Artificial intelligence (AI) has emerged as a transformative technology in the medical devices industry, promising revolutionary advancements in diagnostics, treatment planning, and patient care. However, the rapid proliferation of AI-driven medical devices has raised concerns regarding patient safety, data privacy, and regulatory oversight. This chapter provides a comprehensive review of the current regulatory frameworks governing AI applications in medical devices. By analyzing existing regulations and recent developments, this review aims to identify gaps, challenges, and opportunities in the regulation of AI in the medical devices industry and propose recommendations for harmonized approaches to ensure the safe and effective deployment of AI technologies in healthcare settings. Artificial intelligence will be utilized more frequently within the healthcare industry because of the increasing complexity and volume of data currently being collected. Payers, providers of care, and organizations in the life sciences industry are already making use of a variety of AI technologies. The most important categories of applications are those that include making suggestions for treatment and diagnosis, encouraging patient participation and adherence, and taking administrative actions. Although there are numerous occasions in which artificial intelligence is capable of doing healthcare duties as well as or even better than humans, implementation factors will prohibit the widespread automation of professions held by healthcare professionals for a considerable amount of time.