《關于疫情(qing)防控用醫療器械先生(sheng)(sheng)產(chan)(chan)后審批有(you)關事項的通知(zhi)》強調,應(ying)急生(sheng)(sheng)產(chan)(chan)應(ying)符(fu)(fu)合《醫療器械監督(du)管(guan)(guan)理條例(li)》《醫療器械生(sheng)(sheng)產(chan)(chan)質(zhi)量(liang)(liang)管(guan)(guan)理規范》等相(xiang)關要求(qiu)。應(ying)急生(sheng)(sheng)產(chan)(chan)的產(chan)(chan)品(pin)說明(ming)書、標簽(qian)除符(fu)(fu)合《醫療器械說明(ming)書和(he)標簽(qian)管(guan)(guan)理規定》外(wai),還應(ying)在產(chan)(chan)品(pin)最小銷售單元(yuan)包裝正面醒(xing)目(mu)標注(zhu)“僅供防控疫情(qing)應(ying)急使用”字樣(yang)。獲準緊急生(sheng)(sheng)產(chan)(chan)的企業要切實加強質(zhi)量(liang)(liang)管(guan)(guan)理,確保產(chan)(chan)品(pin)的安全有(you)效,質(zhi)量(liang)(liang)可控。