陽普醫療(300030.SZ)子公司預充式導管沖洗器(生理鹽水)終止註冊
格隆匯8月15日丨陽普醫療(300030.SZ)公佈,近日,公司全資子公司陽普醫療(湖南)有限公司(“湖南陽普”)收到了由國家食品藥品監督管理總局批覆的《醫療器械/體外診斷試劑不予註冊批件》。
產品名稱:預充式導管沖洗器(生理鹽水);臨牀用途:用於不同藥物治療的間隙,封閉、沖洗導管的管路末端;不予註冊理由:器審中心於2018年7月13日向申請人發送了補充資料通知,目前申請人尚未按照通知要求將資料一次性補回。根據《醫療器械註冊證管理辦法》第三十五條,對該註冊申請項目不予註冊。
公司高度重視新產品研發及技術創新,並嚴格執行以顧客需求為導向的新產品開發理念。此次預充式導管沖洗器註冊過程中,行業政策和市場需求發生了變化,公司研究決定據此對產品設計進行調整和創新。因此,在資料補充階段,湖南陽普未主動提供補充資料,此次新產品註冊終止。未來,公司及子公司將繼續嚴格按照市場需求和技術規範進行更全面、系統、規範的開發設計,重新向國家食品藥品監督管理總局申請再註冊事宜。
此次產品註冊終止不會對公司當期及未來的生產經營與業績產生重大影響。公司將進一步加強現有新產品的推廣和銷售,提升公司業績。
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