To ensure compliance of the Quality Management System, the Central Drugs Standard Control Organisation said, it is “imperative” 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 asked the manufacturers to do “timely reporting” of adverse events to the Materiovigilance Programme of India (MVPI).
The government mandates companies to carry out post-market surveillance (PMS) of medical devices with an aim to ensure the safety and performance of the 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,” said a circular issued by the drug regulator on Wednesday.
ET has seen the circular.
The health ministry earlier launched the MVPI with the objective to improve patient safety by monitoring, recording and analysing 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.
