SOFTWARE AS A MEDICAL DEVICE (SAMD) AND ANVISA’S REGULATORY FRAMEWORK: CHALLENGES AND OPPORTUNITIES
DOI:
https://doi.org/10.56238/revgeov16n5-070Keywords:
Software as a Medical Device, ANVISA, Health Regulation, Artificial Intelligence in Healthcare, Cybersecurity, Data ProtectionAbstract
The regulation of Software as a Medical Device (SaMD) by Brazil’s National Health Surveillance Agency (ANVISA) has become essential amid the rapid growth of digital health technologies, particularly those based on artificial intelligence (AI). This paper examines the conceptual foundations of SaMD, ANVISA’s risk classification system, and the regulatory process for registration, monitoring, and validation of medical software. Drawing on a comparative analysis of national and international guidelines—especially those issued by the International Medical Device Regulators Forum (IMDRF)—the study highlights requirements for cybersecurity, traceability, clinical validation, and post-market surveillance. Findings reveal challenges in aligning existing regulations with the fast pace of technological innovation, while also identifying opportunities to enhance digital health governance in Brazil. The article concludes that an adaptive and transparent regulatory framework, harmonized with global standards and compliant with Brazil’s General Data Protection Law (LGPD), is vital to ensure patient safety and promote sustainable innovation in the healthcare ecosystem.
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References
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