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【問(wen)(wen)】我司有關于第二類(lei)醫療器械獨立軟件的相關問(wen)(wen)題欲咨詢貴單位，具體問(wen)(wen)題如(ru)下：

1，第二類醫療器械(xie)獨立軟件(jian)是否應明確所(suo)有可聯合(he)使用的(de)產(chan)品？

2，注冊過程中(zhong)是否應提交與所有可聯合使用的產品在聯合使用過程中(zhong)的相關(guan)臨床資(zi)料？

【答】關于(yu)(yu)(yu)您咨詢(xun)(xun)的(de)問題，經(jing)核實回復(fu)如下：因獨(du)(du)立(li)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)產(chan)(chan)品(pin)涉及(ji)的(de)內容(rong)比較復(fu)雜，不便(bian)于(yu)(yu)(yu)簡單給出“是”或(huo)“否”的(de)答復(fu)。針對咨詢(xun)(xun)問題作規則性(xing)答復(fu)如下：1、獨(du)(du)立(li)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)的(de)產(chan)(chan)品(pin)技(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)和使用(yong)(yong)說明書需參照《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)注冊(ce)審(shen)查(cha)指(zhi)導(dao)(dao)原(yuan)(yuan)則（2022年修訂版(ban)）》的(de)附(fu)(fu)件(jian)(jian)(jian)：“獨(du)(du)立(li)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)產(chan)(chan)品(pin)技(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)模板”，給出相關內容(rong)，如：2.1.4 接(jie)口(kou)(kou)(kou)（指(zhi)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)本身(shen)提(ti)(ti)供的(de)接(jie)口(kou)(kou)(kou)）；2.1.5 必(bi)備(bei)軟(ruan)(ruan)(ruan)(ruan)硬(ying)件(jian)(jian)(jian)（正常運(yun)行所必(bi)需的(de)其他的(de)醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)獨(du)(du)立(li)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)及(ji)醫(yi)(yi)(yi)用(yong)(yong)中間件(jian)(jian)(jian)、醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)硬(ying)件(jian)(jian)(jian)產(chan)(chan)品(pin)）；2.1.6 運(yun)行環境（硬(ying)件(jian)(jian)(jian)配置、外部軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)環境、網絡條件(jian)(jian)(jian)等）。2、關于(yu)(yu)(yu)咨詢(xun)(xun)涉及(ji)到的(de)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)產(chan)(chan)品(pin)，采用(yong)(yong)哪種方式提(ti)(ti)交評(ping)(ping)(ping)價資料：免(mian)于(yu)(yu)(yu)臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價或(huo)開展臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價（同品(pin)種比對、臨(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)），需要(yao)(yao)(yao)結合產(chan)(chan)品(pin)的(de)適用(yong)(yong)范圍及(ji)《國家藥監局(ju)關于(yu)(yu)(yu)發(fa)布醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則等5項(xiang)技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則的(de)通告（2021年第73號）》的(de)5個附(fu)(fu)錄(lu)文件(jian)(jian)(jian)準備(bei)注冊(ce)申報資料。【1.醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則；2.決策是否開展醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)臨(lin)(lin)床(chuang)(chuang)試(shi)(shi)驗(yan)技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則；3.醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價等同性(xing)論證技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則；4.醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)注冊(ce)申報臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價報告技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則；5.列入免(mian)于(yu)(yu)(yu)臨(lin)(lin)床(chuang)(chuang)評(ping)(ping)(ping)價醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)目錄(lu)產(chan)(chan)品(pin)對比說明技(ji)(ji)術(shu)指(zhi)導(dao)(dao)原(yuan)(yuan)則】。《醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)注冊(ce)審(shen)查(cha)指(zhi)導(dao)(dao)原(yuan)(yuan)則（2022年修訂版(ban)）》的(de)附(fu)(fu)件(jian)(jian)(jian)：“獨(du)(du)立(li)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)產(chan)(chan)品(pin)技(ji)(ji)術(shu)要(yao)(yao)(yao)求(qiu)模板”原(yuan)(yuan)文摘抄(chao)如下：2.1.4 接(jie)口(kou)(kou)(kou) 明確軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)供用(yong)(yong)戶調用(yong)(yong)的(de)應用(yong)(yong)程序接(jie)口(kou)(kou)(kou)（API）、數據接(jie)口(kou)(kou)(kou)（含傳輸協議(yi)(yi)、存儲(chu)格(ge)式，如DICOM、HL7、JPG、PNG、私(si)有協議(yi)(yi)與格(ge)式）、產(chan)(chan)品(pin)接(jie)口(kou)(kou)(kou)（可聯合使用(yong)(yong)的(de)其他醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)獨(du)(du)立(li)軟(ruan)(ruan)(ruan)(ruan)件(jian)(jian)(jian)、醫(yi)(yi)(yi)療(liao)(liao)(liao)器(qi)(qi)(qi)(qi)(qi)(qi)(qi)械(xie)(xie)硬(ying)件(jian)(jian)(jian)產(chan)(chan)品(pin)）。2.1.5 必(bi)備(bei)軟(ruan)(ruan)(ruan)(ruan)硬(ying)件(jian)(jian)(jian)

明(ming)確(que)軟件(jian)正常(chang)(chang)運(yun)行(xing)所必需的其他的醫(yi)療(liao)(liao)器(qi)(qi)械獨立軟件(jian)（名(ming)稱、型(xing)(xing)號(hao)規格、發布版(ban)本）及醫(yi)用中(zhong)間件(jian)（名(ming)稱、型(xing)(xing)號(hao)規格、發布版(ban)本）、醫(yi)療(liao)(liao)器(qi)(qi)械硬件(jian)產品（名(ming)稱、型(xing)(xing)號(hao)規格）。2.1.6 運(yun)行(xing)環(huan)境(jing)(jing) 明(ming)確(que)軟件(jian)正常(chang)(chang)運(yun)行(xing)所需的典(dian)型(xing)(xing)運(yun)行(xing)環(huan)境(jing)(jing)，包(bao)括(kuo)硬件(jian)配置（含(han)處理器(qi)(qi)、存儲器(qi)(qi)、外設器(qi)(qi)件(jian)）、外部(bu)軟件(jian)環(huan)境(jing)(jing)（列明(ming)全部(bu)軟件(jian)的名(ming)稱、完整版(ban)本、補丁版(ban)本，使用“兼容版(ban)本”而非“以上版(ban)本”、“更高(gao)版(ban)本”）、網(wang)絡(luo)(luo)條件(jian)（含(han)網(wang)絡(luo)(luo)架(jia)構、網(wang)絡(luo)(luo)類型(xing)(xing)、網(wang)絡(luo)(luo)帶寬），涵蓋客戶端(duan)(duan)、服務(wu)器(qi)(qi)端(duan)(duan)（若適用）、云端(duan)(duan)（若適用）要求。無(wu)需重復描述必備軟硬件(jian)。

本文(wen)由(you)廣州佳譽醫(yi)療器械有限(xian)(xian)公(gong)司/佛山浩(hao)揚醫(yi)療器械有限(xian)(xian)公(gong)司聯(lian)合編輯