DCGI calls for strict reporting of side-effects related to medical devices

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.

The MvPI was launched by the Health Ministry with the objective to improve Indian 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 with the sole intention of improving patient safety.

“Mvpl is an important program for reporting of adverse events, coordinated analysis etc related to the medical devices including in-vitro diagnostic devices, therefore it is suggested that all the license holder should also use the MvPI platform for reporting of any adverse events/serious adverse events associated with the devices,” the communication said.

Currently in India 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 for marketing of the devices in the country.