India Expands Medical Device Safety Monitoring to Cover Software Failures and Cybersecurity Risks

India has revised its medical-device safety-monitoring framework to strengthen the reporting and investigation of incidents involving medical equipment. The updated guidelines bring software malfunctions, cybersecurity vulnerabilities and risks associated with artificial-intelligence-enabled devices within the scope of routine safety surveillance.

The guidelines were developed by the Indian Pharmacopoeia Commission (IPC) under the Materiovigilance Programme of India, taking into account safety recommendations from the World Health Organization. The revised framework introduces a 100-point scoring system to evaluate the quality of incident reporting across 775 monitoring centres in the country.

A significant change is the extension of surveillance beyond large hospitals to primary healthcare centres and village clinics. Frontline healthcare workers, including auxiliary nurse midwives, are expected to report equipment failures directly. Hospitals must report serious adverse events within 15 days, while non-serious incidents and near misses must be reported within 30 days.

The revised system also shifts incident reporting to the digital Adverse Drug Reactions Monitoring System portal, replacing paper-based submissions. Monitoring centres are required to conduct baseline studies within 30 days of relevant safety notices or recalls issued by overseas regulators. These studies will help establish whether affected devices remain in use in Indian healthcare facilities.

Hospitals are also expected to strengthen internal oversight by appointing designated officers and establishing expert committees to review incidents and investigate their root causes. Critical equipment used in intensive care units and operating theatres will receive particular attention.

Safety concerns identified by the IPC may be referred to the Central Drugs Standard Control Organization for further regulatory action, including safety alerts and nationwide recalls. Patients can also report device-related problems through digital platforms and a toll-free helpline.

The revised framework aims to improve early detection of device-related risks and strengthen accountability across India's healthcare system.

09-10-2026