@article{ART003189084},
author={Do Hyeun Kim},
title={Analysis and Investigation of International SaMD Policy Status},
journal={Journal of Software Assessment and Valuation},
issn={2092-8114},
year={2025},
volume={21},
number={1},
pages={41-50}
TY - JOUR
AU - Do Hyeun Kim
TI - Analysis and Investigation of International SaMD Policy Status
JO - Journal of Software Assessment and Valuation
PY - 2025
VL - 21
IS - 1
PB - Korea Software Assessment and Valuation Society
SP - 41
EP - 50
SN - 2092-8114
AB - With the advancement of digital technology, the importance and utilization of Software as a Medical Device (SaMD) have significantly increased, making regulatory and certification systems essential elements for driving innovation in the healthcare industry. This study compares and analyzes the policies and classification systems related to SaMD in the United States (FDA) and Europe (CE). The FDA adopts an approach based on past examples to classify SaMD into Class I, II, and III, while Europe employs a rule-based framework to classify SaMD and In Vitro Diagnostic Medical Devices (IVD) into more specific categories, applying the "waterfall" rule. Although the two regions differ in their regulatory approaches, they share a common goal of ensuring the safety and effectiveness of SaMD and facilitating its practical application in healthcare environments. Based on these findings, this study proposes policy insights to promote the digital health industry in Korea and emphasizes the importance of international collaboration and regulatory harmonization.
KW - SaMD;MDDS;MDR;Certification;Medical Device
DO -
UR -
ER -
Do Hyeun Kim. (2025). Analysis and Investigation of International SaMD Policy Status. Journal of Software Assessment and Valuation, 21(1), 41-50.
Do Hyeun Kim. 2025, "Analysis and Investigation of International SaMD Policy Status", Journal of Software Assessment and Valuation, vol.21, no.1 pp.41-50.
Do Hyeun Kim "Analysis and Investigation of International SaMD Policy Status" Journal of Software Assessment and Valuation 21.1 pp.41-50 (2025) : 41.
Do Hyeun Kim. Analysis and Investigation of International SaMD Policy Status. 2025; 21(1), 41-50.
Do Hyeun Kim. "Analysis and Investigation of International SaMD Policy Status" Journal of Software Assessment and Valuation 21, no.1 (2025) : 41-50.
Do Hyeun Kim. Analysis and Investigation of International SaMD Policy Status. Journal of Software Assessment and Valuation, 21(1), 41-50.
Do Hyeun Kim. Analysis and Investigation of International SaMD Policy Status. Journal of Software Assessment and Valuation. 2025; 21(1) 41-50.
Do Hyeun Kim. Analysis and Investigation of International SaMD Policy Status. 2025; 21(1), 41-50.
Do Hyeun Kim. "Analysis and Investigation of International SaMD Policy Status" Journal of Software Assessment and Valuation 21, no.1 (2025) : 41-50.
