頁籤選單縮合
題名 | 透過電腦輔助偵測軟體,比較探討醫療器材於美國與我國上市之法規=Through Computer-Aided Detection Software, Comparing by Discussing and Analyzing the Regulatory Requirements for Marketing Medical Devices in the United States and in Taiwan |
---|---|
作者 | 鄭匡善; |
期刊 | 科技法律透析 |
出版日期 | 20120900 |
卷期 | 24:9 2012.09[民101.09] |
頁次 | 頁20-43 |
分類號 | 410.025 |
語文 | chi |
關鍵詞 | 醫療器材; 上市前通知; 實質等同; 類似品; 行政程序法; 政府資訊公開法; Pre-market notification; Substantially equivalent; Predicate device; The Administrative Procedure Act; The Freedom of Government Information Law; |