NMC directs Medical Colleges to set up Panel to Monitor Medical Device Adverse Events

New Delhi: Highlighting the need to ensure the safety of medical devices, the National Medical Commission (NMC) has asked all medical institutes to set up a Committee to monitor the adverse events related to medical devices.

Issuing a public notice in this regard on 13.07.2025, the Commission further clarified that each medical institute should register such Committees with the Indian Pharmacopeia Commission. NMC provided a link to access the registration/enrolment form from the Website of the Indian Pharmacopeia Commission:

Further, the Commission added that the website of all medical institutes should indicate the name of the Coordinator/Convenor of the committee and additional members, if any. Ordinarily, this committee will be chaired by the Medical Superiendent and the website of the medical college should also indicate the date of registration of the MDAEC (medical devices adverse effect committee).

"Institutions are also reminded to update the Pharmacovigilance Committee members’ names in the website of the institution. This process may be completed before 31.07.2025," NMC added in the notice.

NMC mentioned in the notice how medical devices have become an indispensable part of modern healthcare, contributing significantly to the diagnosis, treatment, and management of diseases. Various incidents involving medical devices causing harm to the patients has created the need of a system to monitor these events and take necessary actions to prevent these from happening again, mentioned the Commission.

Materiovigilance Programme of India (MvPI):

The Commission highlighted how, in response to this, the Ministry of Health and Family Welfare launched the Materiovigilance Programme of India (MvPI) in 2015 at the Indian Pharmacopoeia Commission, to monitor adverse events and risks associated with medical devices used across the country.

This national initiative was designed to systematically collect, analyse, and respond to adverse events associated with medical devices and ensure better patient safety and quality healthcare delivery. The program is coordinated by the IPC and operates through a growing network of Medical Device Adverse Events Monitoring Centres (MDMCs) in hospitals and medical colleges.

"The Materiovigilance Programme of India (MvPI) is a national initiative aimed at ensuring the safety of medical devices across their lifecycle. MvPI enhances device safety through systematic reporting and analysis of adverse events, providing data to CDSCO to support regulatory action and guide improvements in clinical practice," NMC added in the notice.

NMC pointed out that the Medical Devices Rules, 2017, regulate the import, manufacturing, sale and distribution of medical devices in India, including post-market surveillance of a medical device.

Advantages of Becoming a Medical Device Adverse Events Monitoring Centre (MDMC):

The Commission also listed down the advantages for the medical colleges to serve as the Medical Device Adverse Events Monitoring Centre. It opined that the medical colleges serve as ideal hubs for Materiovigilance due to their diverse patient populations and access to advanced healthcare technologies.

According to NMC, becoming an MDMC offers the following strategic advantages:

Academic Recognition: Participation enhances the institution’s stature as a contributor to national public health and regulatory science.

Professional Development: Provides faculty and students hands-on exposure to post-market surveillance, risk assessment, and patient safety.

Infrastructure Enhancement: Access to MvPI resources, training modules, and national-level collaboration.

Policy Influence: Opportunities to contribute to evidence-based recommendations and medical device regulations.

Patient Safety: Ensures early detection and response to device malfunctions, directly improving clinical outcomes.

To view the NMC notice, click on the link below:

https://medicaldialogues.in/pdf_upload/nmc-monitoring-assessing-and-preventing-adverse-events-associated-with-medical-devices-constitution-of-medical-device-related-adverse-event-committee-in-each-medical-college-294507.pdf

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