Use MvPI platform for reporting any adverse events linked to medical devices: CDSCO

New Delhi: With an aim to enhance the procedure for identifying the risk associated with Medical Devices, through a recent notification, the Ministry of Health and Family Welfare, Directorate General of Health Services, Central Drugs Standard Control Organisation, has suggested that all medical device license holder should use the Materiovigilance Programme of India (MvPI) platform for reporting of any adverse events/serious adverse events associated with the devices.

Furthermore, the notice added that all medical device license holders are requested to take appropriate action for timely reporting of adverse events related to medical devices to MvPI.

"Guidance documents developed for effective utilization of MvPI are available on IPC website (https://www.ipc.gov.in.). If any training is required to enhance understanding and proficiency in adverse event reporting processes, you may please contact mvpi­ ipc@gov.in." notice added.

Currently, all Medical Devices including In-vitro diagnostic medical devices have come under the regulation under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017. A License/ approval is required for the import/manufacture of marketing of the devices in the country. The licenses are issued under the said rules with certain conditions, to ensure the quality, safety, and performance of Medical Devices available in the market, as well as to ensure compliance with the Quality Management System.

The circular also highlighted that all medical device license holders establish robust systems and processes for the timely identification, documentation, and reporting of adverse events associated with medical devices.

In continuation with the above, it noted, "The Post-market surveillance (PMS) of medical devices one of the important aspects to ensure safety and performance of the medical devices.PMS supports to identify and address any potential risk or adverse event associated with the medical device. Timely reporting of the Adverse events allows for the identification of unidentifiable risks, analysing frequency of already identified risks and enabling the manufacturers and regulatory authorities to take appropriate measures to mitigate these risks and safeguard public health."

The Materiovigilance Programme of India (MvPI) was launched by the Ministry of Health and Family Welfare, Government of India with the objective of improving Indian patient safety by monitoring, recording, and analyzing the root cause of adverse events or risks associated with the use of medical devices including in­ vitro diagnostics by healthcare professionals or patients/users and suggesting regulatory bodies for appropriate action with the sole intention of improving patient safety.

Indian Pharmacopeia Commission (IPC) has been entrusted with National Coordination Centre responsibilities related to the Materiovigilance Programme of India (MvPI).

Apart from healthcare professionals/general public/users/patients, the Medical devices industry is one of the major stakeholders of MvPI, their participation needs to be encouraged to make a significant impact on the outcome.

In line with the above, the notice stated,

"As the MvPI is an important program for reporting adverse events, coordinated analysis, etc related to Medical Devices including In-vitro diagnostic devices, therefore it is suggested that all the license holders should also use the MvPI platform for reporting any Adverse events/Serious adverse events associated with the devices to enhance the procedure for identifying risk associated with Medical Devices."

Moreover, the notice suggested to all medical device license holders,

"In view of the above, you are requested to take 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 please contact mvpi­ ipc@gov.in."

To view the official notice, click the link below:

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