Global Regulatory Requirements for Software as a Medical Device (SaMD): A Comparative Review of International Regulatory Frameworks

Abstract

Software as a Medical Device (SaMD) has transformed healthcare by enabling diagnosis, treatment
planning, disease monitoring, and clinical decision support through standalone software applications. The
rapid growth of artificial intelligence (AI), machine learning (ML), mobile health applications, and digital
therapeutics has created significant regulatory challenges worldwide. Regulatory agencies such as the
United States Food and Drug Administration (FDA), European Medicines Agency (EMA) under the
Medical Device Regulation (MDR), Medicines and Healthcare products Regulatory Agency (MHRA),
Therapeutic Goods Administration (TGA), and the Central Drugs Standard Control Organization (CDSCO)
have developed frameworks to ensure the safety, effectiveness, cybersecurity, and clinical performance of
SaMD products. This review summarizes global regulatory requirements, compares major international
frameworks, and discusses emerging trends in AI-enabled SaMD regulation. The review highlights the
importance of harmonization efforts led by the International Medical Device Regulators Forum (IMDRF).
SaMD is generally defined as software intended for one or more medical purposes that performs these
purposes without being part of a hardware medical device.