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Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight.

PMID: 41533265 · 2026-01-14

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학술지Journal of medical systems

연도2026-01-14

PMID41533265

초록

Software as a Medical Device (SaMD) has become indispensable in diagnostics, treatment planning, and patient monitoring. While high-income countries have introduced clear regulatory frameworks, Bangladesh and many low- and middle-income countries (LMICs) still lack tailored pathways for medical software approval (IMDRF. Software as a Medical Device (SaMD): Key Definitions (IMDRF/SaMD WG/N10FINAL:(2013)); IMDRF. Software as a Medical Device (SaMD): Clinical Evaluation (IMDRF/SaMD WG/N41FINAL:(201

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