How Saudi Arabia Regulates Software as a Medical Device (SaMD)?
In recent years, Saudi Arabia has recognized the pivotal role of digital health solutions in modern healthcare. Central to this digital transformation is the regulation of Software as a Medical Device (SaMD). The Saudi Food and Drug Authority (SFDA) has established comprehensive guidelines, such as MDS-G23 Guidance on Software as a Medical Device, to ensure that SaMD products meet stringent safety and efficacy standards before entering the Saudi market. Understanding SaMD Softw...
