Constitution of Medical Device related Adverse Event Committee in each Medical College
The National Medical Commission (NMC) public notice, dated July 13, 2025, addresses the monitoring, assessment, and prevention of adverse events associated with medical devices through the constitution of a Medical Device related Adverse Event Committee (MDAEC) in each medical college.
Here’s a breakdown of the advisory:
Intent of the Advisory:
The core intent of this advisory is to enhance patient safety and improve the quality of healthcare delivery by systematically collecting, analyzing, and responding to adverse events related to medical devices. It acknowledges that medical devices are crucial in modern healthcare but can cause harm, necessitating a robust monitoring system. The advisory emphasizes the integration of medical colleges into the Materiovigilance Programme of India (MvPI), launched in 2015 by the Ministry of Health and Family Welfare (MoHFW), to monitor these adverse events and risks nationwide. This program aims to provide data to the Central Drugs Standard Control Organization (CDSCO) to support regulatory action and guide improvements in clinical practice.
Role of Medical Colleges:
Medical colleges are identified as ideal hubs for Materiovigilance due to their diverse patient populations and access to advanced healthcare technologies.
The advisory outlines several strategic advantages for medical colleges becoming a Medical Device Adverse Events Monitoring Centre (MDMC), including:
Academic Recognition: Enhancing the institution’s stature as a contributor to national public health and regulatory science.
Professional Development: Providing faculty and students hands-on exposure to post-market surveillance, risk assessment, and patient safety.
Infrastructure Enhancement: Gaining access to MvPI resources, training modules, and national-level collaboration.
Policy Influence: Offering opportunities to contribute to evidence-based recommendations and medical
device regulations.
Patient Safety: Ensuring early detection and response to device malfunctions, directly improving clinical outcomes.
Key Directives for Medical Colleges:
The advisory mandates the following actions for all medical institutions:
Establishment of MDAEC: Each medical institution is advised to set up a committee to monitor adverse events related to medical devices.
Registration with IPC: This committee must be registered with the Indian Pharmacopoeia Commission (IPC). The enrollment form is available on the IPC website.
Website Disclosure: The medical institution’s website must indicate the name of the Coordinator/Convenor and additional members of the committee.
Chairperson: The Medical Superintendent will ordinarily be the Chairperson of this committee.
Registration Date: The website should also indicate the date of MDAEC registration.
Pharmacovigilance Committee Update: Institutions are also reminded to update the names of Pharmacovigilance Committee members on their website.
Timeline: This process has to be completed before July 31, 2025.
