2022年55個創新醫療器械產品獲批上市
發布時間:2023-02-15
2022年55個創新醫療器械產品獲批上市
比上一年增加57.1%
國家藥監局8日發布《2022年度醫療器械注冊工作報告》(以下簡稱“報告”)。報告顯示,2022年,高端醫療裝備國產化有新突破,國家藥監局共批準55個創新醫療器械產品上市,比2021年增加57.1%。
報告指出,2022年,國家藥監局按程序做好創新醫療器械、臨床急需醫療器械審評審批。獲批的55個創新醫療器械產品中,核心技術都有我國的發明專利權或者發明專利申請已經國務院專利行政部門公開,產品主要工作原理和作用機理為國內首創,具有顯著的臨床應用價值。
根據報告梳理,從2014年至2022年,國家藥監局共批準189個創新醫療器械。其中,境內創新醫療器械涉及15個省的134家企業,進口創新醫療器械涉及2個國家的8個企業。北京、上海、廣東、江蘇、浙江創新醫療器械獲批產品數量和相應企業數量最多,約占全部已批準的189個創新醫療器械的82.5%。
另據報告顯示,截至2022年年底,國家藥監局共批準新冠病毒檢測試劑136個,其中包括45個核酸檢測試劑、41個抗體檢測試劑、50個抗原檢測試劑,為疫情防控工作提供了有力保障。(記者 陳海波)


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