Medical device regulation in India encounters several challenges navigating the regulatory landscape. These include complex registration processes, evolving quality standards, and the need for local clinical data. Compliance with diverse state regulations and varying interpretations of guidelines pose additional hurdles. Ensuring timely approvals amidst regulatory updates and the absence of a unified regulatory body can also take time and effort. Effective navigation requires strategic planning, strong regulatory expertise, and a proactive approach to stay abreast of evolving requirements.