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更新|中國醫療器械注冊收費標準（2024年5月）
更新|中國醫療器械注冊收費標準（2024年5月）
更新|中國醫療器械注冊收費標準（2024年5月）
【CMDE】關于公開征求《預充式導管沖洗器注冊審查指導原則（征求意見稿）》意見的通知
CMDE結合醫療器械注冊法規、境內外注冊申報產品的特點及申報現狀，在總結技術審評實際情況，參考相關文獻資料的基礎上，制定了《預充式導管沖洗器注冊審查指導原則（公開征求意見稿）》。
【CMDE】關于公開征求《預充式導管沖洗器注冊審查指導原則（征求意見稿）》意見的通知
【收藏】醫療軟件全生命周期文件和記錄要求及注意事項
醫療軟件全生命周期文件和記錄要求及注意事項
【收藏】醫療軟件全生命周期文件和記錄要求及注意事項
【NMPA】《關于規范醫療器械產品分類界定工作的公告》解讀
《關于規范醫療器械產品分類界定工作的公告》解讀
【NMPA】《關于規范醫療器械產品分類界定工作的公告》解讀
【NMPA】國家藥監局關于實施《體外診斷試劑分類目錄》有關事項的通告（2024年第17號）
國家藥監局關于實施《體外診斷試劑分類目錄》有關事項的通告（2024年第17號）
【NMPA】國家藥監局關于實施《體外診斷試劑分類目錄》有關事項的通告（2024年第17號）
【收藏】體外診斷試劑適用儀器變更要做臨床試驗嗎？
體外診斷試劑適用儀器變更要做臨床試驗嗎
【收藏】體外診斷試劑適用儀器變更要做臨床試驗嗎？
醫療器械廣告這些問題，您了解嗎？（上）
醫療器械廣告的發布及管理，在法律法規中是有嚴格規定的，但是實踐中因為廣告內容不合規被處罰的案例數不勝數。醫療器械廣告應該注意以下幾方面內容
醫療器械廣告這些問題，您了解嗎？（上）
【收藏】臨床評價中等同器械的選擇
臨床評價中等同器械的選擇
【收藏】臨床評價中等同器械的選擇
北京市人工智能醫療器械生產質量管理規范檢查指南 （2024版）
北京市人工智能醫療器械生產質量管理規范檢查指南 （2024版）
北京市人工智能醫療器械生產質量管理規范檢查指南 （2024版）
【CMDE】關于2024年5月～6月醫療器械注冊受理前技術問題咨詢工作安排的通告（2024年第18號）
關于2024年5月～6月醫療器械注冊受理前技術問題咨詢工作安排的通告（2024年第18號）
【CMDE】關于2024年5月～6月醫療器械注冊受理前技術問題咨詢工作安排的通告（2024年第18號）
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