Izindaba

Njengamanje, ubhubhane olusha lwe-coronavirus (COVID-19) luyasabalala. Ukusabalala komhlaba wonke kuhlola amandla awo wonke amazwe ukulwa nalolu bhubhane. Ngemuva kwemiphumela emihle yokuvimbela nokulawula ubhubhane eChina, amabhizinisi amaningi asekhaya ahlose ukukhuthaza imikhiqizo yawo ukusiza amanye amazwe nezifunda ngokuhlanganyela ukumelana nalolu bhubhane. Ngomhla zingama-31 kuNdasa, 2020, uMnyango Wezohwebo, IGeneral Administration of Fors and State Drug Administration of China bakhiphe isimemezelo esihlanganyelwe mayelana nemishini yezokwelapha ehlobene nokunqanda ubhubhane lwe-coronavirus (njengezinto ezihlonza abantu, imaski yezokwelapha, izingubo zokuzivikela, ama-ventilators kanye ama-thermometers e-infrared), okusho ukuthi kusukela ngo-Ephreli 1, abathumeli bemikhiqizo enjalo kumele bafakazele ukuthi bathole isitifiketi sokubhaliswa kwemishini yezokwelapha e-China Futhi bahlangabezane nezindinganiso zekhwalithi zamazwe noma izifunda ezithumela ngaphandle. Amasiko angakwazi ukukhulula izimpahla kuphela ngemva kokuqinisekiswa ukuthi zifanelekile.

Isimemezelo esihlanganyelwe sibonisa ukuthi i-China ibheka ukubaluleka okukhulu kwekhwalithi yempahla yezokwelapha ethunyelwa kwamanye amazwe. Okulandelayo isifinyezo sezinye izinkinga okulula ukudideka lapho zithunyelwa e-European Union nase-United States.

iyuniyani yase-Europe

(1) Mayelana ne-CE mark

CE umphakathi waseYurophu. Umaki we-CE uyimodeli yokulawula ye-EU yemikhiqizo esohlwini lwe-EU. Emakethe ye-EU, isitifiketi se-CE singesesitifiketi somthetho oyimpoqo. Ukuthi noma imikhiqizo ekhiqizwe ngamabhizinisi ngaphakathi kwe-EU noma imikhiqizo ekhiqizwe kwamanye amazwe ifuna ukuzungeza ngokukhululeka emakethe ye-EU, umaki we-CE kufanele unamathiselwe ukukhombisa ukuthi imikhiqizo ithobelana nezidingo eziyisisekelo zendlela entsha yokuvumelana nobuchwepheshe. Ngokwezidingo ze-PPE ne-MDD / MDR, imikhiqizo ethunyelwa e-EU kufanele ibhalwe uphawu lwe-CE.

(2) Mayelana Nezitifiketi

Ukunamathisela umaki we-CE kuyisinyathelo sokugcina ngaphambi kokuba umkhiqizo ungene emakethe, okubonisa ukuthi zonke izinqubo seziqediwe. Ngokwezidingo ze-PPE kanye ne-MDD / MDR, okokusebenza kokuzivikela (njengemaski yokuzivikela yesigaba III) noma okokusebenza kwezokwelapha (njengokuvala inzalo yemaski yezokwelapha yesigaba I) kufanele kuhlolwe yinhlangano eyazisiwe (NB) eqashelwa yi-European Union. . Isitifiketi se-CE yensiza yezokwelapha kufanele sikhishwe indikimba eyazisiwe, futhi isitifiketi kufanele sibe nenombolo yebhodi elaziswayo, okungukuthi, ikhodi enamadijithi amane ehlukile.

(3) Izibonelo zezimfuneko zemikhiqizo yokuvimbela ubhubhane

1. Izifihlabuso zihlukaniswe zaba izifihla-buso zezokwelapha kanye nezifihla-buso zokuzivikela.

Ngokusho kwe-en14683, imaski ihlukaniswe izigaba ezimbili: uhlobo I kanye nohlobo II / IIR. Imaski yohlobo I ifaneleka kuphela iziguli kanye nabanye abantu ukunciphisa ingozi yokutheleleka nokudluliselwa, ikakhulukazi esimweni sezifo ezithathelwanayo noma ubhadane. Imaski yohlobo II isetshenziswa ikakhulukazi odokotela egumbini lokuhlinza noma kwenye indawo yezokwelapha enezidingo ezifanayo.

2. Izingubo ezivikelayo: Izingubo zokuzivikela zihlukaniswe zaba izingubo zokuzivikela zezokwelapha nezingubo zokuzivikela, futhi izidingo zazo zokuphatha ngokuyisisekelo zifana nalezo zamamaski. Izinga laseYurophu lezingubo zokuvikela zezokwelapha lithi en14126.

(4) Izindaba zakamuva

I-EU 2017/745 (MDR) iyisimiso esisha sedivayisi yezokwelapha ye-EU. Njengenguqulo ethuthukisiwe ye-93 / 42 / EEC (MDD), lo mthethonqubo uzoqala ukusebenza futhi usetshenziswe ngokugcwele ngoMeyi 26, 2020. NgoMashi 25, i-European Commission yamemezela isiphakamiso sokuhlehlisa ukuqaliswa kwe-MDR ngonyaka owodwa, eyethulwe ekuqaleni kuka-April ukuze ivunywe yiPhalamende laseYurophu kanye noMkhandlu ngaphambi kokuphela kukaMeyi. Kokubili i-MDD ne-MDR icacisa ukusebenza komkhiqizo ukuze kuqinisekiswe impilo nokuphepha kwabasebenzisi.