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擴大醫療器械註冊人制度試點,國內醫療器械龍頭將受惠

國家藥品監督管理局發布《關於擴大醫療器械註冊人制度試點工作的通知》,進一步擴大醫療器械註冊人制度試點。北京、天津、河北、遼寧、黑龍江、上海、江蘇、浙江、安徽、福建、山東、河南、湖北、湖南、廣東、廣西、海南、重慶、四川、雲南、陝西等21個省、自治區、直轄市將參與是次醫療器械註冊人制度試點。《通知》參與試點工作的註冊人和受託生產企業應當簽訂委託合同和質量協議,並對產品註冊、變更和生產企業許可證辦理程序進行了規定,同時強調各級藥品監管部門應當加強對註冊人履行保證醫療器械質量、上市銷售與服務、醫療器械不良事件監測與評價、醫療器械召回等義務情況的監督管理。

是次政策對醫療器械行業提出更嚴格監管,這或使公司成本提升,質素不良的小型公司被迫退出市場或被收購,這有助提高行業整合度。此外,這同樣有助提升醫療器械行業門檻,令小型公司難以進入市場。我們重點推介春立醫療(1858.hk)和愛康醫療(1789.hk),他們均為國內領先醫療器械公司,相信會受惠於是次政策。

撰稿: 李學滔研究分析員
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