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.

Reporting timelines vary by severity: serious adverse events and deaths must be reported to CDSCO within 14 calendar days of becoming aware of the event. For devices with periodic safety update reports (PSURs), manufacturers must submit reports at intervals defined by CDSCO, typically annually for marketed devices or as specified in the product approval conditions. Non-serious adverse events should be documented and reported in the next periodic submission.