The National Medical Commission (NMC) has issued a public notice mandating the establishment of a “Medical Device related Adverse Event Committee” in every medical college across India. This directive is a step towards enhancing patient safety by systematically monitoring, assessing, and preventing adverse events associated with medical devices. This public notice was issued on July 13, 2025.
The move comes in recognition of medical devices’ indispensable role in modern healthcare and the increasing need for a robust system to track incidents causing patient harm. The Ministry of Health and Family Welfare (MoHFW) had previously launched the Materiovigilance Programme of India (MvPI) in 2015, coordinated by the Indian Pharmacopeia Commission (IPC), to monitor adverse events and risks linked to medical devices nationwide. The MvPI operates through a network of Medical Device Adverse Events Monitoring Centres (MDMCs) in hospitals and medical colleges, providing data to the Central Drugs Standard Control Organization (CDSCO) for regulatory action and clinical practice improvements.
Medical colleges are considered ideal hubs for Materiovigilance due to their diverse patient populations and access to advanced healthcare technologies. Becoming an MDMC offers several advantages, including academic recognition, professional development for faculty and students in post-market surveillance, access to MvPI resources and training, opportunities to influence policy, and most importantly, direct contributions to patient safety through early detection and response to device malfunctions.
Key Directives for Medical Colleges:
- Establishment of Committee: All medical institutions are advised to set up a dedicated committee to monitor adverse events related to medical devices.
- Registration with IPC: Each newly formed committee must be registered with the Indian Pharmacopoeia Commission (IPC). The registration/enrolment form is available on the IPC website
- Website Disclosure: The official website of every medical institution must clearly indicate the name of the Coordinator/Convenor of this new committee, along with any additional members. The Medical Superintendent will typically chair this committee. The website must also display the date of registration of the Medical Device Adverse Event Committee (MDAEC).
- Pharmacovigilance Committee Update: Institutions are also reminded to update the names of their Pharmacovigilance Committee members on their websites.
Medical colleges are instructed to complete these processes, including updating Pharmacovigilance Committee details, before July 31, 2025. This initiative is expected to significantly strengthen the monitoring and prevention of medical device-related adverse events, thereby enhancing overall patient safety and quality of healthcare delivery across the country.