醫療器械臨床試驗質(zhì)量管理相關(guān)問(wèn)題解讀

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

　　《醫療器械臨床試驗質(zhì)量管理規范》第七條規定：“質(zhì)量檢驗結果包括自檢報告和具有資質(zhì)的檢驗機構出具的一年內的產(chǎn)品注冊檢驗合格報告”。對于其中檢驗機構的一年內的產(chǎn)品注冊檢驗合格報告，在多中心開(kāi)展臨床試驗的情形，是以檢驗報告出具時(shí)間至臨床試驗牽頭單位倫理審查通過(guò)時(shí)間計算一年有效期；在非多中心開(kāi)展臨床試驗的情形，是以檢驗報告出具時(shí)間至每家臨床試驗機構倫理審查通過(guò)時(shí)間分別計算一年有效期。

　　二、關(guān)于醫療器械臨床試驗備案問(wèn)題

　　依據《關(guān)于醫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(kāi)展醫療器械臨床試驗，申辦者與每家臨床試驗機構簽訂協(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督管理部門(mén)備案。備案后，即可開(kāi)展臨床試驗。同一個(gè)臨床試驗項目多次備案時(shí)，申辦者應當同時(shí)提供前期已取得的所有備案表。省級食品藥品監督管理部門(mén)在《醫療器械臨床試驗備案表》“備案號”欄應予以注明，做到同一項目臨床試驗備案號統一可查。

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