软件即医疗设备（SaMD）

The concept of Software as a Medical Device (SaMD) emerged to address the growing role of software in healthcare that operates independently from traditional medical hardware. The IMDRF’s foundational document, ‘Software as a Medical Device (SaMD): Key Definitions,’ clarified that SaMD is a medical device itself and must be regulated as such. This distinguishes it from software that is integral to a physical device (known as ‘software in a medical device’) or software that simply manages general health and wellness.

The regulatory framework for SaMD is risk-based, similar to hardware devices, but adapted for the unique nature of software. The risk categorization considers two main factors: the significance of the information provided by the SaMD for healthcare decisions (e.g., to treat, diagnose, drive clinical management) and the state of the healthcare situation or condition (e.g., critical, serious, non-serious). This creates a matrix to determine the device’s overall risk level, which in turn dictates the required level of regulatory scrutiny, including the need for clinical evidence and robust quality management systems. This framework allows regulators to oversee everything from low-risk diagnostic aids to high-risk software that directly informs life-or-death treatment decisions, ensuring patient safety in the rapidly evolving digital health landscape.