The regulatory landscape for SaMD varies from country to country, with each region implementing stringent measures to ensure the safety and effectiveness of these digital solutions. Regulatory bodies like the IMDRF, US FDA, Saudi FDA, Thai FDA, and TGA Australia play pivotal roles in safeguarding patient safety and maintaining the efficacy of SaMD products. In the United States, the FDA classifies SaMD based on risk and enforces strict pre-market submission and quality control standards. In Europe, CE marking requirements under MDR ensure conformity with essential standards, while countries like Brazil, Saudi Arabia, India, Thailand, Australia, and Japan have their own unique regulatory processes tailored to their healthcare landscapes.