The Health Ministry of India has announced plans to establish an expert committee focused on monitoring and analyzing adverse events related to medical devices, with the aim of enhancing patient safety. The panel will assess risks associated with devices like X-ray machines, implants, surgical instruments, and in-vitro diagnostic reagents, and recommend measures to address safety concerns.

Key Highlights:
Formation of Expert Panel:

• The committee will consist of specialists in cardiology, gastroenterology, gynaecology, neurology, and radiology.

• It will focus on monitoring, recording, and analyzing the root causes of adverse events associated with medical devices.

Materiovigilance Programme of India (MvPI) Role:

• India Pharmacopoeia Commission (IPC) oversees the materiovigilance programme.

• MvPI conducts initial examinations of adverse event reports and collaborates with organizations like the National Health Systems Resource Centre (NHSRC), Sree Chitra Tirunal Institute of Medical Sciences (SCTIMST), and the Central Drugs Standard Control Organization (CDSCO) to determine necessary actions.

• MvPI recommendations are sent to CDSCO for regulatory action and to Medical Device Adverse Event Monitoring Centres (MDMCs) across India.

Challenges in India’s Medical Device Sector:

• 80% of medical devices in India are imported, with over 60% being pre-owned medical electronics equipment.

• Experts highlight adverse events are more common in refurbished or pre-owned devices due to lack of calibration facilities and regulatory oversight.

Government Initiatives:

• The Indian government has recently halted the import of refurbished medical devices.

• However, experts stress the need for better regulatory frameworks to ensure patient safety, improve certification processes, and align with international safety standards.

Statements from Leaders or Officials:

• Rajiv Nath, Association of Indian Manufacturers of Medical Devices (AIMeD):

“Lack of calibration facilities and insufficient regulatory oversight can lead to adverse diagnostic consequences and patient exposure risks.”

• Dr. Sudhir Srivastava, Founder & CEO, SS Innovations:

“While halting the import of refurbished devices is a positive step, India’s regulatory focus on patient safety remains insufficient. There is a need for comprehensive adverse event reporting and alignment with international standards.”The formation of this expert committee is part of the government’s broader strategy to strengthen India’s medical device regulatory framework. As the domestic medtech market is projected to grow from $12 billion in 2023-24 to $50 billion by 2030, enhancing patient safety protocols and improving regulatory oversight will be crucial to support sustainable growth and ensure high-quality healthcare delivery.