• 分(fen)類：政策法規
• 作者：
• 來(lai)源：
• 發(fa)布時(shi)間：2019-02-13
• 訪(fang)問量：78

【概要描述】一、關于臨(lin)(lin)床試驗(yan)(yan)(yan)用(yong)醫(yi)療(liao)器械注冊(ce)檢(jian)(jian)驗(yan)(yan)(yan)報(bao)告(gao)(gao)一年有效(xiao)期(qi)問題　　《醫(yi)療(liao)器械臨(lin)(lin)床試驗(yan)(yan)(yan)質量管理(li)規范》第七條(tiao)規定：“質量檢(jian)(jian)驗(yan)(yan)(yan)結果(guo)包括自(zi)檢(jian)(jian)報(bao)告(gao)(gao)和具有資質的(de)檢(jian)(jian)驗(yan)(yan)(yan)機構出具的(de)一年內(nei)(nei)的(de)產(chan)品注冊(ce)檢(jian)(jian)驗(yan)(yan)(yan)合格報(bao)告(gao)(gao)”。對于其中(zhong)檢(jian)(jian)驗(yan)(yan)(yan)機構的(de)一年內(nei)(nei)的(de)產(chan)品注冊(ce)檢(jian)(jian)驗(yan)(yan)(yan)合格報(bao)告(gao)(gao)，在多中(zhong)心開展臨(lin)(lin)床試驗(yan)(yan)(yan)的(de)情形，是以檢(jian)(jian)驗(yan)(yan)(yan)報(bao)告(gao)(gao)出具時間至(zhi)臨(lin)(lin)床試驗(yan)(yan)(yan)牽頭單位倫(lun)理(li)審查(cha)通過時間計算一年有效(xiao)期(qi)；在非多中(zhong)心開展臨(lin)(lin)床試驗(yan)(yan)(yan)的(de)情形，是以檢(jian)(jian)驗(yan)(yan)(yan)報(bao)告(gao)(gao)出具時間至(zhi)每家(jia)臨(lin)(lin)床試驗(yan)(yan)(yan)機構倫(lun)