元旦(dan)起,一(yi)批跟(gen)相關的新規施行。快來(lai)和小編一(yi)起看看吧!
一(yi)是(shi)《認證機(ji)構管理辦法》
2018年1月1日起施(shi)行(xing)
新修(xiu)訂的(de)(de)《認(ren)(ren)(ren)(ren)證(zheng)(zheng)機(ji)構(gou)管理(li)辦法》一.將認(ren)(ren)(ren)(ren)證(zheng)(zheng)機(ji)構(gou)設立審批由前置修(xiu)改為(wei)后置。二.取(qu)消對承擔(dan)認(ren)(ren)(ren)(ren)證(zheng)(zheng)機(ji)構(gou)認(ren)(ren)(ren)(ren)證(zheng)(zheng)業(ye)務的(de)(de)子公(gong)司資質的(de)(de)審批。三.取(qu)消境外認(ren)(ren)(ren)(ren)證(zheng)(zheng)機(ji)構(gou)在中國境內(nei)設立代表(biao)機(ji)構(gou)的(de)(de)審批。四.調整、修(xiu)改和細化(hua)罰則,明(ming)確認(ren)(ren)(ren)(ren)證(zheng)(zheng)機(ji)構(gou)“出具虛(xu)假的(de)(de)認(ren)(ren)(ren)(ren)證(zheng)(zheng)結論或者出具的(de)(de)認(ren)(ren)(ren)(ren)證(zheng)(zheng)結論嚴重(zhong)失實”的(de)(de)情形。五.明(ming)確采取(qu)“雙(shuang)隨機(ji)、一公(gong)開(kai)”和分類監管方式。六是建立認(ren)(ren)(ren)(ren)證(zheng)(zheng)機(ji)構(gou)及相關(guan)人員失信懲戒制度。
二是《標準(zhun)化法(fa)》
2018年1月(yue)1日開始(shi)施行
《標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)(hua)法(fa)(fa)(fa)(fa)》30年(nian)來第一(yi)次修(xiu)(xiu)訂,變化(hua)(hua)很(hen)大(da),被稱為(wei)“大(da)修(xiu)(xiu)”,在(zai)很(hen)多方(fang)面都有重大(da)突破。擴(kuo)大(da)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)范(fan)圍(wei)。現(xian)行法(fa)(fa)(fa)(fa)規定(ding)(ding)的(de)(de)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)范(fan)圍(wei)主要(yao)(yao)限于工業(ye)領域。新法(fa)(fa)(fa)(fa)則(ze)將(jiang)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)范(fan)圍(wei)擴(kuo)大(da)到農業(ye)、工業(ye)、服務業(ye)以及社會(hui)事業(ye)等領域需要(yao)(yao)統(tong)(tong)一(yi)的(de)(de)技術要(yao)(yao)求(qiu)。建(jian)立(li)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)(hua)協(xie)調(diao)(diao)機制(zhi)。設區的(de)(de)市(shi)級(ji)以上(shang)地(di)方(fang)人民(min)政府可以根據工作需要(yao)(yao)建(jian)立(li)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)(hua)協(xie)調(diao)(diao)機制(zhi),統(tong)(tong)籌協(xie)調(diao)(diao)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)(hua)工作重大(da)事項。鼓勵(li)積極參(can)與國際標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)(hua)活動。建(jian)立(li)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)化(hua)(hua)獎勵(li)制(zhi)度(du)。加強強制(zhi)性(xing)(xing)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)的(de)(de)統(tong)(tong)一(yi)管(guan)理(li)(li)。新法(fa)(fa)(fa)(fa)明確取消強制(zhi)性(xing)(xing)行業(ye)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)和(he)地(di)方(fang)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun),僅保留強制(zhi)性(xing)(xing)國家標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)一(yi)級(ji),以實現(xian)“一(yi)個市(shi)場、一(yi)個底線(xian)、一(yi)個標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)”。