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4月15日，國家藥監局(ju)器審中心發布10項(xiang)醫(yi)療器械注冊審查(cha)指導(dao)原則，涉(she)及骨科(ke)植(zhi)入(ru)物、口腔修復膜等。

　　《骨科植入物(wu)抗菌(jun)性能評(ping)價注冊審查(cha)指導原(yuan)則》適用于(yu)表面(mian)含(han)有(you)銀(yin)、碘或抗生(sheng)(sheng)(sheng)素(su)(su)涂(tu)層的(de)骨科植入物(wu)以(yi)及(ji)基體中(zhong)含(han)有(you)抗生(sheng)(sheng)(sheng)素(su)(su)成分的(de)骨科植入物(wu)（如(ru)(ru)抗生(sheng)(sheng)(sheng)素(su)(su)骨水泥等）抗菌(jun)性能評(ping)價的(de)相(xiang)關要求；對(dui)于(yu)含(han)有(you)其他(ta)抗菌(jun)成分的(de)骨科植入物(wu)可以(yi)參考本(ben)指導原(yuan)則中(zhong)相(xiang)應的(de)技術內容。本(ben)指導原(yuan)則不包含(han)對(dui)納(na)米(mi)抗菌(jun)涂(tu)層（例如(ru)(ru)納(na)米(mi)銀(yin)等）的(de)骨科植入物(wu)的(de)相(xiang)關要求。

　　《口(kou)腔(qiang)(qiang)修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)注冊審查指導(dao)(dao)原(yuan)(yuan)則(ze)》所涉及的(de)口(kou)腔(qiang)(qiang)修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)一(yi)般(ban)與(yu)口(kou)腔(qiang)(qiang)用骨(gu)(gu)(gu)填(tian)充材(cai)(cai)料聯(lian)合(he)使用，在口(kou)腔(qiang)(qiang)種植手術(shu)中用于(yu)重(zhong)建(jian)缺失牙(ya)患者口(kou)內種植區的(de)牙(ya)槽骨(gu)(gu)(gu)骨(gu)(gu)(gu)組(zu)(zu)織，引導(dao)(dao)骨(gu)(gu)(gu)組(zu)(zu)織/牙(ya)周組(zu)(zu)織再生。口(kou)腔(qiang)(qiang)修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)按(an)照(zhao)降解(jie)特性(xing)分為(wei)可吸(xi)收(shou)(shou)膜(mo)(mo)(mo)(mo)(mo)和(he)不(bu)可吸(xi)收(shou)(shou)膜(mo)(mo)(mo)(mo)(mo)，材(cai)(cai)質(zhi)涵蓋高(gao)分子材(cai)(cai)料、金屬材(cai)(cai)料。可吸(xi)收(shou)(shou)膜(mo)(mo)(mo)(mo)(mo)包括(kuo)(kuo)天然和(he)合(he)成聚(ju)(ju)(ju)合(he)物類(lei)(lei)修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)，天然修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)主(zhu)要(yao)(yao)為(wei)動物源(yuan)性(xing)膠原(yuan)(yuan)蛋白膜(mo)(mo)(mo)(mo)(mo)、絲(si)素蛋白膜(mo)(mo)(mo)(mo)(mo)等(deng)(deng)，合(he)成聚(ju)(ju)(ju)合(he)物類(lei)(lei)修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)包括(kuo)(kuo)聚(ju)(ju)(ju)乳(ru)酸膜(mo)(mo)(mo)(mo)(mo)等(deng)(deng)；不(bu)可吸(xi)收(shou)(shou)膜(mo)(mo)(mo)(mo)(mo)主(zhu)要(yao)(yao)包括(kuo)(kuo)聚(ju)(ju)(ju)四氟乙(yi)烯(xi)膜(mo)(mo)(mo)(mo)(mo)、鈦金屬膜(mo)(mo)(mo)(mo)(mo)等(deng)(deng)。本指導(dao)(dao)原(yuan)(yuan)則(ze)適(shi)用于(yu)天然可吸(xi)收(shou)(shou)修(xiu)復(fu)(fu)膜(mo)(mo)(mo)(mo)(mo)。不(bu)可吸(xi)收(shou)(shou)膜(mo)(mo)(mo)(mo)(mo)或其他可降解(jie)金屬合(he)金材(cai)(cai)質(zhi)的(de)可吸(xi)收(shou)(shou)膜(mo)(mo)(mo)(mo)(mo)等(deng)(deng)其他類(lei)(lei)型可參考適(shi)用部分。

