CDSCO Urges Medical Devices Stakeholders to Report Adverse Events to MvPI

The MvPI plays a vital role in reporting and coordinating analysis of adverse medical device-related events, including in-vitro diagnostic devices.

The Central Drugs Standard Control Organisation (CDSCO) has issued a directive urging stakeholders to ensure the timely reporting of adverse events related to medical devices to the Materiovigilance Programme of India (MvPI).

This comes in the context of transitioning the medical device segment to a licensing regime.

Under the current regulatory framework, all medical devices, including in-vitro diagnostic devices, are regulated by the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017.

The import or manufacture of these devices for marketing in India now requires mandatory licensing or approval. The devices are categorized into Class A, B, C, and D, with all classes being incorporated into the licensing regime over the past two years.

Licenses issued under these rules come with specific conditions designed to ensure the quality, safety, and performance of medical devices available in the market.

Additionally, these conditions enforce compliance with quality management systems. The CDSCO emphasized the importance of establishing robust systems and processes for the timely identification, documentation, and reporting of adverse events associated with medical devices.

According to the CDSCO, a “serious adverse event” is defined as an untoward medical occurrence that leads to:

1. Death; or

2. A serious deterioration in the health of the subject, resulting in:

   - A life-threatening illness or injury;

   - Permanent impairment of a body structure or function;

   - In-patient hospitalization or prolongation of existing hospitalization;

   - Medical or surgical intervention to prevent life-threatening illness, injury, or permanent impairment;

3. Foetal distress, fetal death, or a congenital abnormality or birth defect.

Post-market surveillance (PMS) of medical devices is critical in ensuring their safety and performance. PMS helps identify and address potential risks or adverse events associated with medical devices.

Timely reporting of these adverse events is crucial as it aids in identifying unrecognized risks, analyzing the frequency of known risks, and enabling manufacturers and regulatory authorities to take appropriate measures to mitigate these risks, thus safeguarding public health.

Utilizing the MvPI Platform

The MvPI plays a vital role in reporting and coordinating analysis of adverse medical device-related events, including in-vitro diagnostic devices.

Dr Rajeev Singh Raghuvanshi, DCGI, emphasized the importance of using the MvPI platform to report adverse events. He suggested that all license holders utilize this platform to enhance the procedure for identifying risks associated with medical devices.

“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,” Raghuvanshi stated.

The CDSCO also highlighted the availability of guidance documents developed to effectively utilize the MvPI, which can be accessed on the Indian Pharmacopoeia Commission (IPC) website.

The industry or regulatory bodies can email the IPC for training purposes to enhance their understanding and proficiency in adverse event reporting processes.

MvPI & Patient Safety

The MvPI was launched by the Union Ministry of Health and Family Welfare to improve patient safety in India.

The program focuses on monitoring, recording, and analyzing the root causes of adverse events or risks associated with the use of medical devices, including in-vitro diagnostics, by healthcare professionals, patients, and other users.

The insights gathered are used to suggest regulatory actions aimed at improving patient safety.

The IPC has been entrusted with the responsibilities of the National Coordination Centre for the MvPI.

The active participation of various stakeholders, including healthcare professionals, the general public, patients, and the medical device industry, is crucial for the success of the program.

The regulator emphasized the need to encourage participation from all these groups to impact the outcomes of the MvPI significantly.