同時將(jiang)強制(zhi)性(xing)(xing)國家標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)定(ding)(ding)范(fan)圍(wei)嚴格限定(ding)(ding)在(zai)保障人身(shen)健康和(he)生命財產安(an)全、國家安(an)全、生態環境安(an)全以及滿足社會(hui)經濟管(guan)理(li)(li)基本需要(yao)(yao)的(de)(de)技術要(yao)(yao)求(qiu)。賦(fu)予設區的(de)(de)市(shi)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)制(zhi)定(ding)(ding)權。發揮技術委員會(hui)的(de)(de)作用。明確強制(zhi)性(xing)(xing)標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)應(ying)當免費(fei)向社會(hui)公(gong)開。賦(fu)予團體標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)法(fa)(fa)(fa)(fa)律地(di)位。建(jian)立(li)企業(ye)產品和(he)服務標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)自我聲明公(gong)開和(he)監督(du)制(zhi)度(du)。增設標(biao)(biao)(biao)(biao)準(zhun)(zhun)(zhun)(zhun)(zhun)(zhun)實施后評估制(zhi)度(du)。
三是《嬰幼兒配(pei)方乳(ru)粉產品配(pei)方注冊管理(li)辦法(fa)》
過渡期截止2018年1月1日
《嬰幼兒(er)配(pei)(pei)方乳(ru)(ru)(ru)粉(fen)(fen)產(chan)品(pin)(pin)(pin)配(pei)(pei)方注(zhu)(zhu)冊管(guan)理(li)辦法》2016年(nian)(nian)10月1日起(qi)開始實施,但為保障嬰幼兒(er)配(pei)(pei)方乳(ru)(ru)(ru)粉(fen)(fen)的市場供應(ying),國(guo)(guo)(guo)家食(shi)品(pin)(pin)(pin)藥品(pin)(pin)(pin)監管(guan)總(zong)(zong)局發(fa)布了關于配(pei)(pei)方注(zhu)(zhu)冊管(guan)理(li)過(guo)渡(du)期(qi)(qi)(qi)的公告(gao),過(guo)渡(du)期(qi)(qi)(qi)截止(zhi)2018年(nian)(nian)1月1日,此后(hou)生(sheng)產(chan)的國(guo)(guo)(guo)產(chan)或進(jin)口配(pei)(pei)方乳(ru)(ru)(ru)粉(fen)(fen)應(ying)當取得配(pei)(pei)方注(zhu)(zhu)冊證書,此前(qian)生(sheng)產(chan)的可(ke)銷(xiao)售(shou)至(zhi)保質(zhi)期(qi)(qi)(qi)結束。目前(qian),國(guo)(guo)(guo)家質(zhi)檢總(zong)(zong)局、國(guo)(guo)(guo)家食(shi)品(pin)(pin)(pin)藥品(pin)(pin)(pin)監管(guan)總(zong)(zong)局發(fa)布公告(gao)再次明(ming)確,以一般(ban)貿易方式進(jin)口的嬰幼兒(er)配(pei)(pei)方乳(ru)(ru)(ru)粉(fen)(fen)產(chan)品(pin)(pin)(pin),其生(sheng)產(chan)日期(qi)(qi)(qi)在2018年(nian)(nian)1月1日(含)之后(hou)的,應(ying)當取得國(guo)(guo)(guo)家食(shi)品(pin)(pin)(pin)藥品(pin)(pin)(pin)監管(guan)總(zong)(zong)局的產(chan)品(pin)(pin)(pin)配(pei)(pei)方注(zhu)(zhu)冊并在銷(xiao)售(shou)包(bao)裝的標簽(qian)上注(zhu)(zhu)明(ming)注(zhu)(zhu)冊號。
四是(shi)《網絡餐(can)飲服(fu)務食品安全監督(du)管理(li)辦(ban)法》
于2018年1月(yue)1日起施行
《網(wang)(wang)絡(luo)(luo)(luo)(luo)(luo)餐(can)(can)(can)飲(yin)服務(wu)(wu)食(shi)(shi)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)監督管(guan)理(li)辦(ban)(ban)法》明(ming)確“線(xian)(xian)上線(xian)(xian)下一致”原(yuan)則。《辦(ban)(ban)法》規定(ding)(ding),入網(wang)(wang)餐(can)(can)(can)飲(yin)服務(wu)(wu)提供者(zhe)應(ying)(ying)(ying)當具有(you)實(shi)體(ti)經營(ying)門店并(bing)依法取得(de)食(shi)(shi)品(pin)(pin)(pin)經營(ying)許可證(zheng)(zheng),并(bing)按照食(shi)(shi)品(pin)(pin)(pin)經營(ying)許可證(zheng)(zheng)載明(ming)的(de)主體(ti)業態(tai)、經營(ying)項目從事經營(ying)活動,不得(de)超范圍經營(ying)。網(wang)(wang)絡(luo)(luo)(luo)(luo)(luo)銷售的(de)餐(can)(can)(can)飲(yin)食(shi)(shi)品(pin)(pin)(pin)應(ying)(ying)(ying)當與實(shi)體(ti)店銷售的(de)餐(can)(can)(can)飲(yin)食(shi)(shi)品(pin)(pin)(pin)質量安(an)(an)全(quan)(quan)保(bao)持(chi)一致。