PDF(858 KB)
美国FDA医疗器械监管数字化转型的进展分析及eSTAR模板的应用
沈海南, 侯艳, 丁金聚, 张译丹, 刘斌
中国药事 ›› 2024, Vol. 38 ›› Issue (5) : 603-610.
PDF(858 KB)
PDF(858 KB)
美国FDA医疗器械监管数字化转型的进展分析及eSTAR模板的应用
({{custom_author.role_cn}}), {{javascript:window.custom_author_cn_index++;}}Analysis of the Progress in Digital Transformation of Medical Device Regulation by the FDA and the Application of the Medical Device Electronic Submission Template and Resource (eSTAR)
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