醫(yī)療器械的 MDR 流程
MDR 是對(duì)《醫(yī)療器械法規(guī)》的統(tǒng)稱(chēng)。該規(guī)范于 2017 年 5 月 25 日生效，是在醫(yī)療器械合規(guī)性重新評(píng)估范圍內(nèi)引入的一項(xiàng)安排，盡管其合規(guī)性之前已獲得認(rèn)證。該規(guī)范旨在確定醫(yī)療器械是否符合新系統(tǒng)。?
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