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

Serious Adverse Event (SAE) Reporting Timelines

Definition of Serious Adverse Event (SAE) An adverse event that results in:

Death
Life-threatening condition
Permanent or severe disability
Hospitalization or prolonged hospitalization
Birth defects or congenital abnormalities

Mandatory Reporting Timeline

Initial Report: Within 14 days of becoming aware of the SAE
Detailed Report: Within 30 days with complete information including investigation findings
Follow-up Information: Submitted as soon as available, with no defined deadline

Expedited Reporting (24-48 hours) Certain high-risk scenarios may trigger expedited reporting requests by CDSCO, such as:

Multiple deaths or serious injuries from the same batch
Product recalls or field safety notices
Device failures affecting critical patient care

Documentation Requirements Reports must include: device identification, patient demographics, event description, outcome, causality assessment, and corrective actions taken.

Non-Compliance Consequences Failure to report SAEs within prescribed timelines may result in regulatory action including warning letters, suspension of manufacturing license, or import ban.