CDSCO has issued a Circular re-iterating the mandate of reporting any suspected unexpected serious adverse events. All such reports are required to be submitted to the Materiovigilance Programme of India (MvPI).
For further training on adverse event reporting, please contact mvpi-ipc@gov.in. A Guidance Document on this matter has also been made available on the IPC website.
Background:
CDSCO emphasized the importance of robust systems for identifying, documenting, and reporting adverse events to ensure the safety and quality of medical devices. Post-market surveillance (PMS) is crucial for detecting and mitigating potential risks associated with these devices. License holders are urged to report adverse events via the MvPI platform to facilitate coordinated analysis and enhance risk identification.
The MvPI, launched by the Union Ministry of Health and Family Welfare, aims to improve patient safety by monitoring and analyzing adverse events related to medical devices.
A Copy of the Circular is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
