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@article{181874,
        author = {Asma shaik and syam kumar kanigiri and Beena Devi Maddi and Venkata Nagabhushanam Maddi},
        title = {Regulatory framework for digital therapeutics [DTx] and software as a medicaldevice [SaMD] : a global perspective},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {12},
        number = {2},
        pages = {348-354},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=181874},
        abstract = {The rise of digital health solutions has paved the way for Digital Therapeutics (DTx) and Software as a Medical Device (SaMD) to become essential parts of today’s healthcare landscape. These innovative technologies deliver evidence-based therapeutic interventions, enhance patient outcomes, and provide fresh approaches to managing chronic illnesses. Yet, navigating the regulatory environment for DTx and SaMD can be quite tricky, as various regions have adopted different frameworks. This paper takes a closer look at the regulatory structures surrounding DTx and SaMD in major markets like the USFDA, EMA, PMDA, and CDSCO. We’ll discuss key regulatory requirements, classification criteria, clinical evaluation methods, and strategies for post-market surveillance. The paper emphasizes the need for harmonization, improved cybersecurity measures, and more streamlined approval processes to ensure global compliance and safeguard patient safety. Additionally, this review examines regulatory guidelines and showcases six case studies of DTx/SaMD products that have successfully gained approval, aiming to extract best practices for both developers and regulators.},
        keywords = {Digital Therapeutics (DTx), EMA, Regulatory Framework, Software as a Medical Device (SaMD), USFDA},
        month = {July},
        }