Schedule 7 Vigilance

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 7 of the Medical Devices Rules 2017 establishes the Vigilance framework for post-market safety monitoring. Key requirements include: mandatory adverse event reporting to CDSCO within specified timelines, establishment of pharmacovigilance systems, periodic safety update reports (PSURs), management of field safety notices and recalls, investigation of reported incidents, and maintenance of vigilance records. Manufacturers and importers must report serious adverse events, deaths, and safety-related incidents to enable ongoing risk management.