Chapter Vi Vigilance

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 VI establishes vigilance (adverse event monitoring) requirements for medical devices, including mandatory reporting of serious adverse events to CDSCO within specified timeframes (typically within 2 weeks of becoming aware of the event for serious cases). Manufacturers and importers must establish adverse event monitoring systems, investigate adverse events, and report findings within specified timeframes. Requirements include maintenance of vigilance records and implementation of corrective actions.

Chapter VI establishes pharmacovigilance requirements for medical devices, including mandatory reporting of serious adverse events to CDSCO. Manufacturers and importers must establish adverse event monitoring systems, investigate adverse events, and report findings within specified timeframes. Requirements include maintenance of vigilance records and implementation of corrective actions.