Centre's New MvPI Guidance Tells Hospitals To Step Up Surveillance Of Critical Medical Devices

New Delhi : The Centre has called for a more structured and proactive system to monitor the safety of medical devices in hospitals, with new guidelines asking healthcare facilities to routinely track critical devices, designate departmental nodal officers and promptly report malfunctions, near-misses, incidents and adverse events.

 

The “Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Devices Related Incidents/Adverse Events – Materiovigilance Programme of India (MvPI), 2026”, released by the Health Ministry in New Delhi on Monday, seeks to strengthen India’s post-market surveillance system, as hospitals increasingly use sophisticated medical technologies, including connected, artificial intelligence-enabled and software-driven devices.

The Materiovigilance Programme of India (MvPI) was launched in 2015 to monitor the safety of medical devices after they enter the market. It seeks to identify, assess and prevent adverse events and other safety concerns associated with medical devices and generate evidence that can support regulatory action.

 

The programme is coordinated nationally through the National Coordinating Centre-MvPI at the Indian Pharmacopoeia Commission (IPC). Medical Device Monitoring Centres (MDMCs), hospitals and healthcare professionals form part of the reporting network.

 

“Unlike the safety monitoring of medicines, medical-device surveillance has to account for a wider range of potential problems. Risks can arise from the design or materials of a device, manufacturing defects, software failures, inadequate maintenance, improper use, insufficient training or interactions between different devices,” said Dr Tamorish Kole, a renowned expert from India’s health sector and past president of Asian Society of Emergency Medicine to ETV Bharat.

 

The new guidance, prepared by IPC in collaboration with the World Health Organisation (WHO), India and other partner organisations, seeks to make hospitals an active part of this surveillance system.

 

A key change proposed by the guidelines is greater emphasis on active surveillance of high-risk devices.

Hospitals have been advised to maintain a list of critical devices used in settings such as intensive care units, operation theatres, cardiology, neurosurgery, oncology and emergency care. These may include invasive, implantable or life-supporting devices where malfunction can have serious consequences.

 

Such devices must be monitored routinely — weekly or monthly depending on their use and risk profile — and the list must be displayed prominently in relevant departments, the guidelines stated.

 

Every department undertaking active surveillance is also expected to designate a nodal officer responsible for monitoring device performance, sensitising staff about potential risks and ensuring timely reporting.

The objective, however, is not simply to increase the number of reports but to detect safety signals early.

 

“Reports reaching NCC-MvPI will be assessed for the seriousness and frequency of incidents, consistency of reported events and possible causal links between a device and an adverse event. Where evidence indicates a credible safety concern, the findings can be referred to the Central Drugs Standard Control Organisation (CDSCO) for consideration of regulatory action,” a senior Health Ministry official said.

 

Depending on the evidence, this could lead to further investigation, requests for technical information from manufacturers, safety alerts, corrective or preventive measures, enhanced post-market surveillance, or product recall or withdrawal, the official added.

 

Significantly, the guidance also allows safety alerts to be issued even when causality has not yet been conclusively established, enabling hospitals to increase vigilance and look for similar incidents while scientific assessment continues.

 

The framework also proposes baseline studies to identify the availability and use in India of devices that have been subject to recalls, Field Safety Corrective Actions or Field Safety Notices in India or overseas.

 

“Hospitals may be asked to provide details such as manufacturer, importer, model, batch or lot number, number of devices in use, patient exposure and any associated adverse events. Regulatory actions by authorities such as the US FDA, European regulators, Swissmedic and Australia's Therapeutic Goods Administration could feed into India’s surveillance efforts,” the guidelines stated.

 

The timing of the guidance is significant as medical technology moves rapidly towards AI-enabled systems, connected devices and Software as a Medical Device (SaMD).