ABSTRACT:
The regulatory framework for emergency approval of medical devices in India is crucial for ensuring rapid access to essential technologies during public health crises. Governed by the Medical Devices Rules, 2017, and the Drugs and Cosmetics Act, 1940, this framework has evolved significantly, particularly in response to the COVID-19 pandemic. The Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare (MoHFW) oversee this process, which employs a risk-based classification system to determine the level of scrutiny required for different devices. In emergencies, traditional regulatory pathways are streamlined to expedite approvals for critical devices like ventilators and diagnostic kits. The introduction of Emergency Use Authorization (EUA) also called as expedited or accelerated approval process under the Medical Devices (Amendment) Rules, 2020, allows for faster access while maintaining safety standards. Key criteria for EUA include addressing urgent public health needs, lack of alternatives, and reasonable assurance of safety and effectiveness based on available data. The EUA process involves pre-submission consultations, a detailed application review, and ongoing post-market surveillance to ensure continued safety. Adjustments made during emergencies include accepting preliminary data and real-world evidence, allowing for rapid deployment without compromising patient safety. This regulatory flexibility is essential in managing healthcare emergencies effectively. International collaboration with bodies like the World Health Organization (WHO), United State Food Drug Administration, and European Medical Agency (EMA) further strengthens India’s regulatory framework, enabling faster availability of life-saving devices while maintaining global safety standards. The emergency approval process is an essential element in responding to public health emergencies, ensuring that critical medical devices reach patients in a timely and efficient manner.