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

SUGAM Portal – Medical Device Vigilance Reporting System

Overview The SUGAM (Streamlined Guidance And Monitoring) portal is the centralized online platform for all post-market vigilance reporting in India, managed by CDSCO. It replaced legacy paper-based reporting systems.

Access and Registration

Manufacturers and importers must register and obtain login credentials
Healthcare facilities can report independently or via manufacturer designation
Individual practitioners and patients can submit reports via dedicated channels

Reporting Process via SUGAM

Log in with credentials
Complete the adverse event form with all required fields
Attach supporting documentation (medical records, photos, investigation reports)
Submit electronically
Receive submission confirmation with reference number

Required Information

Device identification (name, batch, serial number, manufacturer details)
Patient information (age, gender, medical history)
Event description and timeline
Severity assessment
Suspected cause and contributing factors
Remedial actions taken
Reporter contact details

Benefits of SUGAM

Real-time submission and tracking
Automatic timestamping of reports
Reduced processing delays
Integrated alert and signal detection
Transparent audit trail

Technical Support For SUGAM portal issues, contact CDSCO Pharmacovigilance Division or check the official SUGAM help portal.