Xov xwm

Tam sim no, tus kab mob coronavirus tshiab (COVID-19) tab tom kis mus thoob plaws. Kev kis thoob ntiaj teb tab tom sim lub peev xwm ntawm txhua lub teb chaws los tawm tsam tus kab mob sib kis. Tom qab cov txiaj ntsig zoo ntawm kev tiv thaiv thiab tswj kev sib kis hauv Suav teb, ntau lub tuam txhab hauv tsev npaj siab yuav txhawb nqa lawv cov khoom los pab lwm lub teb chaws thiab thaj chaw sib koom ua ke tiv thaiv tus kab mob sib kis. Thaum Lub Peb Hlis 31, 2020, Ministry of Commerce, General Administration of Customs thiab State Drug Administration of China tau tshaj tawm cov lus tshaj tawm ua ke txog cov khoom siv kho mob ntsig txog kev tiv thaiv tus kab mob coronavirus (xws li cov khoom siv kuaj mob, lub ntsej muag kho mob, cov khaub ncaws tiv thaiv kev kho mob, lub tshuab ua pa thiab lub ntsuas kub infrared), uas tau hais tias txij lub Plaub Hlis 1, cov neeg xa khoom ntawm cov khoom no yuav tsum ua pov thawj tias lawv tau txais daim ntawv pov thawj sau npe ntawm cov khoom siv kho mob hauv Suav teb thiab ua tau raws li cov qauv zoo ntawm cov teb chaws lossis thaj chaw xa khoom. Cov neeg lis kev cai tuaj yeem tso tawm cov khoom tsuas yog tom qab lawv tau ntawv pov thawj tias tsim nyog.

Daim ntawv tshaj tawm ua ke qhia tau hais tias Tuam Tshoj muab qhov tseem ceeb rau qhov zoo ntawm cov khoom siv kho mob xa tawm. Cov hauv qab no yog cov ntsiab lus luv luv ntawm qee qhov teeb meem uas yooj yim to taub thaum xa tawm mus rau European Union thiab Tebchaws Meskas.

lub koom haum European

(1) Txog CE cim

CE yog lub zej zog European. CE cim yog EU tus qauv kev cai lij choj rau cov khoom teev nyob rau hauv EU. Hauv kev ua lag luam EU, CE daim ntawv pov thawj yog ib feem ntawm kev cai lij choj yuav tsum tau ua. Txawm hais tias cov khoom tsim los ntawm cov tuam txhab hauv EU lossis cov khoom tsim nyob rau hauv lwm lub tebchaws xav kom ncig mus los hauv kev ua lag luam EU, CE cim yuav tsum tau lo rau kom qhia tias cov khoom ua raws li cov kev cai yooj yim ntawm txoj kev tshiab ntawm kev sib haum xeeb thiab kev ua qauv. Raws li cov kev cai ntawm PPE thiab MDD / MDR, cov khoom xa tawm mus rau EU yuav tsum tau muab cim nrog CE cim.

(2) Txog Daim Ntawv Pov Thawj

Ua ntej cov khoom nkag mus rau hauv kev ua lag luam, kev muab lub cim CE lo rau yog kauj ruam kawg, qhia tias txhua yam txheej txheem tau ua tiav lawm. Raws li cov kev cai ntawm PPE thiab MDD / MDR, cov khoom siv tiv thaiv tus kheej (xws li lub ntsej muag tiv thaiv tus kheej chav kawm III) lossis cov khoom siv kho mob (xws li lub ntsej muag kho mob chav kawm I) yuav tsum tau soj ntsuam los ntawm lub cev tau txais kev ceeb toom (NB) uas tau lees paub los ntawm European Union. Daim ntawv pov thawj CE ntawm cov khoom siv kho mob yuav tsum tau muab los ntawm lub cev tau txais kev ceeb toom, thiab daim ntawv pov thawj yuav tsum muaj tus lej ntawm lub cev tau txais kev ceeb toom, uas yog, tus lej plaub tus lej tshwj xeeb.

(3) Piv txwv ntawm cov kev cai rau cov khoom tiv thaiv kev sib kis

1. Cov ntaub npog qhov ncauj muab faib ua cov ntaub npog qhov ncauj kho mob thiab cov ntaub npog qhov ncauj tiv thaiv tus kheej.

Raws li en14683, cov ntaub npog qhov ncauj tau muab faib ua ob pawg: hom I thiab hom II / IIR. Cov ntaub npog qhov ncauj hom I tsuas yog tsim rau cov neeg mob thiab lwm tus neeg kom txo qhov kev pheej hmoo ntawm kev kis tus kab mob thiab kev sib kis, tshwj xeeb tshaj yog thaum muaj cov kab mob sib kis lossis kev sib kis thoob plaws. Cov ntaub npog qhov ncauj hom II feem ntau yog siv los ntawm cov kws kho mob hauv chav phais lossis lwm qhov chaw kho mob uas muaj cov kev cai zoo sib xws.

2. Cov khaub ncaws tiv thaiv: cov khaub ncaws tiv thaiv tau muab faib ua cov khaub ncaws tiv thaiv kev kho mob thiab cov khaub ncaws tiv thaiv tus kheej, thiab nws cov kev cai tswj hwm zoo ib yam li cov ntawm lub ntsej muag. Tus qauv European ntawm cov khaub ncaws tiv thaiv kev kho mob yog en14126.

（4） Xov xwm tshiab tshaj plaws

EU 2017 / 745 (MDR) yog txoj cai tshiab ntawm EU txog cov khoom siv kho mob. Raws li qhov hloov kho tshiab ntawm 93 / 42 / EEC (MDD), txoj cai no yuav pib siv thiab yuav siv tag nrho rau lub Tsib Hlis 26, 2020. Thaum Lub Peb Hlis 25, European Commission tau tshaj tawm ib qho kev thov kom ncua kev siv MDR los ntawm ib xyoos, uas tau xa thaum ntxov Lub Plaub Hlis rau kev pom zoo los ntawm European Parliament thiab Council ua ntej thaum kawg Lub Tsib Hlis. Ob leeg MDD thiab MDR qhia meej txog kev ua tau zoo ntawm cov khoom kom ntseeg tau tias muaj kev noj qab haus huv thiab kev nyab xeeb ntawm cov neeg siv.