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Vigilance Reporting

India's Medical Device Vigilance Programme requires timely reporting of adverse events and periodic safety updates via the SUGAM portal.

See MDVP Overview for the full framework.

Official source: Medical Devices Rules 2017, Schedule 7; CDSCO

Reporting Obligations Overview

Reporting Obligations Overview

Who Must Report

  • Manufacturers (including importers for imported devices)
  • Authorized representatives
  • Healthcare facilities and hospitals
  • Individual healthcare professionals
  • Device users and patients

What Must Be Reported Adverse events (AEs) are unintended harmful occurrences associated with device use, including:

  • Serious injuries or deaths
  • Prolonged hospitalization
  • Device malfunctions affecting safety or performance
  • Near-misses with potential for harm

Reporting Timelines

  • Serious Adverse Events (SAEs): Within 14 days of awareness
  • Non-serious AEs: Within 30 days
  • Follow-up information: As soon as available

Reporting Channel All adverse event reports must be submitted via the SUGAM portal or directly to CDSCO Pharmacovigilance Division.

Manufacturer Responsibilities Manufacturers must establish and maintain an effective post-market surveillance system and designate a qualified individual responsible for adverse event management and trending.