The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, has mandated all medical device license holders and manufacturers to report adverse events related to life-saving medical equipment on the Materiovigilance Programme of India (MvPI) platform. This directive aims to ensure early identification and mitigation of risks to safeguard public health.
Medical devices encompass a range of equipment, including electronic devices, implants, consumables, surgical instruments, and in-vitro diagnostic reagents. The regulation of these devices falls under the Drugs and Cosmetics Act, 1940, and Medical Device Rule, 2017. Notably, India relies on imports for 80% of its medical devices, necessitating stringent oversight.
Raghuvanshi emphasized the need for robust systems to identify, document, and report adverse events timely. He highlighted the MvPI platform’s importance for coordinated analysis and risk identification related to medical devices.
As reported by Livemint, post-market surveillance (PMS) is critical for ensuring device safety and performance, enabling regulatory authorities to address risks effectively. The DCGI also urged license holders and manufacturers to undergo training to enhance their proficiency in reporting and understanding adverse events.
Jatin Mahajan, Secretary of the Association of Diagnostic Manufacturers of India, noted that high-risk medical devices are more prone to adverse events, requiring thorough investigation and corrective actions in line with guidelines.