The Central Drugs Standard Control Organisation (CDSCO) on May 15, 2024, requested the Medical Device License Holders to Report Adverse Events On the MvPI Platform.
The following has been stated:
• It has been stated that all medical device licence holders establish robust systems and processes for the timely identification, documentation, and reporting of adverse events associated with medical devices.
• It has been stated that the timely reporting of Adverse events allows for the identification of unidentifiable risks, analysing the frequency of already identified risks and enabling the manufacturers and regulatory authorities to take appropriate measures to mitigate these risks and safeguard public health.
• It has requested that appropriate action for timely reporting of adverse events related to medical devices to MvPI. Guidance documents developed for the effective utilization of MvPI is available on the IPC website (https://www.ipc.gov.in.). If any training is required to enhance understanding and proficiency in adverse event reporting processes, you may contact to mvpi¬[email protected].
[Notification No MED-12/30/2024-eoffice]
