CDSCO calls for timely reporting of adverse events related to medical devices to MvPI

The Central Drugs Standard Control Organisation (CDSCO) has requested stakeholders to take appropriate action for timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI), in the backdrop of shifting the segment to licensing regime. All the 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, at present, with mandatory license or approval is required for the import or manufacturing for marketing of the devices in the country. The devices have been classified as Class A, B, C and D and all the classes were brought under the licensing regime in the last two years. The licenses are issued under these rules with certain conditions, to ensure the quality, safety and performance of medical devices available in the market, as well as to ensure compliance of the quality management system. It is also imperative 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, said the CDSCO in a latest circular. 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 identification and addressing of 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. “As the MvPI is an important programme 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 holders should also use the MvPI platform for reporting of any Adverse events/Serious adverse events associated with the devices to enhance the procedure for identifying risk associated with medical devices,” said the Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi. “…you are requested to take appropriate action for timely reporting of adverse events related to medical devices to MvPI. Guidance documents developed for effective utilisation of MvPI is available on IPC website…,” he added. For any training required to enhance understanding and proficiency in adverse event reporting processes, the industry or the regulators may contact the Indian Pharmacopoeia Commission (IPC) through its email ID, said the regulator. The MvPI has been launched by the Union Ministry of Health and Family Welfare 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 or users and suggesting regulatory bodies for appropriate action with the sole intention of improving patient safety. IPC has been entrusted with National Coordination Centre responsibilities related to MvPI. Apart from healthcare professionals, general public users, patients, the medical devices industries are one of the major stakeholders of MvPI, and their participation needs to be encouraged to make a significant impact in the outcome, said the regulator.

Source : 1