Main Article Content
In the 21st century, the unhealthy lifestyle choices of people make them vulnerable to diseases, necessitating innovation in the pharmaceutical and medical device industries. As the demand for modern treatment grows, physicians are turning to Medical devices (MD). MD can be used to diagnose, monitor, prevent, treat, and alleviate diseases. Every year, the medical device industry experiences innovation and progress, establishing a robust regulatory framework by regulatory bodies that is often updated. The devices are integrated with software as an interface or functional component, leading to the better utility of the device. The software has progressed to the point where it can be utilized as a standalone medical device or as software in standard medical equipment. According to the FDA, when a software program is used to evaluate medical device data, it is generally classified as an accessory to a medical device or software. The International Medical Device Regulators Forum (IMDRF) produced a unified worldwide terminology for such software applications in 2014, i.e., "Software as a Medical Device" (SaMD), as well as a definition for the term. The article examines the use of software as a medical device, its current regulations in various countries, the challenges in those regulations, and their future scope.