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各省(sheng)、自治區、直轄市食品藥(yao)品監(jian)督管(guan)理(li)局：

　　為加強醫療器(qi)械經營(ying)(ying)監(jian)(jian)(jian)管(guan)(guan)(guan)，根據《醫療器(qi)械經營(ying)(ying)監(jian)(jian)(jian)督管(guan)(guan)(guan)理(li)辦法》（國家食(shi)品(pin)藥品(pin)監(jian)(jian)(jian)督管(guan)(guan)(guan)理(li)總局令第(di)8號）和(he)《醫療器(qi)械經營(ying)(ying)企業分(fen)類分(fen)級監(jian)(jian)(jian)督管(guan)(guan)(guan)理(li)規(gui)(gui)定(ding)》（食(shi)藥監(jian)(jian)(jian)械監(jian)(jian)(jian)〔2015〕158號），總局組織(zhi)制定(ding)了《醫療器(qi)械經營(ying)(ying)環(huan)節重點(dian)(dian)(dian)監(jian)(jian)(jian)管(guan)(guan)(guan)目錄及(ji)現場(chang)檢查重點(dian)(dian)(dian)內(nei)容》，現印發給你們，請(qing)按照(zhao)《醫療器(qi)械經營(ying)(ying)企業分(fen)類分(fen)級監(jian)(jian)(jian)督管(guan)(guan)(guan)理(li)規(gui)(gui)定(ding)》對《醫療器(qi)械經營(ying)(ying)環(huan)節重點(dian)(dian)(dian)監(jian)(jian)(jian)管(guan)(guan)(guan)目錄及(ji)現場(chang)檢查重點(dian)(dian)(dian)內(nei)容》中所列品(pin)種(zhong)的經營(ying)(ying)實施重點(dian)(dian)(dian)監(jian)(jian)(jian)管(guan)(guan)(guan)。

　　附(fu)件：醫療器械經營環節重點監管(guan)目錄及現(xian)場檢查重點內容(rong)

食品藥品監管總局
2015年8月(yue)17日