196A COMPREHENSIVE STUDY ON THE COMPARISON OF REGULATION OF MEDICAL DEVICES IN THE EUROPEAN UNION, INDIA AND THE UNITED STATESThe healthcare industry is supported by three essential components: drugs, vaccines, and medical devices, each crucial for patient care and treatment. Medical devices encompass a broad spectrum from basic tools like bandages and syringes to advanced technologies integrating bioinformatics, nanotechnology, and artificial intelligence. Recognizing the need for standardized definitions and regulatory frameworks across nations, the World Health Organization (WHO) introduced guidelines in 2003 to define medical devices uniformly. Additionally, the Global Harmonization Task Force (GHTF) was established, comprising international regulatory bodies and stakeholders, aimed at fostering global alignment in medical device regulations despite varying national standards. This study examines and compares the medical device regulations of India, the USA, and the European Union (EU), highlighting key differences and regulatory approachesdinakarreddya.sun@gmail.comResearch1412024 Medical devices, Regulation, Global harmonization, Healthcare industry, Patient safetyVenodoti Bhargavi1, Avinash Kumar G2*, Manasa E2, Thirupalu GDepartment of Pharmaceutics, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore-524346, Andhra Pradesh, India