India overhauls medical device safety rules, expands digital surveillance

Summary

New guidelines widen monitoring of AI-enabled devices, software glitches and cybersecurity risks while extending reporting to primary health centres.

NEW DELHI: India has overhauled its medical device safety-monitoring framework, bringing software glitches, cybersecurity risks and artificial intelligence (AI)-enabled technologies into routine surveillance while expanding reporting beyond major hospitals to primary health centres and village clinics.

The revised guidelines, developed by the Indian Pharmacopoeia Commission (IPC) following safety recommendations from the World Health Organization (WHO), introduce a 100-point scoring metric to assess reporting quality across 775 monitoring centres nationwide, according to two government officials familiar with the development and a document reviewed by Mint.

The revised guidelines have been circulated to state governments for implementation.

The changes are significant for India's $30 billion medical device industry, widening surveillance of products and the settings in which they are used. Frontline workers, including auxiliary nurse midwives, have been directed to report equipment failures directly, while hospitals must report serious adverse events within 15 days and non-serious faults and near misses within 30 days.

Incident reporting has also shifted entirely to the digital Adverse Drug Reactions Monitoring System (ADRMS) portal, doing away with paper submissions. In addition, mandatory 30-day baseline studies have been introduced to check whether products recalled by foreign regulators are circulating in Indian healthcare facilities, according to the document.

The overhaul has been rolled out under Version 1.3 of the Guidance Document for Hospitals in India for Safety Monitoring and Reporting of Medical Devices Related Incidents/Adverse Events (2026), published under the Materiovigilance Programme of India (MvPI).

Wider surveillance

The document lays out an operational model across public and private hospitals, aligning institutional tracking with patient safety standards set by the National Accreditation Board for Hospitals & Healthcare Providers (NABH). Tertiary and secondary hospitals are required to appoint departmental nodal officers and set up a Materiovigilance Expert Committee (MEC) to conduct monthly case reviews and root-cause analyses.

At the primary healthcare level, frontline staff are being trained to identify and escalate equipment risks before patient harm occurs. The guidelines also require monitoring centres to initiate and complete baseline studies within 30 days whenever regulators such as the US Food and Drug Administration, European regulators or Australia's TGA issue recalls or field safety corrective notices.

The rules also mandate active surveillance of critical equipment in high-dependency wards, requiring intensive care units and operation theatres to prominently display lists of monitored devices.

Emerging safety signals flagged by IPC will be shared with the Central Drugs Standard Control Organization (CDSCO) for regulatory enforcement, including safety alerts or nationwide recalls. Patients can also flag faulty devices directly through an online form, a mobile application or a toll-free helpline operating across 10 Indian languages.

Highlighting the need to monitor digital risks, the one of the officials cited earlier said, "The expanding use of advanced technologies across clinical settings offers significant benefits for patient care, while also introducing new and evolving categories of risk that require robust and continuous safety monitoring."

He added that the guidance will "help ensure the safe and effective use of medical devices, including the emerging generation of AI-enabled and software-driven medical technologies, across India."

Queries emailed to the ministry of health spokesperson and CDSCO remained unanswered till press time.

Industry response

"AiMeD welcomes stronger materiovigilance, including digital reporting and extending it to primary health centres. Manufacturers must act on incident reports and recalls, so their practical input is essential, especially for MSMEs. Compliance should be proportionate to device risk, and medical devices must not be overshadowed by pharma in a drug-reporting system. This again shows the need for a dedicated Medical Devices Act and a single regulator, with industry consulted from the start," said Rajiv Nath, forum coordinator, Association of Indian Manufacturers of Medical Devices (AiMed).

Health experts said India's revised medical device safety framework is a much-needed intervention.

Dr Aashish Chaudhry, managing director at Delhi-based super-speciality hospital Aakash Healthcare, said, "As doctors, we have seen instances where certain implants or medical devices have not delivered adequately, while concerns have not always received timely attention. The new surveillance framework can strengthen reporting, accountability and corrective action. It is equally important for doctors and healthcare institutions to become more compliant and proactive in reporting adverse events and device failures. If an innovation does not benefit patients or compromises safety, it must be investigated, addressed and, where necessary, recalled promptly."

The revised framework therefore expands the surveillance net from hospitals and specialist monitoring centres to frontline healthcare workers and patients, while moving incident reporting onto a single digital platform and setting defined timelines for escalation and review.