醫(yī)療器械臨床試驗質(zhì)量管理相關(guān)問題解讀

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

　　《醫(yī)療器械臨床試驗質(zhì)量管理規(guī)范》第七條規(guī)定：“質(zhì)量檢驗結(jié)果包括自檢報告和具有資質(zhì)的檢驗機(jī)構(gòu)出具的一年內(nèi)的產(chǎn)品注冊檢驗合格報告”。對于其中檢驗機(jī)構(gòu)的一年內(nèi)的產(chǎn)品注冊檢驗合格報告，在多中心開展臨床試驗的情形，是以檢驗報告出具時間至臨床試驗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的情形，是以檢驗報告出具時間至每家臨床試驗機(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)療器械臨床試驗備案問題

　　依據(jù)《關(guān)于醫(yī)療器械臨床試驗備案有關(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，申辦者與每家臨床試驗機(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。同一個臨床試驗項目多次備案時，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)療器械臨床試驗備案表》“備案號”欄應(yīng)予以注明，做到同一項目臨床試驗備案號統(tǒng)一可查。

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