醫(yī)療器械臨床試驗(yàn)質(zhì)量管理相關(guān)問題解讀

　　一、關(guān)于臨床試驗(yàn)用醫(yī)療器械注冊檢驗(yàn)報告一年有效期問題

　　《醫(yī)療器械臨床試驗(yàn)質(zhì)量管理規(guī)范》第七條規(guī)定：“質(zhì)量檢驗(yàn)結(jié)果包括自檢報告和具有資質(zhì)的檢驗(yàn)機(jī)構(gòu)出具的一年內(nèi)的產(chǎn)品注冊檢驗(yàn)合格報告”。對于其中檢驗(yàn)機(jī)構(gòu)的一年內(nèi)的產(chǎn)品注冊檢驗(yàn)合格報告，在多中心開展臨床試驗(yàn)的情形，是以檢驗(yàn)報告出具時間至臨床試驗(yàn)牽頭單位倫理審查通過時間計算一年有效期；在非多中心開展臨床試驗(yàn)的情形，是以檢驗(yàn)報告出具時間至每家臨床試驗(yàn)機(jī)構(gòu)倫理審查通過時間分別計算一年有效期。

　　二、關(guān)于醫(yī)療器械臨床試驗(yàn)備案問題

　　依據(jù)《關(guān)于醫(yī)療器械臨床試驗(yàn)備案有關(guān)事宜的公告》（2015年第87號）第一條要求，開展醫(yī)療器械臨床試驗(yàn)，申辦者與每家臨床試驗(yàn)機(jī)構(gòu)簽訂協(xié)議或合同后，均可向申辦者/代理人所在地省級食品藥品監(jiān)督管理部門備案。備案后，即可開展臨床試驗(yàn)。同一個臨床試驗(yàn)項目多次備案時，申辦者應(yīng)當(dāng)同時提供前期已取得的所有備案表。省級食品藥品監(jiān)督管理部門在《醫(yī)療器械臨床試驗(yàn)備案表》“備案號”欄應(yīng)予以注明，做到同一項目臨床試驗(yàn)備案號統(tǒng)一可查。

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