　　此外，在(zai)骨(gu)(gu)(gu)科(ke)方面，《I型膠(jiao)原(yuan)(yuan)軟(ruan)骨(gu)(gu)(gu)修復(fu)產品注冊審(shen)(shen)查(cha)指導原(yuan)(yuan)則》適(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)所用(yong)(yong)(yong)(yong)(yong)(yong)(yong)原(yuan)(yuan)材(cai)料(liao)(liao)是由(you)動物組織(zhi)提取、分(fen)離及(ji)純化（交聯或(huo)非交聯）得到(dao)的(de)(de)I型膠(jiao)原(yuan)(yuan)蛋白而制成(cheng)(cheng)(cheng)的(de)(de)凝膠(jiao)狀支架產品；《可(ke)吸收骨(gu)(gu)(gu)內(nei)(nei)固(gu)(gu)(gu)定(ding)植(zhi)(zhi)入物注冊審(shen)(shen)查(cha)指導原(yuan)(yuan)則》適(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)由(you)合(he)成(cheng)(cheng)(cheng)高分(fen)子材(cai)料(liao)(liao)制成(cheng)(cheng)(cheng)或(huo)由(you)合(he)成(cheng)(cheng)(cheng)高分(fen)子材(cai)料(liao)(liao)混合(he)無機材(cai)料(liao)(liao)制成(cheng)(cheng)(cheng)，預(yu)期(qi)發(fa)揮骨(gu)(gu)(gu)與(yu)骨(gu)(gu)(gu)或(huo)骨(gu)(gu)(gu)與(yu)軟(ruan)組織(zhi)固(gu)(gu)(gu)定(ding)作(zuo)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)的(de)(de)第(di)三(san)類植(zhi)(zhi)入醫療(liao)器械；《金屬骨(gu)(gu)(gu)針(zhen)注冊審(shen)(shen)查(cha)指導原(yuan)(yuan)則》適(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)四肢(zhi)骨(gu)(gu)(gu)折(zhe)(zhe)復(fu)位(wei)時(shi)部分(fen)植(zhi)(zhi)入人體做牽引、配合(he)外固(gu)(gu)(gu)定(ding)支架進行(xing)四肢(zhi)骨(gu)(gu)(gu)折(zhe)(zhe)固(gu)(gu)(gu)定(ding)或(huo)單獨植(zhi)(zhi)入用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)四肢(zhi)骨(gu)(gu)(gu)折(zhe)(zhe)內(nei)(nei)固(gu)(gu)(gu)定(ding)的(de)(de)金屬骨(gu)(gu)(gu)針(zhen)產品；《記憶(yi)合(he)金肋(lei)骨(gu)(gu)(gu)板注冊審(shen)(shen)查(cha)指導原(yuan)(yuan)則》適(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)肋(lei)骨(gu)(gu)(gu)骨(gu)(gu)(gu)折(zhe)(zhe)內(nei)(nei)固(gu)(gu)(gu)定(ding)的(de)(de)記憶(yi)合(he)金肋(lei)骨(gu)(gu)(gu)接骨(gu)(gu)(gu)板；《胸骨(gu)(gu)(gu)捆扎固(gu)(gu)(gu)定(ding)系統(tong)注冊審(shen)(shen)查(cha)指導原(yuan)(yuan)則》適(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)開胸術中胸骨(gu)(gu)(gu)固(gu)(gu)(gu)定(ding)的(de)(de)胸骨(gu)(gu)(gu)捆扎固(gu)(gu)(gu)定(ding)系統(tong)，如用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)胸骨(gu)(gu)(gu)固(gu)(gu)(gu)定(ding)的(de)(de)柔性金屬絲(si)（分(fen)類編碼為(wei)13-01-05）、胸骨(gu)(gu)(gu)結扎帶（分(fen)類編碼為(wei)13-11-03）等(deng)；《顱(lu)骨(gu)(gu)(gu)修補網板系統(tong)注冊審(shen)(shen)查(cha)指導原(yuan)(yuan)則》適(shi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)于(yu)(yu)以修補、覆蓋、填(tian)充或(huo)固(gu)(gu)(gu)定(ding)顱(lu)骨(gu)(gu)(gu)缺損或(huo)孔洞為(wei)預(yu)期(qi)用(yong)(yong)(yong)(yong)(yong)(yong)(yong)途的(de)(de)顱(lu)骨(gu)(gu)(gu)修補網板系統(tong)。

　　口(kou)腔方面，《牙科樹(shu)脂(zhi)(zhi)類充(chong)填材料產品注冊審(shen)查指(zhi)導原則（2025年修訂版）》適(shi)用于(yu)充(chong)填和修復牙體各種(zhong)缺損的牙科樹(shu)脂(zhi)(zhi)類充(chong)填材料；《種(zhong)植(zhi)(zhi)用口(kou)腔骨填充(chong)材料注冊審(shen)查指(zhi)導原則》適(shi)用于(yu)動物源性異種(zhong)骨植(zhi)(zhi)入(ru)材料，經脫脂(zhi)(zhi)、脫蛋白、煅燒等工藝制成(cheng)。 

本文(wen)由廣州佳譽(yu)醫療(liao)器械有限(xian)公司(si)/佛山浩(hao)揚醫療(liao)器械有限(xian)公司(si)聯合(he)編輯(ji)