The Drugs Controller General of India (DCGI) has called for timely reporting of adverse events related to medical devices and directed all medical device licence holders and manufacturers to report any adverse events related to life-saving medical equipment on the government’s Materiovigilance Programme of India (MvPI) platform stating that the move is vital to mitigate risks and safeguard public health.
In its circular issued this week the top drug regulator said that the post-market surveillance (PMS) of medical devices is one of the important aspects to ensure safety and performance of the medical devices.
“PMS supports identifying and addressing 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 risks and safeguard public health,” it said.
