@Article{info:doi/10.2196/46871,
author="Han, Yu
and Ceross, Aaron
and Bergmann, Jeroen",
title="Regulatory Frameworks for AI-Enabled Medical Device Software in China: Comparative Analysis and Review of Implications for Global Manufacturer",
journal="JMIR AI",
year="2024",
month="Jul",
day="29",
volume="3",
pages="e46871",
keywords="NMPA; medical device software; device registration; registration pathway; artificial intelligence; machine learning; medical device; device development; China; regulations; medical software",
issn="2817-1705",
doi="10.2196/46871",
url="https://ai.jmir.org/2024/1/e46871",
url="https://doi.org/10.2196/46871",
url="http://www.ncbi.nlm.nih.gov/pubmed/39073860"
}