The use of AI and Machine Learning in Medical Devices is transforming healthcare by enabling faster diagnosis, personalized treatments, and predictive care. From AI-based imaging tools to machine learning algorithms in wearable devices, these technologies are creating new opportunities. However, since medical devices directly affect human lives, strong regulations are needed to ensure safety, accuracy, and ethical use. Governments and health authorities worldwide, including India, are now updating their rules to keep pace with this technological shift. What does AI And Machine Learning in Medical Devices Mean? AI and Machine Learning in Medical Devices refers to the use of intelligent algorithms and self-learning systems inside healthcare equipment and software. Why are AI And Machine Learning in Medical Devices Becoming Important in Healthcare? AI and Machine Learning in Medical Devices are important because they: This technology is creating a shift from reactive to predictive healthcare. What are the Global Regulations for AI And Machine Learning in Medical Devices? Globally, regulators are setting frameworks for AI and Machine Learning in Medical Devices: How are Indian Regulations Adapting for AI And Machine Learning in Medical Devices? India is slowly updating its rules for AI and Machine Learning in Medical Devices: What role does CDSCO play in Regulating AI And Machine Learning in Medical Devices? The CDSCO is responsible for: What Challenges do Regulators face in Adapting Rules for AI And Machine Learning in Medical Devices? Some major challenges are: How do Data Privacy and Cybersecurity Affect AI And Machine Learning in Medical Device Regulation? Data privacy and cybersecurity are key parts of regulation because AI-based devices depend on sensitive patient data. What Safety and Performance Standards are Required for AI And Machine Learning in Medical Devices? AI and Machine Learning in Medical Devices must follow: Clinical validation to ensure devices are safe for real patients. What Benefits will Clear Regulations bring for AI And Machine Learning in Medical Devices? Having clear rules for AI and Machine Learning in Medical Devices will: