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

Periodic Safety Update Report (PSUR)

A PSUR is a comprehensive safety report submitted at regular intervals to document the ongoing safety profile of a marketed medical device. In India, PSURs are required under the Medical Devices Rules 2017 for Class C and D devices.