This is a requirement under the Materiovigilance Programme of India which was launched in 2015 to monitor quality and safety of medical devices in India
The Central Drugs and Standards Control Organisation (CDSCO) has reminded medical devices manufacturers that they are mandated to self report adverse events related to these devices.
Reminding the companies of their obligation under the Materiovigilance Programme of India which was launched in 2015 to monitor quality and safety of medical devices in India, the CDSCO has said that the appropriate platform should be used for this reporting. “As the MVPI is an important programme for the reporting of adverse events, coordinated analysis etc related to the medical devices, including in vitro diagnostic devices, therefore it is suggested that all the licence holder should also use the MVPI platform for the reporting of any adverse events/serious adverse events associated with the device to enhance the procedure for identifying risk associated with medical devices,” reads the circular.
The circular, according to sources in the organisation, is aimed at bolstering the post marketing surveillance of medical devices.The nodal agency for the implementation of the MVPI is the Indian Pharmacopoeia Commission.
“The Materiovigilance Programme of India, launched by the Ministry of health and family welfare, Government of India 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 individual diagnostics by healthcare professionals or patients/users and suggesting regulatory bodies for appropriate action with the sole intention of improving patient safety…. Apart from healthcare professionals/general public/users/patients, the medical devices industries are one of the major stakeholders of MVPI, their participation needs to be encouraged to make significant impact in the outcome,” the circular adds.
