New Delhi: Hospitals nationwide have been asked to establish structured systems for monitoring and promptly reporting suspected adverse events linked to medical devices, including malfunctions, near-miss incidents and performance failures, under the updated Materiovigilance Programme of India (MvPI) guidelines.
The guidance document for hospitals in India for safety monitoring and reporting of medical devices related incidents/adverse events, Version 1.3, has been developed by the Indian Pharmacopoeia Commission (IPC) in collaboration with World Health Organization (WHO) India and other national stakeholders.
It seeks to strengthen systematic identification, documentation, assessment and reporting of medical device-related adverse events.
According to the document, all suspected Medical Device Adverse Events (MDAEs) should be reported promptly, irrespective of whether a definitive causal relationship between the medical device and the reported event has been established.
“Early reporting of suspected events facilitates timely assessment, investigation, signal detection, and implementation of appropriate corrective or preventive measures to enhance patient and user safety,” it stated.
Under the reporting framework, serious adverse events involving death or serious deterioration in health are to be reported to MvPI within 15 days, while non-serious adverse events that could potentially cause serious harm are to be reported within 30 days. Suspected unexpected serious adverse events are to be reported to the concerned licensing authority within 15 days.
The guidance document states that when there is uncertainty whether an incident should be reported, the preference should be to report it. It identifies device malfunction or deterioration, incorrect or out-of-specification test results, design flaws, labelling inaccuracies, serious public health threats and use errors among incidents that may warrant reporting.
Hospitals have also been asked to maintain complete records of device-related incidents, preventive maintenance logs, calibration records and root-cause analyses. “All significant or recurrent adverse events must undergo structured root cause analysis (RCA),” the document says, adding that hospitals should implement corrective and preventive actions and monitor their effectiveness.
The guidance calls for hospitals to designate a nodal officer or establish a Medical Device Adverse Event Monitoring Centre (MDMC), where applicable, and ensure regular training of clinical, nursing and biomedical staff to identify device malfunctions, failures and performance issues.
It also says healthcare professionals should remain vigilant for “any medical device malfunction, failure, abnormal performance, or unexpected patient outcome” during device use and ensure prompt reporting of suspected device-related incidents.
The framework extends to primary, secondary and tertiary healthcare facilities.
The document states that adverse events may first be identified at primary healthcare facilities and that equipping frontline personnel with mechanisms to recognise, document and report them can enable early detection.
For critical and life-saving devices used in high-risk settings such as intensive care, cardiology, neurosurgery, oncology and emergency care, the framework calls for active surveillance. Hospitals shall monitor identified critical devices on a weekly or monthly basis depending on their usage and risk profile.
The monitored list is to be prominently displayed in clinical departments such as intensive care units, operation theatres, catheterisation laboratories and specialty wards. A designated nodal person in each department will oversee monitoring, sensitise staff about potential risks and ensure timely reporting.
“Any adverse event, incident, near-miss, or malfunction related to the monitored devices shall be promptly reported to NCC-MvPI, IPC, in accordance with the prescribed timelines,” the document says.
It also places emphasis on devices covered by safety alerts issued by the IPC, asking hospitals to include them in their active surveillance lists and maintain heightened vigilance and documentation.
The MvPI, launched in 2015, has established a nationwide network of 775 Medical Device Adverse Event Monitoring Centres across India as of September 2026, according to the document.
The IPC functions as the National Coordination Centre (NCC) and uses reports to identify emerging safety signals and support evidence-based recommendations to regulatory authorities.
The guidance document provides for reporting through the IPC’s Adverse Drug Reactions Monitoring System (ADRMS), reporting forms and other modalities. Consumers can also directly report suspected adverse events, while an IPC toll-free helpline, 1800-180-3024, has been established to facilitate reporting.
The document says the ADRMS provides a centralised digital platform for reporting, monitoring, evaluation and analysis of adverse events involving medical products, including medical devices and in-vitro diagnostic devices. It supports real-time electronic reporting, tracking and follow-up of cases and signal detection.
The guidance document has been issued against the backdrop of increasing use of sophisticated medical devices, including connected devices, implantable devices, in-vitro diagnostics, artificial intelligence-enabled technologies and software as a medical device.
It notes that such developments bring “new and evolving categories of risk that require robust and continuous safety monitoring”.
