广(guang)东(dong)省医(yi)疗(liao)器(qi)械技(ji)术审评中心于2019年8月6日发布(bu)公告(gao)通(tong)知：生(sheng)物学(xue)试验(yan)(yan)(yan)报告(gao)不强制在具(ju)有(you)医(yi)疗(liao)器(qi)械检(jian)(jian)验(yan)(yan)(yan)资质的(de)(de)检(jian)(jian)测机构开展(zhan)；第二类(lei)医(yi)疗(liao)器(qi)械注(zhu)册(ce)审批(pi)提交(jiao)的(de)(de)检(jian)(jian)验(yan)(yan)(yan)报告(gao)，不对(dui)检(jian)(jian)验(yan)(yan)(yan)报告(gao)中的(de)(de)检(jian)(jian)验(yan)(yan)(yan)类(lei)型进行(xing)审查，即不一定要(yao)提交(jiao)注(zhu)册(ce)检(jian)(jian)验(yan)(yan)(yan)报告(gao)，但应提交(jiao)具(ju)有(you)医(yi)疗(liao)器(qi)械检(jian)(jian)验(yan)(yan)(yan)资质认(ren)定和中国计量认(ren)证(zheng)（CMA）且在其承检(jian)(jian)范围之内按照相关标(biao)准进行(xing)试验(yan)(yan)(yan)，并开展(zhan)产品技(ji)术要(yao)求(qiu)预评价工作。
1.生(sheng)物学实验报告(gao)如何提交，开展生(sheng)物学实验的检验机构有何要求？
（1）医疗器械生(sheng)物学评(ping)价中涉及生(sheng)物学试验的，其生(sheng)物学试验报告由申(shen)请(qing)人(ren)在申(shen)请(qing)注册(ce)时作为研究资料提交(jiao)。
（2）开(kai)展(zhan)生(sheng)物(wu)学试验(yan)(yan)，应(ying)委(wei)托具(ju)有医疗(liao)器械检(jian)验(yan)(yan)资(zi)质认定且在其(qi)承(cheng)检(jian)范围之内的(de)(de)生(sheng)物(wu)学实(shi)验(yan)(yan)室(shi)(shi)按照相(xiang)关标准进行(xing)试验(yan)(yan)。国外(wai)实(shi)验(yan)(yan)室(shi)(shi)出具(ju)的(de)(de)生(sheng)物(wu)学试验(yan)(yan)报(bao)告，应(ying)附(fu)有国外(wai)实(shi)验(yan)(yan)室(shi)(shi)表(biao)明(ming)其(qi)符(fu)合GLP实(shi)验(yan)(yan)室(shi)(shi)要求(qiu)的(de)(de)质量保证文件。因《医疗(liao)器械检(jian)测机构资(zi)格认可办法（试行(xing)）》（国药监(jian)械〔2003〕125号）已作废，因此(ci)不强(qiang)制要求(qiu)生(sheng)物(wu)学实(shi)验(yan)(yan)在具(ju)有医疗(liao)器械检(jian)验(yan)(yan)资(zi)质的(de)(de)检(jian)测机构开(kai)展(zhan)。
2.企业在(zai)申请注册申报(bao)或(huo)补充检(jian)(jian)验时是否一定要提交(jiao)注册检(jian)(jian)验报(bao)告吗？
按(an)照(zhao)省局相关(guan)要(yao)求(qiu)，医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)注(zhu)册申(shen)请资(zi)料中的(de)(de)(de)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)报(bao)(bao)告(gao)，应执行(xing)(xing)《医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)监(jian)(jian)督管(guan)(guan)理(li)条例》和原(yuan)国(guo)家(jia)食品(pin)(pin)(pin)(pin)药(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)督管(guan)(guan)理(li)总(zong)(zong)局办公(gong)厅2017年12月29日(ri)印发《关(guan)于做好医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)有关(guan)工作的(de)(de)(de)通知》（食药(yao)监(jian)(jian)办械(xie)管(guan)(guan)[2017]187号(hao)）的(de)(de)(de)要(yao)求(qiu)。参照(zhao)原(yuan)食品(pin)(pin)(pin)(pin)药(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)督管(guan)(guan)理(li)总(zong)(zong)局医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)技术审(shen)评(ping)中心关(guan)于认(ren)(ren)可医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)委托检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)报(bao)(bao)告(gao)的(de)(de)(de)的(de)(de)(de)做法(fa)，后续(xu)省局各(ge)相关(guan)部门(men)办理(li)第二(er)类医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)注(zhu)册审(shen)批事项(xiang)时，不(bu)(bu)对检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)报(bao)(bao)告(gao)中的(de)(de)(de)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)类型进(jin)(jin)行(xing)(xing)审(shen)查，故(gu)企(qi)业申(shen)请注(zhu)册申(shen)报(bao)(bao)或补充(chong)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)时不(bu)(bu)一(yi)定(ding)要(yao)提(ti)交注(zhu)册检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)报(bao)(bao)告(gao)，但应提(ti)交具有医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)资(zi)质认(ren)(ren)定(ding)和中国(guo)计量认(ren)(ren)证(zheng)（CMA）且在其(qi)承检(jian)(jian)(jian)(jian)(jian)范围之内(nei)按(an)照(zhao)相关(guan)标准进(jin)(jin)行(xing)(xing)试验(yan)(yan)(yan)(yan)。各(ge)医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)机构要(yao)严格按(an)照(zhao)《食品(pin)(pin)(pin)(pin)药(yao)品(pin)(pin)(pin)(pin)监(jian)(jian)管(guan)(guan)总(zong)(zong)局关(guan)于印发医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)机构开展(zhan)(zhan)医(yi)疗(liao)(liao)(liao)(liao)器(qi)(qi)械(xie)产品(pin)(pin)(pin)(pin)技术要(yao)求(qiu)预(yu)评(ping)价工作规定(ding)的(de)(de)(de)通知》（食药(yao)监(jian)(jian)械(xie)管(guan)(guan)〔2014〕192号(hao)）的(de)(de)(de)要(yao)求(qiu)开展(zhan)(zhan)产品(pin)(pin)(pin)(pin)技术要(yao)求(qiu)预(yu)评(ping)价工作，充(chong)分考虑国(guo)家(jia)标准、行(xing)(xing)业标准的(de)(de)(de)完整(zheng)性(xing)和适宜(yi)性(xing)，确保检(jian)(jian)(jian)(jian)(jian)验(yan)(yan)(yan)(yan)报(bao)(bao)告(gao)符合产品(pin)(pin)(pin)(pin)注(zhu)册的(de)(de)(de)相关(guan)要(yao)求(qiu)。
