廣東省藥(yao)監局審(shen)評中(zhong)(zhong)心于2019年8月6日發布公(gong)告(gao)通知:生(sheng)物(wu)學(xue)試(shi)(shi)驗(yan)報(bao)告(gao)不(bu)強制在具(ju)有醫療(liao)器械(xie)檢(jian)(jian)(jian)驗(yan)資(zi)質(zhi)的檢(jian)(jian)(jian)測機(ji)構(gou)開展(zhan);第二類醫療(liao)器械(xie)注(zhu)冊(ce)審(shen)批提(ti)(ti)交(jiao)的檢(jian)(jian)(jian)驗(yan)報(bao)告(gao),不(bu)對(dui)檢(jian)(jian)(jian)驗(yan)報(bao)告(gao)中(zhong)(zhong)的檢(jian)(jian)(jian)驗(yan)類型進(jin)行審(shen)查(cha),即不(bu)一(yi)定(ding)要提(ti)(ti)交(jiao)注(zhu)冊(ce)檢(jian)(jian)(jian)驗(yan)報(bao)告(gao),但應提(ti)(ti)交(jiao)具(ju)有醫療(liao)器械(xie)檢(jian)(jian)(jian)驗(yan)資(zi)質(zhi)認(ren)定(ding)或中(zhong)(zhong)國計(ji)量(liang)認(ren)證(CMA)且在其(qi)承(cheng)檢(jian)(jian)(jian)范(fan)圍之內按照(zhao)相關標準進(jin)行試(shi)(shi)驗(yan),并開展(zhan)產品技術要求預評價工作(zuo)。
Q:1.生(sheng)物(wu)學實(shi)驗(yan)報告如何(he)提交,開展生(sheng)物(wu)學實(shi)驗(yan)的檢驗(yan)機(ji)構有(you)何(he)要求?
A:(1)醫療器械生物學評價中涉及生物學試驗的,其生物學試驗報告由申請人在申請注冊時作為研究資料提交。