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推進醫療器械審評制度改革 浙江成全國首個試點省

        11月13日下午,省食品藥品監督管理局(簡稱“省食藥監局”)與國家食品藥品監督管理總局(簡稱“國家總局”)簽訂了醫療器械審評制度改革合作協議。作為醫療器械產業強省的浙江,成為了全國首個開展推進“深化審評審批制度改革、鼓勵藥品醫療器械創新”的落地試點省。
  近年來,我省醫療器械產業發展迅速,以余杭生物醫藥高新技術產業園區為代表的醫療器械特色園區、產業帶如雨后春筍般建立建設起來,推動了“浙造器械”名企、強企的發展。截至目前,全省共有醫療器械生產企業1299家,上市公司7家,醫療器械產業年均增速保持在15%以上,一批企業、產品在國內處于領先水平。

  為了配合醫療器械產業發展的勢頭,我省高度重視醫療器械產業發展和安全監管,堅持“精準監管”與“精準服務”并重,為醫療器械企業發展提供了便利。以余杭生物醫藥高新技術產業園區為例,審評審批服務中心從省食藥監局“搬”進了園區,企業足不出戶就可以完成審批工作。
  此次合作協議的簽訂,是我省醫療器械審評制度改革的一次機遇。記者在簽約儀式上了解到,協議簽訂后,國家總局可以直接指導浙江省醫療器械的審評工作,為在全國推行審評報告公開和結果公開積累經驗。同時,國家總局和省食藥監局可以利用各自優勢,如國家總局的專業技術、人才隊伍的優勢,省食藥監局的監管體系健全等優勢,聯合起來,加強審評制度的創新研究,推進審評模式的改革。

  根據協議,我省將建立“醫療器械技術審評中心醫療器械創新浙江服務站”。未來,省食藥監局將細化實施方案,健全工作機制,進一步激發醫療器械產業創新發展活力。(來源:浙江在線)
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