《辦(ban)(ban)法》規定(ding)(ding),網(wang)(wang)絡(luo)(luo)(luo)(luo)(luo)餐(can)(can)(can)飲(yin)服務(wu)(wu)第三方平臺提供者(zhe)需(xu)要(yao)履行建立食(shi)(shi)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)相關制度、設(she)置專(zhuan)門的(de)食(shi)(shi)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)管(guan)理(li)機(ji)構(gou)、配(pei)備(bei)專(zhuan)職食(shi)(shi)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)管(guan)理(li)人員、審查(cha)登記并(bing)公示入網(wang)(wang)餐(can)(can)(can)飲(yin)服務(wu)(wu)提供者(zhe)的(de)許可信(xin)息、如實(shi)記錄網(wang)(wang)絡(luo)(luo)(luo)(luo)(luo)訂餐(can)(can)(can)的(de)訂單信(xin)息、對(dui)入網(wang)(wang)餐(can)(can)(can)飲(yin)服務(wu)(wu)提供者(zhe)的(de)經營(ying)行為進行抽查(cha)和監測(ce)等義(yi)(yi)務(wu)(wu);入網(wang)(wang)餐(can)(can)(can)飲(yin)服務(wu)(wu)提供者(zhe)需(xu)要(yao)履行公示信(xin)息、制定(ding)(ding)和實(shi)施(shi)原(yuan)料控制、嚴格加(jia)工(gong)過程(cheng)控制、定(ding)(ding)期維護(hu)設(she)施(shi)設(she)備(bei)等義(yi)(yi)務(wu)(wu)。明(ming)確送(song)(song)(song)餐(can)(can)(can)人員和送(song)(song)(song)餐(can)(can)(can)過程(cheng)要(yao)求。《辦(ban)(ban)法》規定(ding)(ding),送(song)(song)(song)餐(can)(can)(can)人員應(ying)(ying)(ying)當保(bao)持(chi)個(ge)人衛生(sheng),使用安(an)(an)全(quan)(quan)、無(wu)害的(de)配(pei)送(song)(song)(song)容器,保(bao)證(zheng)(zheng)配(pei)送(song)(song)(song)過程(cheng)食(shi)(shi)品(pin)(pin)(pin)不受污染。送(song)(song)(song)餐(can)(can)(can)單位要(yao)加(jia)強對(dui)送(song)(song)(song)餐(can)(can)(can)人員的(de)培訓和管(guan)理(li)。配(pei)送(song)(song)(song)有(you)保(bao)鮮、保(bao)溫、冷藏或(huo)冷凍(dong)等特殊(shu)要(yao)求食(shi)(shi)品(pin)(pin)(pin)的(de),要(yao)采取能保(bao)證(zheng)(zheng)食(shi)(shi)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)的(de)保(bao)存、配(pei)送(song)(song)(song)措施(shi)。明(ming)確開展網(wang)(wang)絡(luo)(luo)(luo)(luo)(luo)餐(can)(can)(can)飲(yin)服務(wu)(wu)食(shi)(shi)品(pin)(pin)(pin)安(an)(an)全(quan)(quan)監測(ce)。
五是(shi)《醫療器械臨床試驗機(ji)構條件和(he)備案管理辦(ban)法》
自2018年(nian)1月1日起施(shi)行
食品(pin)藥(yao)(yao)品(pin)監管總局會同(tong)國家(jia)(jia)衛(wei)生(sheng)計(ji)生(sheng)委聯合發(fa)布《醫療器(qi)械臨床試驗機構條(tiao)件和備案管理(li)辦法》。按照國家(jia)(jia)食品(pin)藥(yao)(yao)品(pin)監管總局要(yao)求(qiu)(qiu),自(zi)2018年1月(yue)1日(ri)起,所有在產(chan)的(de)醫療器(qi)械生(sheng)產(chan)企業(ye)應當全(quan)部(bu)符(fu)合質(zhi)量(liang)管理(li)規(gui)范(fan)的(de)要(yao)求(qiu)(qiu),不符(fu)合規(gui)范(fan)要(yao)求(qiu)(qiu)的(de)一(yi)律(lv)停止生(sheng)產(chan)。自(zi)2018年1月(yue)1日(ri)后,檢查(cha)發(fa)現生(sheng)產(chan)企業(ye)未(wei)(wei)依照《醫療器(qi)械監督(du)管理(li)條(tiao)例(li)》規(gui)定(ding)建(jian)立質(zhi)量(liang)管理(li)體系(xi)并保持有效(xiao)運行的(de),依照第(di)六十六條(tiao)處罰(fa);對質(zhi)量(liang)管理(li)體系(xi)不符(fu)合要(yao)求(qiu)(qiu)且未(wei)(wei)依照《醫療器(qi)械監督(du)管理(li)條(tiao)例(li)》規(gui)定(ding)整改、停止生(sheng)產(chan)、報告(gao)的(de),依照第(di)六十七條(tiao)處罰(fa)。
六是《出口食品生產企業備案(an)管理規定》
