Hospitals Asked to Strengthen Reporting of Medical Device-Related Adverse Events

Hospitals across India have been asked to establish stronger systems for identifying, documenting and reporting adverse events associated with medical devices. The updated guidance is part of the Materiovigilance Programme of India (MvPI) and has been developed by the Indian Pharmacopoeia Commission (IPC) in collaboration with WHO India and other stakeholders.

Under the revised framework, hospitals are expected to report suspected medical-device adverse events even when it has not yet been established that the device directly caused the incident. Serious events involving death or serious deterioration in health are to be reported to MvPI within 15 days. Non-serious incidents that could potentially result in serious harm have a reporting period of 30 days, while suspected unexpected serious adverse events are also subject to a 15-day reporting requirement for the concerned licensing authority.

The guidance covers a broad range of problems, including device malfunctions, deterioration in performance, incorrect or out-of-specification test results, design deficiencies, inaccurate labelling and use-related errors. Hospitals have also been advised to maintain detailed records of incidents, preventive maintenance, calibration and root-cause investigations.

For devices considered critical or life-saving, particularly those used in intensive care, cardiology, neurosurgery, oncology and emergency medicine, the guidance calls for active surveillance. Monitoring frequency is to be determined according to the device’s use and risk profile.

Healthcare facilities have also been asked to designate responsible personnel for monitoring and reporting and to train clinical, nursing and biomedical staff to recognise potential device-related problems.

The updated framework reflects the increasing use of sophisticated technologies, including connected devices, implantable products, in-vitro diagnostics and software-based medical devices.

22-09-2026