最新醫(yī)用口罩產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則-文庫吧資料
2025-08-11 07:14本頁面
【正文】 and huzhou, and jiaxing) seven County (wuxing, and return Ann, and Tongxiang, and jiaxing, and show water, and Wujiang, and earthquake Ze) of make, is located in remote, territory size Lake swing dotted, river port crisscross, easy hidden bat, and no Highway, traffic inconvenience. Therefore, this has bee the refuge of many, where Wujiang gentleman most of the refuge is not the fall of four townships, at this time of grave, there has been a monstrous prosperity, Nanxun town, even the neighboring Zhejiang Province, there are also some merchants to Yan Tao DUN Cun opened shop. Cang during the depression as a regional political center and military base in the area. In May 1938, Chairman Mao Zedong in the guerrilla war in the strategic issues of: North zone, South of the Lake of hongze Lake area branching stream of all enemyoccupied areas and along the coastal areas, should be well organized guerrilla and in rivers, lakes and estuaries and build lasting base nearby, as one aspect of the development of the national guerrilla.— 207 —醫(yī)用口罩產(chǎn)品注冊(cè)技術(shù)審查指導(dǎo)原則編制說明一、指導(dǎo)原則編寫的原則（一）本指導(dǎo)原則編寫的目的是用于指導(dǎo)和規(guī)范第二類醫(yī)用口罩產(chǎn)品注冊(cè)申報(bào)過程中審查人員對(duì)注冊(cè)材料的技術(shù)審評(píng)。（四）注冊(cè)檢測(cè)的典型產(chǎn)品應(yīng)關(guān)注注冊(cè)檢測(cè)產(chǎn)品是否能夠代表本注冊(cè)單元內(nèi)其他產(chǎn)品安全性和有效性。應(yīng)關(guān)注產(chǎn)品適用范圍應(yīng)與所采用的產(chǎn)品標(biāo)準(zhǔn)相符。應(yīng)對(duì)產(chǎn)品的過濾材料進(jìn)行控制，明確過濾材料的來源及質(zhì)量要求，材料應(yīng)具有相對(duì)穩(wěn)定的生產(chǎn)工藝及供貨來源以保證產(chǎn)品的質(zhì)量。如直接采用國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)作為產(chǎn)品標(biāo)準(zhǔn)的，應(yīng)注意采標(biāo)說明內(nèi)容的完整性。面罩形狀不同的口罩應(yīng)分別進(jìn)行密合性檢測(cè)，如鴨嘴形口罩密合性檢測(cè)不可覆蓋平面形口罩。典型產(chǎn)品是指能夠涵蓋本注冊(cè)單元內(nèi)全部產(chǎn)品工藝的一個(gè)或多個(gè)產(chǎn)品。通常按照口罩的分類劃分為醫(yī)用防護(hù)口罩、醫(yī)用外科口罩和一次性使用醫(yī)用口罩三個(gè)注冊(cè)單元。2. 醫(yī)用防護(hù)口罩除應(yīng)達(dá)到以上要求還應(yīng)包含：（1）應(yīng)注明使用前需進(jìn)行的檢查；（2）應(yīng)提示佩戴適合性；（3）應(yīng)給出口罩使用時(shí)間的建議；（4）應(yīng)注明濾料級(jí)別或相關(guān)說明。1. 醫(yī)用口罩產(chǎn)品說明書或包裝標(biāo)識(shí)應(yīng)至少包括以下內(nèi)容： （1）產(chǎn)品名稱、型號(hào)、規(guī)格；（2）生產(chǎn)企業(yè)名稱、注冊(cè)地址、生產(chǎn)地址、聯(lián)系方法；（3）《醫(yī)療器械生產(chǎn)企業(yè)許可證》編號(hào)、《醫(yī)療器械注冊(cè)證》編號(hào)、執(zhí)行標(biāo)準(zhǔn)代號(hào)；（4）產(chǎn)品生產(chǎn)批號(hào)； （5）產(chǎn)品使用的原材料及結(jié)構(gòu)、組成；（6
公司管理相關(guān)推薦
鄂ICP備17016276號(hào)-1