2018年(nian)1月(yue)1日實施
2017年11月14日,國家質檢(jian)(jian)總(zong)局發布新(xin)(xin)(xin)(xin)修訂(ding)的(de)(de)(de)《出(chu)(chu)(chu)口(kou)食(shi)(shi)(shi)品(pin)(pin)生(sheng)產(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)(ye)備(bei)(bei)案(an)(an)(an)管(guan)理(li)(li)規定(ding)》。進(jin)(jin)一(yi)步(bu)(bu)簡政放(fang)權(quan),取消由直屬檢(jian)(jian)驗(yan)檢(jian)(jian)疫局辦(ban)理(li)(li)備(bei)(bei)案(an)(an)(an)的(de)(de)(de)限制性規定(ding),備(bei)(bei)案(an)(an)(an)管(guan)理(li)(li)工作由分支機構具體實施;積極采信第三方(fang)認(ren)證(zheng)(zheng)結果;延長《出(chu)(chu)(chu)口(kou)食(shi)(shi)(shi)品(pin)(pin)生(sheng)產(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)(ye)備(bei)(bei)案(an)(an)(an)證(zheng)(zheng)明(ming)》有效(xiao)期(qi)至5年;專家評審時間縮短三分之一(yi)、企(qi)(qi)業(ye)(ye)(ye)換(huan)證(zheng)(zheng)所需(xu)時間縮短三分之二。進(jin)(jin)行(xing)(xing)全(quan)方(fang)位監管(guan),分為(wei)事(shi)前(qian)(qian)事(shi)中和(he)事(shi)后(hou)三個部分,事(shi)前(qian)(qian)在風險分析的(de)(de)(de)基礎(chu)上(shang)提出(chu)(chu)(chu)分類管(guan)理(li)(li);事(shi)中實施監管(guan)聯(lian)動,將對(dui)出(chu)(chu)(chu)口(kou)食(shi)(shi)(shi)品(pin)(pin)生(sheng)產(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)(ye)的(de)(de)(de)監督檢(jian)(jian)查和(he)對(dui)相(xiang)關(guan)認(ren)證(zheng)(zheng)活動的(de)(de)(de)監督檢(jian)(jian)查結合進(jin)(jin)行(xing)(xing);事(shi)后(hou)明(ming)確信息(xi)管(guan)理(li)(li),進(jin)(jin)一(yi)步(bu)(bu)明(ming)確備(bei)(bei)案(an)(an)(an)企(qi)(qi)業(ye)(ye)(ye)信息(xi)公(gong)布的(de)(de)(de)渠道,公(gong)開(kai)執法結果,接收社會監督。同(tong)時新(xin)(xin)(xin)(xin)修訂(ding)的(de)(de)(de)管(guan)理(li)(li)規定(ding)中還豐富和(he)細(xi)化(hua)了監管(guan)手段,新(xin)(xin)(xin)(xin)增(zeng)“法律責任”一(yi)章(zhang),設立警告等行(xing)(xing)政處(chu)罰措(cuo)施。引入(ru)食(shi)(shi)(shi)品(pin)(pin)防(fang)護(hu)計(ji)劃(hua),要求(qiu)出(chu)(chu)(chu)口(kou)食(shi)(shi)(shi)品(pin)(pin)生(sheng)產(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)(ye)建立實施包括(kuo)食(shi)(shi)(shi)品(pin)(pin)防(fang)護(hu)計(ji)劃(hua)在內的(de)(de)(de)食(shi)(shi)(shi)品(pin)(pin)安全(quan)衛生(sheng)控(kong)制體系。新(xin)(xin)(xin)(xin)規實施后(hou),出(chu)(chu)(chu)口(kou)食(shi)(shi)(shi)品(pin)(pin)生(sheng)產(chan)(chan)(chan)企(qi)(qi)業(ye)(ye)(ye)備(bei)(bei)案(an)(an)(an)有效(xiao)期(qi)將延長1年,備(bei)(bei)案(an)(an)(an)評審和(he)換(huan)證(zheng)(zheng)流(liu)程時限大(da)大(da)縮短,審批環(huan)節減(jian)少,進(jin)(jin)一(yi)步(bu)(bu)方(fang)便企(qi)(qi)業(ye)(ye)(ye)出(chu)(chu)(chu)口(kou),但(dan)同(tong)時新(xin)(xin)(xin)(xin)規定(ding)的(de)(de)(de)要求(qiu)更加嚴格具體,強調風險分析在出(chu)(chu)(chu)口(kou)食(shi)(shi)(shi)品(pin)(pin)企(qi)(qi)業(ye)(ye)(ye)備(bei)(bei)案(an)(an)(an)管(guan)理(li)(li)中的(de)(de)(de)指導作用(yong),表現出(chu)(chu)(chu)對(dui)食(shi)(shi)(shi)品(pin)(pin)安全(quan)衛生(sheng)隱患的(de)(de)(de)零容忍。
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